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Journal Article Review
Dr V K Sahu
Molecular Psychiatry
Oct 2015
Optimal duration of risperidone or olanzapine
adjunctive ...
3:1 ratio.
Sadock BJ,Sadock VA, Ruiz P, Course and Prognosis, Mood Disorder, Kaplana & Sadock’s synopsis of
Psychiatry, 11...
Inclusion Criteria:
Inclusion criteria (Continued..)
(CGI-S)
or
(YMRS)
Exclusion criteria:
Trial design and interventions:
52
Trial design and interventions (Contd):
Three groups:
‘0-weeks’ group
Trial design and interventions (Contd):
24-weeks’ group:
‘52-weeks’ group:
Continued risperidone or olanzapine for 52
w...
Trial design and interventions (Contd):
BZD
anti-parkinsonian medication
Trial design and interventions (Contd):
Patients were allowed to receive
Study Outcomes:
Clinical Global Impression-Improvement (CGI-I)
(last 2 were assessed 2 week onwards)
Study Outcomes (Continued):
Primary outcome measure:
15
15
3
3
Hospitalization mood symptoms
Secondary outcome measures :
Primary outcome events manic depressive
Sample size:
type I error rate
80% power
Patient Flow and Characteristics:
Patient Flow and Characteristics (Continued):
34 (21%) discontinued
Mean follow-up times 18, 25 and 24
Results
Results
Treatment Variables
 Primary outcomes:
 39 primary events
(depression = 25, mania
= 14) among 52 patients
in the 0-weeks group
 29 events (...
Primary outcomes (Continued):
29
time to any mood episode longer both 52-weeks
24-weeks 0-weeks
similar 52-
weeks and 2...
Hazard ratio (HR
0.53
0.63
relative to
1.18
Secondary outcomes:
27 70
Time to a manic episode longer
Secondary outcomes (Continued):
Time to a manic episode shorter 52
not
Time to a depressive episode
Secondary outcomes (Continued):
The time to discontinuation -
Secondary outcomes (Continued):
Subgroup analysis:
Olanzapine subgroup
Time to any mood episode longer not
Subgroup analysis:
Risperidone subgroup
Time to any mood
 Patients in the 52-weeks group
gained significantly more weight
(also clinically significant weight gain
(⩾7% or more of...
Adverse events:
First study
maintenance
bipolar I after
Time to relapse of any mood episode was significantly
longer in the group that c...
There was a trend for longer time to relapse of any mood
episode in the 52-weeks group compared with the 0-weeks
group.
First study
maintenance
bipolar I after
not
not
less recurrence
for 24
S.NO Criteria Yes (2) Partial
(1)
No (0) NA
1 Question/ objective sufficiently described?
√
2 Study design evident & appro...
S No Criteria Yes (2) Partial (1) No (0) NA
5 If interventional and random allocation
was possible, was it described? √
6 ...
S No Criteria Yes (2) Partial (1) No (0) NA
9 Sample size appropriate?
√
10 Analytic methods described/justified and
appro...
Thank you
Journal club CANMAT
Journal club CANMAT
Journal club CANMAT
Journal club CANMAT
Journal club CANMAT
Journal club CANMAT
Journal club CANMAT
Journal club CANMAT
Journal club CANMAT
Journal club CANMAT
Journal club CANMAT
Journal club CANMAT
Journal club CANMAT
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Journal club CANMAT

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Optimal duration of risperidone or olanzapine adjunctive therapy to mood stabilizer following remission of a manic episode: A CANMAT randomized double-blind trial

Published in: Health & Medicine
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Journal club CANMAT

  1. 1. Journal Article Review Dr V K Sahu Molecular Psychiatry Oct 2015 Optimal duration of risperidone or olanzapine adjunctive therapy to mood stabilizer following remission of a manic episode: A CANMAT randomized double-blind trial
  2. 2. 3:1 ratio. Sadock BJ,Sadock VA, Ruiz P, Course and Prognosis, Mood Disorder, Kaplana & Sadock’s synopsis of Psychiatry, 11th edition, 370-372 Judd LL, Akiskal HS, Schettler PJ, Endicott J, Maser J, Solomon DA et al. The longterm natural history of the weekly symptomatic status of bipolar I disorder. Arch Gen Psychiatry 2002; 59: 530–537
  3. 3. Inclusion Criteria:
  4. 4. Inclusion criteria (Continued..) (CGI-S) or (YMRS)
  5. 5. Exclusion criteria:
  6. 6. Trial design and interventions: 52
  7. 7. Trial design and interventions (Contd): Three groups: ‘0-weeks’ group
  8. 8. Trial design and interventions (Contd): 24-weeks’ group: ‘52-weeks’ group: Continued risperidone or olanzapine for 52 weeks. All patients continued the same mood stabilizer
  9. 9. Trial design and interventions (Contd): BZD anti-parkinsonian medication
  10. 10. Trial design and interventions (Contd): Patients were allowed to receive
  11. 11. Study Outcomes: Clinical Global Impression-Improvement (CGI-I) (last 2 were assessed 2 week onwards)
  12. 12. Study Outcomes (Continued):
  13. 13. Primary outcome measure: 15 15 3 3 Hospitalization mood symptoms
  14. 14. Secondary outcome measures : Primary outcome events manic depressive
  15. 15. Sample size: type I error rate 80% power
  16. 16. Patient Flow and Characteristics:
  17. 17. Patient Flow and Characteristics (Continued): 34 (21%) discontinued Mean follow-up times 18, 25 and 24
  18. 18. Results
  19. 19. Results Treatment Variables
  20. 20.  Primary outcomes:  39 primary events (depression = 25, mania = 14) among 52 patients in the 0-weeks group  29 events (depression = 23, mania = 6) among 54 patients in the 24-weeks group 
  21. 21. Primary outcomes (Continued): 29 time to any mood episode longer both 52-weeks 24-weeks 0-weeks similar 52- weeks and 24-weeks groups.
  22. 22. Hazard ratio (HR 0.53 0.63 relative to 1.18
  23. 23. Secondary outcomes: 27 70 Time to a manic episode longer
  24. 24. Secondary outcomes (Continued): Time to a manic episode shorter 52 not Time to a depressive episode
  25. 25. Secondary outcomes (Continued): The time to discontinuation -
  26. 26. Secondary outcomes (Continued):
  27. 27. Subgroup analysis: Olanzapine subgroup Time to any mood episode longer not
  28. 28. Subgroup analysis: Risperidone subgroup Time to any mood
  29. 29.  Patients in the 52-weeks group gained significantly more weight (also clinically significant weight gain (⩾7% or more of baseline weight)  Average change in glucose, cholesterol or triglycerides levels from baseline to last follow-up were similar in all three groups whether including all patients or in either antipsychotic subgroup
  30. 30. Adverse events:
  31. 31. First study maintenance bipolar I after Time to relapse of any mood episode was significantly longer in the group that continued atypical antipsychotic adjunctive therapy for 24 weeks compared with the group that had their atypical antipsychotic discontinued at study entry.
  32. 32. There was a trend for longer time to relapse of any mood episode in the 52-weeks group compared with the 0-weeks group.
  33. 33. First study maintenance bipolar I after
  34. 34. not
  35. 35. not
  36. 36. less recurrence for 24
  37. 37. S.NO Criteria Yes (2) Partial (1) No (0) NA 1 Question/ objective sufficiently described? √ 2 Study design evident & appropriate? √ 3 Method of subjective/comparison group selection or source of information/ input variable describe and appropriate? √ 4 Subject ( and comparison group, if applicable) characteristics sufficiently described? √
  38. 38. S No Criteria Yes (2) Partial (1) No (0) NA 5 If interventional and random allocation was possible, was it described? √ 6 If interventional and blinding of investigators was possible, was it reported? √ 7 If interventional and blinding of subjects was possible, was it reported? √ 8 Outcome and (if applicable) exposure measures well-defined and robust to measurement/misclassification bias? Means of assessment reported √
  39. 39. S No Criteria Yes (2) Partial (1) No (0) NA 9 Sample size appropriate? √ 10 Analytic methods described/justified and appropriate? √ 11 Controlled for confounding? √ 12 Results reported in sufficient detail? √ 13 Conclusions supported by the results? √
  40. 40. Thank you

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