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BLOCK 1 TRIMESTER 1 2018: TLAW 101 – BUSINESS LAW
– ASSIGNMENT QUESTIONS
Assessment Details
Due date: Friday, 6 April 2018 11-59 PM IN TURNITIN
Weighting: 30%
Length: 1500 words (+/- 10%), correctly referenced
Objectives
Answer the following questions with reference to the relevant
common law and equity
principles operating in Australia concerning contracts plus
related and other transactions. Do
not consider the effects of legislation potentially applicable
other than that specifically
identified. Students may make whatever additional factual
and/or legal assumptions are
necessary or convenient. And students must write about 1500
words (+/- 10%), or about 750
(+/- 10%) words per 15 mark allocation.
Assessment Task
Question 1 15 Marks
The University of Millennia called for tenders for supplies of
green seed for its surrounds, with
a closing date of 1 June.
The following tenders were submitted:
• Greenland hand-delivered its tender on 29 May, which went
into the tender box.
• Enviro posted its tender on 15 May. This letter was received
by the University on 17 May,
but, by being submitted so early, one of the administrative
assistants filed it with the
intention of later putting it in the box when she was properly
organised.
• Plant Forever posted its tender on 30 May. This letter arrived
on 2 June but nevertheless
was put into the tender box.
It transpired that only two of the tenders were considered by the
relevant administrative
officials of the University. Although the tender by Enviro was
the lowest and contained the
most attractive features, the administrative assistant forgot
where she had filed it and did not
find it again until a week after the decision was made.
Greenland’s tender was the next lowest, but because of rumours
about its unreliability, the
University awarded the contract to Plant Forever. The
University posted a letter to Plant
Forever advising that its tender was successful. Unfortunately,
this letter never reached Plant
Forever because it was destroyed by a disgruntled postal worker
who had just been made
redundant. Since it had not heard from the University, Plant
Forever instead committed its
full stock of seed to another contract with a regional council.
The University became aware of the full situation concerning
the tender by Enviro and the
position in which Plant Forever now finds itself. It seeks advice
concerning its contractual
position in relation to all three tenders.
2
Question 2
15 Marks
On 1 October Footloose Pty Ltd placed the following notice in
the Daily News newspaper:
Special Shoes Special Discounts
Footloose Pty Ltd is awaiting the delivery of the latest summer
collection shoes from Italy.
Styles include the new slingback sandals and wedge heels.
Prices start at $2000 per hundred
pairs (certain styles only); big discounts may be negotiated for
bulk orders. All inquiries to Ms
Simone, Sales Manager, on 1400 765 432 or by fax on 06 9234
567.
On 2 October Famous Footwear sent the following fax to Ms
Simone:
We accept your offer in the Daily News. We wish to order 500
pairs at $2000 per hundred.
Details on delivery to follow.
On 4 October James, the owner of shoe retailer James’s Shoes,
which had several regional
stores throughout Australia, sent the following fax to Ms
Simone at Footloose:
We refer to your notice in the Daily News and would like to
purchase 2000 pairs of slingback
sandals. Our best price is $30,000 including GST and delivery.
Please advise.
On 6 October Ms Simone sent the following fax to James:
Footloose will sell 2000 pairs of slingback sandals for $30,000,
excluding delivery. Payment by
cash or bank cheque is due on delivery. Please advise.
James immediately wrote the following letter to Ms Simone,
which was mailed on 8 October:
We refer to your fax of 6 October and are prepared to meet you
on those terms. Please let me
know the earliest delivery date.
On 10 October Ms Simone telephoned James. After a short
discussion James faxed Ms Simone
a copy of the letter of 8 October. The parties agreed that
James’s Shoes would take delivery
of the sandals from Footloose’s Sydney warehouse on 1
November.
Referring to relevant case law and giving reasons for your
propositions, discuss the legal effect
of each of the forms of correspondence between Footloose,
Famous Footwear and James’s
Shoes that took place between 1 October and 10 October.
Assessment Criteria
Fail
You will have shown evidence of the following:
• the written expression is poor and difficult to understand
• the answer is poorly organised
• referencing is generally inadequate
• lack of familiarity with the legislation and its application
• failure to identify and address the issues in the question
3
• reasoning and application demonstrated is poor.
Pass
You will have:
• made a conscientious attempt to address the topic and/or
answer the question
• shown evidence of having done the required reading and of
having understood the
reading
• presented a reasonable argument to back up your conclusions
• demonstrated a reasonable level of spelling and grammatical
usage
• used referencing but this may need improvement
• issues that may need to be identified and addressed in more
depth.
Credit
You will have:
• addressed the topic and/or answered the question directly
• presented soundly based arguments and backed these up with
reasons
• gone beyond description to analysis of key issues
• used the English language well
• shown evidence of reading widely
• demonstrated understanding of the reading
• used referencing that is satisfactory.
Distinction
You will have:
• met the above criteria for a credit
• demonstrated the attainment of a high degree of understanding
of the concepts of
the course
• demonstrated deep insight into the application of knowledge
and skills acquired to
complex theoretical and practical situations
• used referencing correctly
• made reference to all appropriate legislation.
High Distinction
You will have:
• met the above criteria for a distinction
• demonstrated the attainment of an outstanding level of
achievement regarding the
objectives of this course
• demonstrated an interesting and/ or original approach/ idea/
argument
• demonstrated mastery of the relevant referencing system
4
• ensured conclusions are backed by well-reasoned arguments
demonstrating a
detailed insight and analysis of issues
• ensured references are made to the appropriate legislation for
particular issues.
END OF QUESTIONS
5
Full Terms & Conditions of access and use can be found at
http://www.tandfonline.com/action/journalInformation?journalC
ode=rcmh20
Journal of Child & Adolescent Mental Health
ISSN: 1728-0583 (Print) 1728-0591 (Online) Journal homepage:
http://www.tandfonline.com/loi/rcmh20
Controversies in the use of antidepressants in
children and adolescents: A decade since the
storm and where do we stand now?
Soraya Seedat
To cite this article: Soraya Seedat (2014) Controversies in the
use of antidepressants in children
and adolescents: A decade since the storm and where do we
stand now?, Journal of Child &
Adolescent Mental Health, 26:2, iii-v, DOI:
10.2989/17280583.2014.938497
To link to this article:
https://doi.org/10.2989/17280583.2014.938497
Published online: 16 Jul 2014.
Submit your article to this journal
Article views: 900
View related articles
View Crossmark data
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14.938497&domain=pdf&date_stamp=2014-07-16
http://crossmark.crossref.org/dialog/?doi=10.2989/17280583.20
14.938497&domain=pdf&date_stamp=2014-07-16
EDITORIAL
Controversies in the use of antidepressants in children and
adolescents: A decade since the storm and where do we
stand now?
As we focus in this special issue on new developments in
diagnosis and treatment (with a particular
emphasis on paediatric psychopharmacology), I thought that the
time was opportune to pause
and reflect on a potentially life-threatening medical condition in
children and adolescents: Major
Depressive Disorder (MDD). The prevalence of MDD in pre-
pubertal children (2.8%) doubles
after puberty (5.8% in adolescents 13–18 years of age), is
twofold more preponderant in post-pu-
bertal girls than boys, and is characterised by episodic
recurrences in adolescence and adulthood.
About half of all adolescents with current MDD will have a
subsequent depressive episode over the
next five years. Paediatric MDD is arguably the most important
risk factor for suicide and, in fact,
accounts for more than half of adolescent suicides. However, it
is a potentially preventable and
highly treatable cause of other psychiatric morbidity, alcohol
and drug use, academic and social
impairment, and disability. The World Health Organization has
identified adolescent depression
as one of the key priority areas for diagnosis and treatment in
low and middle income countries,
where the burden of the disorder is greatest. Timely recognition
and treatment of youth is therefore
critical. Over the past decade the use of antidepressants in
children and adolescents has raised
widespread public concern and debate. Despite the passage of
time and the emergence of new
evidence (including unpublished data), professional opinions
among psychiatrists continue to be
divided on issues of antidepressant effectiveness and safety.
Currently, there are only two FDA (US
Food and Drug Administration)-approved medications for the
treatment of paediatric MDD: fluoxe-
tine (for children and adolescents aged 7–17 years) and
escitalopram (for adolescents aged 12–17
years). Additional evidence from randomised controlled trials
(RCTs) indicates that sertraline and
citalopram, in children 7–17 years of age, are also beneficial for
the treatment of MDD but these
agents are not FDA approved. Placebo response rates in trials of
paediatric MDD exceed 30%,
perhaps not surprising considering the multi-site nature of these
RCTs and the inclusion of young
patients with less severe depressive symptomatology.
In pondering the evidence that guides the prescription of
antidepressants in children and adoles-
cents, it is prudent to take a trip down memory lane. In 2003
there were worrying signals from
RCTS of paroxetine, indicating a lack of efficacy of this
selective serotonin reuptake inhibitor (SSRI)
relative to placebo in paediatric depression and an elevated risk
of harmful outcomes that included
self-harm and suicidal behaviour. The FDA and the UK
Medicines and Healthcare Products
Regulatory Agency (MHRA) subsequently issued health
advisories warning about the increased
risk of suicidality with antidepressants in this age group. The
FDA then commissioned a widely
publicised data review of antidepressant RCTs in child and
adolescent MDD. Based on conclu-
sions drawn from the review, the FDA requested pharmaceutical
companies to include a ‘black
box’ warning to the package labelling of all antidepressants
about the increased risk of suicidality in
children under 18 years (Isacsson and Rich 2014). No completed
suicides had occurred in any of
the RCTs that were reviewed. In 2007 this was extended to
include young adults under 25 years of
age. Around the same time, the Treatment for Adolescents with
Depression Study (TADS), the first
trial to compare the effectiveness of fluoxetine, cognitive
behaviour therapy (CBT), their combina-
tion, or placebo, in adolescents with MDD, found that
fluoxetine was superior to placebo at three
months. However, CBT was not superior to placebo. Over time
the three active treatments (fluoxe-
tine, CBT and fluoxetine + CBT) had comparable efficacy, in
response and remission rates (March
et al. 2004). Of note, the risk of suicidal ideation and attempts
was low across all three treatments.
http://dx.doi.org/10.2989/17280583.2014.938497 iii
Further analysis of TADS data showed that both fluoxetine and
combination therapy were at least
as cost-effective in the short term as other treatments commonly
used in primary care.
The benefits of antidepressants for internalising disorders in
youth were also supported by a
meta-analysis assessing the efficacy of antidepressants and risk
of reported suicidal ideation/
suicide attempts for treatment of paediatric MDD, obsessive-
compulsive disorder (OCD), and
non-OCD anxiety disorders published in 2007 (Bridge et al.
2007). Antidepressants were superior
to placebo and were associated with a 3% increase in suicidal
ideation/attempts compared with a
2% rate on placebo. The antidepressant-placebo difference in
risk of 1% was not statistically signif-
icant and, more importantly, there were no completed suicides
in any of the RCTs included in the
meta-analysis.
Further interesting (and confusing) data came to light. In the
five years preceding the black
box warning (1999–2003), there had been an increase in the
diagnosis of MDD coupled with an
increase in the use of SSRIs across all ages. However, in the
five years following the black box
warning there had been the opposite effect! There was a notable
decrease in the diagnosis of
depression and the prescription of antidepressants in countries
such as the USA, UK, Sweden,
Canada and Australia. More disturbing was an increase in the
number of completed suicides in
these countries (except UK where there was no difference).
Notably, in a recently published study
of all cases of suicide in 10–19 year olds in Sweden (Isacsson
and Ahlner 2013) that included
toxicology data on antidepressants taken immediately before
death, there was a substantial
increase in suicide cases in the five years after the warning. As
this increase was notable in youth
who were not on antidepressants, the authors have suggested
that “these truly suicidal persons
might have been denied antidepressants or abstained from them,
due to the ‘black box’ and then
committed suicide because of untreated depression” (Isacsson
and Ahlner 2013: 6).
So where do we stand with the numerous systematic reviews
meta-analyses and new studies
that have been published since the black box? First, it needs to
be emphasised that there have
been no completed suicides in any of the placebo-controlled
RCTs of newer generation antide-
pressants in children and adolescents. Second, the benefit–risk
ratio for the use of antidepres-
sants, more specifically fluoxetine, in children and adolescents
with moderate-to-severe depression
is favourable (Soutullo and Figueroa-Quintana 2013). Close
observation and monitoring of youth
before and following initiation of treatment, regardless of the
type of treatment, should be part and
parcel of routine care. Third, CBT or interpersonal therapy
should be considered as a first-line in
this age group, even in moderate-to-severe paediatric
depression. Fourth, adding CBT to an antide-
pressant does not appear to improve response in paediatric
MDD in the longer term, challenging
the often held notion that combining these treatments trumps
giving either alone. Fifth, as adoles-
cent MDD has a relapsing and remitting course continuing
treatment for at least 6 to 12 months
after acute phase treatment (antidepressant or CBT) has been
demonstrated to prevent relapse.
Finally, evidence that antidepressant treatments improving the
quality of life among children and
adolescents with depressive or anxiety disorders is inconclusive
and more research is required
in this regard. In summary, evidence relating to the risk–benefit
profile of antidepressants is still
contradictory and not much has changed since 2003. Closing the
knowledge gaps in cost-effective
diagnosis, treatment and prevention of child and adolescent
MDD, using family based approaches,
remains a priority.
References
Bridge JA, Iyengar S, Salary CB, Barbe RP, Birmaher B, Pincus
HA, Ren L, Brent DA. 2007. Clinical response
and risk for reported suicidal ideation and suicide attempts in
pediatric antidepressant treatment: a
meta-analysis of randomized controlled trials. Journal of the
American Medical Association 297: 1683–1696.
Isacsson G, Ahlner J. 2014. Antidepressants and the risk of
suicide in young persons—prescription trends and
toxicological analyses. Acta Psychiatrica Scandinavica 129:
296–302.
Isacsson G, Rich CL. 2014. Antidepressant drugs and the risk of
suicide in children and adolescents. Paediatric
Drugs 16: 115–122.
iv
March J, Silva S, Petrycki S, Curry J, Wells K, Fairbank J,
Burns B, Domino M, McNulty S, Vitiello B, Severe
J; Treatment for Adolescents With Depression Study (TADS)
Team. 2004. Fluoxetine, cognitive-behavioral
therapy, and their combination for adolescents with depression:
Treatment for Adolescents With Depression
Study (TADS) randomized controlled trial. Journal of the
American Medical Association 292: 807–820.
Soutullo C, Figueroa-Quintana A. 2013. When do you prescribe
antidepressants to depressed children? Current
Psychiatry Reports 15: 366–373.
Soraya Seedat
Editor-in-Chief, Journal of Child & Adolescent Mental Health
email: [email protected]
v

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1 BLOCK 1 TRIMESTER 1 2018 TLAW 101 – BUSINESS LAW – ASSI.docx

  • 1. 1 BLOCK 1 TRIMESTER 1 2018: TLAW 101 – BUSINESS LAW – ASSIGNMENT QUESTIONS Assessment Details Due date: Friday, 6 April 2018 11-59 PM IN TURNITIN Weighting: 30% Length: 1500 words (+/- 10%), correctly referenced Objectives Answer the following questions with reference to the relevant common law and equity principles operating in Australia concerning contracts plus related and other transactions. Do not consider the effects of legislation potentially applicable other than that specifically identified. Students may make whatever additional factual and/or legal assumptions are necessary or convenient. And students must write about 1500 words (+/- 10%), or about 750 (+/- 10%) words per 15 mark allocation. Assessment Task Question 1 15 Marks The University of Millennia called for tenders for supplies of green seed for its surrounds, with a closing date of 1 June.
  • 2. The following tenders were submitted: • Greenland hand-delivered its tender on 29 May, which went into the tender box. • Enviro posted its tender on 15 May. This letter was received by the University on 17 May, but, by being submitted so early, one of the administrative assistants filed it with the intention of later putting it in the box when she was properly organised. • Plant Forever posted its tender on 30 May. This letter arrived on 2 June but nevertheless was put into the tender box. It transpired that only two of the tenders were considered by the relevant administrative officials of the University. Although the tender by Enviro was the lowest and contained the most attractive features, the administrative assistant forgot where she had filed it and did not find it again until a week after the decision was made. Greenland’s tender was the next lowest, but because of rumours about its unreliability, the University awarded the contract to Plant Forever. The University posted a letter to Plant Forever advising that its tender was successful. Unfortunately, this letter never reached Plant Forever because it was destroyed by a disgruntled postal worker who had just been made redundant. Since it had not heard from the University, Plant Forever instead committed its full stock of seed to another contract with a regional council.
  • 3. The University became aware of the full situation concerning the tender by Enviro and the position in which Plant Forever now finds itself. It seeks advice concerning its contractual position in relation to all three tenders. 2 Question 2 15 Marks On 1 October Footloose Pty Ltd placed the following notice in the Daily News newspaper: Special Shoes Special Discounts Footloose Pty Ltd is awaiting the delivery of the latest summer collection shoes from Italy. Styles include the new slingback sandals and wedge heels. Prices start at $2000 per hundred pairs (certain styles only); big discounts may be negotiated for bulk orders. All inquiries to Ms Simone, Sales Manager, on 1400 765 432 or by fax on 06 9234 567. On 2 October Famous Footwear sent the following fax to Ms Simone: We accept your offer in the Daily News. We wish to order 500 pairs at $2000 per hundred. Details on delivery to follow.
  • 4. On 4 October James, the owner of shoe retailer James’s Shoes, which had several regional stores throughout Australia, sent the following fax to Ms Simone at Footloose: We refer to your notice in the Daily News and would like to purchase 2000 pairs of slingback sandals. Our best price is $30,000 including GST and delivery. Please advise. On 6 October Ms Simone sent the following fax to James: Footloose will sell 2000 pairs of slingback sandals for $30,000, excluding delivery. Payment by cash or bank cheque is due on delivery. Please advise. James immediately wrote the following letter to Ms Simone, which was mailed on 8 October: We refer to your fax of 6 October and are prepared to meet you on those terms. Please let me know the earliest delivery date. On 10 October Ms Simone telephoned James. After a short discussion James faxed Ms Simone a copy of the letter of 8 October. The parties agreed that James’s Shoes would take delivery of the sandals from Footloose’s Sydney warehouse on 1 November. Referring to relevant case law and giving reasons for your propositions, discuss the legal effect of each of the forms of correspondence between Footloose, Famous Footwear and James’s Shoes that took place between 1 October and 10 October.
  • 5. Assessment Criteria Fail You will have shown evidence of the following: • the written expression is poor and difficult to understand • the answer is poorly organised • referencing is generally inadequate • lack of familiarity with the legislation and its application • failure to identify and address the issues in the question 3 • reasoning and application demonstrated is poor. Pass You will have: • made a conscientious attempt to address the topic and/or answer the question • shown evidence of having done the required reading and of having understood the reading • presented a reasonable argument to back up your conclusions • demonstrated a reasonable level of spelling and grammatical usage • used referencing but this may need improvement • issues that may need to be identified and addressed in more
  • 6. depth. Credit You will have: • addressed the topic and/or answered the question directly • presented soundly based arguments and backed these up with reasons • gone beyond description to analysis of key issues • used the English language well • shown evidence of reading widely • demonstrated understanding of the reading • used referencing that is satisfactory. Distinction You will have: • met the above criteria for a credit • demonstrated the attainment of a high degree of understanding of the concepts of the course • demonstrated deep insight into the application of knowledge and skills acquired to complex theoretical and practical situations • used referencing correctly • made reference to all appropriate legislation. High Distinction You will have: • met the above criteria for a distinction
  • 7. • demonstrated the attainment of an outstanding level of achievement regarding the objectives of this course • demonstrated an interesting and/ or original approach/ idea/ argument • demonstrated mastery of the relevant referencing system 4 • ensured conclusions are backed by well-reasoned arguments demonstrating a detailed insight and analysis of issues • ensured references are made to the appropriate legislation for particular issues.
  • 8. END OF QUESTIONS 5 Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalC ode=rcmh20 Journal of Child & Adolescent Mental Health ISSN: 1728-0583 (Print) 1728-0591 (Online) Journal homepage: http://www.tandfonline.com/loi/rcmh20 Controversies in the use of antidepressants in children and adolescents: A decade since the storm and where do we stand now?
  • 9. Soraya Seedat To cite this article: Soraya Seedat (2014) Controversies in the use of antidepressants in children and adolescents: A decade since the storm and where do we stand now?, Journal of Child & Adolescent Mental Health, 26:2, iii-v, DOI: 10.2989/17280583.2014.938497 To link to this article: https://doi.org/10.2989/17280583.2014.938497 Published online: 16 Jul 2014. Submit your article to this journal Article views: 900 View related articles View Crossmark data http://www.tandfonline.com/action/journalInformation?journalC ode=rcmh20 http://www.tandfonline.com/loi/rcmh20 http://www.tandfonline.com/action/showCitFormats?doi=10.298 9/17280583.2014.938497 https://doi.org/10.2989/17280583.2014.938497 http://www.tandfonline.com/action/authorSubmission?journalCo de=rcmh20&show=instructions http://www.tandfonline.com/action/authorSubmission?journalCo de=rcmh20&show=instructions http://www.tandfonline.com/doi/mlt/10.2989/17280583.2014.93 8497 http://www.tandfonline.com/doi/mlt/10.2989/17280583.2014.93 8497
  • 10. http://crossmark.crossref.org/dialog/?doi=10.2989/17280583.20 14.938497&domain=pdf&date_stamp=2014-07-16 http://crossmark.crossref.org/dialog/?doi=10.2989/17280583.20 14.938497&domain=pdf&date_stamp=2014-07-16 EDITORIAL Controversies in the use of antidepressants in children and adolescents: A decade since the storm and where do we stand now? As we focus in this special issue on new developments in diagnosis and treatment (with a particular emphasis on paediatric psychopharmacology), I thought that the time was opportune to pause and reflect on a potentially life-threatening medical condition in children and adolescents: Major Depressive Disorder (MDD). The prevalence of MDD in pre- pubertal children (2.8%) doubles after puberty (5.8% in adolescents 13–18 years of age), is twofold more preponderant in post-pu- bertal girls than boys, and is characterised by episodic recurrences in adolescence and adulthood. About half of all adolescents with current MDD will have a subsequent depressive episode over the next five years. Paediatric MDD is arguably the most important risk factor for suicide and, in fact, accounts for more than half of adolescent suicides. However, it is a potentially preventable and highly treatable cause of other psychiatric morbidity, alcohol and drug use, academic and social impairment, and disability. The World Health Organization has identified adolescent depression as one of the key priority areas for diagnosis and treatment in low and middle income countries,
  • 11. where the burden of the disorder is greatest. Timely recognition and treatment of youth is therefore critical. Over the past decade the use of antidepressants in children and adolescents has raised widespread public concern and debate. Despite the passage of time and the emergence of new evidence (including unpublished data), professional opinions among psychiatrists continue to be divided on issues of antidepressant effectiveness and safety. Currently, there are only two FDA (US Food and Drug Administration)-approved medications for the treatment of paediatric MDD: fluoxe- tine (for children and adolescents aged 7–17 years) and escitalopram (for adolescents aged 12–17 years). Additional evidence from randomised controlled trials (RCTs) indicates that sertraline and citalopram, in children 7–17 years of age, are also beneficial for the treatment of MDD but these agents are not FDA approved. Placebo response rates in trials of paediatric MDD exceed 30%, perhaps not surprising considering the multi-site nature of these RCTs and the inclusion of young patients with less severe depressive symptomatology. In pondering the evidence that guides the prescription of antidepressants in children and adoles- cents, it is prudent to take a trip down memory lane. In 2003 there were worrying signals from RCTS of paroxetine, indicating a lack of efficacy of this selective serotonin reuptake inhibitor (SSRI) relative to placebo in paediatric depression and an elevated risk of harmful outcomes that included self-harm and suicidal behaviour. The FDA and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) subsequently issued health advisories warning about the increased
  • 12. risk of suicidality with antidepressants in this age group. The FDA then commissioned a widely publicised data review of antidepressant RCTs in child and adolescent MDD. Based on conclu- sions drawn from the review, the FDA requested pharmaceutical companies to include a ‘black box’ warning to the package labelling of all antidepressants about the increased risk of suicidality in children under 18 years (Isacsson and Rich 2014). No completed suicides had occurred in any of the RCTs that were reviewed. In 2007 this was extended to include young adults under 25 years of age. Around the same time, the Treatment for Adolescents with Depression Study (TADS), the first trial to compare the effectiveness of fluoxetine, cognitive behaviour therapy (CBT), their combina- tion, or placebo, in adolescents with MDD, found that fluoxetine was superior to placebo at three months. However, CBT was not superior to placebo. Over time the three active treatments (fluoxe- tine, CBT and fluoxetine + CBT) had comparable efficacy, in response and remission rates (March et al. 2004). Of note, the risk of suicidal ideation and attempts was low across all three treatments. http://dx.doi.org/10.2989/17280583.2014.938497 iii Further analysis of TADS data showed that both fluoxetine and combination therapy were at least as cost-effective in the short term as other treatments commonly used in primary care. The benefits of antidepressants for internalising disorders in youth were also supported by a
  • 13. meta-analysis assessing the efficacy of antidepressants and risk of reported suicidal ideation/ suicide attempts for treatment of paediatric MDD, obsessive- compulsive disorder (OCD), and non-OCD anxiety disorders published in 2007 (Bridge et al. 2007). Antidepressants were superior to placebo and were associated with a 3% increase in suicidal ideation/attempts compared with a 2% rate on placebo. The antidepressant-placebo difference in risk of 1% was not statistically signif- icant and, more importantly, there were no completed suicides in any of the RCTs included in the meta-analysis. Further interesting (and confusing) data came to light. In the five years preceding the black box warning (1999–2003), there had been an increase in the diagnosis of MDD coupled with an increase in the use of SSRIs across all ages. However, in the five years following the black box warning there had been the opposite effect! There was a notable decrease in the diagnosis of depression and the prescription of antidepressants in countries such as the USA, UK, Sweden, Canada and Australia. More disturbing was an increase in the number of completed suicides in these countries (except UK where there was no difference). Notably, in a recently published study of all cases of suicide in 10–19 year olds in Sweden (Isacsson and Ahlner 2013) that included toxicology data on antidepressants taken immediately before death, there was a substantial increase in suicide cases in the five years after the warning. As this increase was notable in youth who were not on antidepressants, the authors have suggested that “these truly suicidal persons
  • 14. might have been denied antidepressants or abstained from them, due to the ‘black box’ and then committed suicide because of untreated depression” (Isacsson and Ahlner 2013: 6). So where do we stand with the numerous systematic reviews meta-analyses and new studies that have been published since the black box? First, it needs to be emphasised that there have been no completed suicides in any of the placebo-controlled RCTs of newer generation antide- pressants in children and adolescents. Second, the benefit–risk ratio for the use of antidepres- sants, more specifically fluoxetine, in children and adolescents with moderate-to-severe depression is favourable (Soutullo and Figueroa-Quintana 2013). Close observation and monitoring of youth before and following initiation of treatment, regardless of the type of treatment, should be part and parcel of routine care. Third, CBT or interpersonal therapy should be considered as a first-line in this age group, even in moderate-to-severe paediatric depression. Fourth, adding CBT to an antide- pressant does not appear to improve response in paediatric MDD in the longer term, challenging the often held notion that combining these treatments trumps giving either alone. Fifth, as adoles- cent MDD has a relapsing and remitting course continuing treatment for at least 6 to 12 months after acute phase treatment (antidepressant or CBT) has been demonstrated to prevent relapse. Finally, evidence that antidepressant treatments improving the quality of life among children and adolescents with depressive or anxiety disorders is inconclusive and more research is required in this regard. In summary, evidence relating to the risk–benefit
  • 15. profile of antidepressants is still contradictory and not much has changed since 2003. Closing the knowledge gaps in cost-effective diagnosis, treatment and prevention of child and adolescent MDD, using family based approaches, remains a priority. References Bridge JA, Iyengar S, Salary CB, Barbe RP, Birmaher B, Pincus HA, Ren L, Brent DA. 2007. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized controlled trials. Journal of the American Medical Association 297: 1683–1696. Isacsson G, Ahlner J. 2014. Antidepressants and the risk of suicide in young persons—prescription trends and toxicological analyses. Acta Psychiatrica Scandinavica 129: 296–302. Isacsson G, Rich CL. 2014. Antidepressant drugs and the risk of suicide in children and adolescents. Paediatric Drugs 16: 115–122. iv March J, Silva S, Petrycki S, Curry J, Wells K, Fairbank J, Burns B, Domino M, McNulty S, Vitiello B, Severe J; Treatment for Adolescents With Depression Study (TADS) Team. 2004. Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. Journal of the
  • 16. American Medical Association 292: 807–820. Soutullo C, Figueroa-Quintana A. 2013. When do you prescribe antidepressants to depressed children? Current Psychiatry Reports 15: 366–373. Soraya Seedat Editor-in-Chief, Journal of Child & Adolescent Mental Health email: [email protected] v