This study evaluated the tolerability and effectiveness of aripiprazole long-acting injectable (LAI) in 18 outpatients with schizoaffective disorder. Patients received monthly injections of 400mg aripiprazole LAI for 6 months. Effectiveness was measured using PANSS and CGI-S scales, showing statistically significant improvements. Tolerability was good, with weight gain and akathisia reported as adverse effects in a small number of patients. While limited by sample size, the study provides preliminary evidence that aripiprazole LAI may be an effective and well-tolerated treatment for schizoaffective disorder. A larger randomized controlled trial is needed.

1. An Evaluation of the Tolerability and Effectiveness of Aripiprazole
Long-acting Injectable (LAI) in Outpatients with Schizoaffective Disorder
Terrance J. Bellnier, RPh, MPA 1,2, Geoff Brown 1,2, Tulio Ortega, MD2, Robert Insull, PhD2 , Michael Pratt, PhD2 1. SUNY University at Buffalo, 2. GPI Clinical Research
Abstracts
Introduction
Age 46 + 9 (39-62) years
Gender 16-male, 2-females
Ethnicity 78% - Caucasian, 27% - African American, 17% -
Hispanic
Lifetime
hospitalizations
2 + 1
Duration of
diagnosis
14 + 3 years
Baseline
antipsychotic
Aripiprazole 11%, Quetiapine 22%, Paliperidone 67%
Subjects: Results Tolerability
Adverse Events: Causality-
probably related
Percent (No. Subjects)
Weight Gain 11 (2)
Akathisia 5 (1)
Insomnia 5 (1)
Somnolence 5 (1)
Discussion
Effectiveness Schizoaffective disorder is a clinical challenge to treat due to the multiplicity of
concurrent symptoms. Patients diagnosed with schizoaffective disorder present with
psychotic symptoms that include: delusions, hallucinations, disorganized speech,
thinking or behavior and negative symptoms. In addition, patients need to have
significant mood symptoms sufficient to meet criteria for major depressive episode,
manic episode or a mixed episode concurrent with psychotic symptoms. Prognosis
may vary between the subtypes where bipolar may be slightly better than depressive
schizoaffective disorder, as the latter usually results in long-term mood disturbances.
Various strategies have been employed to treat schizoaffective disorder but empirical
data suggests that optimizing treatment with second-generation antipsychotics might
be the most effective. Aripiprazole/Abilify® is an atypical antipsychotic that has partial
agonistic activity at dopamine D2 and serotonin 5-HT1A receptors, and has
antagonistic activity at 5-HT2A receptors. Oral aripirprazole has demonstrated in
numerous trials that it is effective in treating schizoaffective disorder
Our study demonstrates that Aripirazole LAI is a effective, well tolerated, cost effective
treatment for schizoaffective disorder bipolar or depressive. Due to the limitations of
our evaluation, these results may not be applicable to the general population. A
randomized placebo controlled clinical trial is warranted to further evaluate the role of
Aripiprazole LAI in the treatment of schizoaffective disorder.
Presented at CPNP 2017 Annual Meeting: April
22-24, Phoenix, Arizona
Background: Patients diagnosed with schizoaffective disorder experience psychotic symptoms,
typical of schizophrenia, with overlapping mood symptoms of depression or mania.
Schizoaffective disorder is rare and affects around 0.3% of the population. The only FDA
approved drug for treatment of schizoaffective disorder, and the only long acting injectable
available, is paliperidone. Aripiprazole has FDA approvals for a variety of mental illnesses
including but not limited to schizophrenia, bipolar I, and augmentation of depression. We
investigated the use of Abilify Maintena in treating schizoaffective disorder.
Method: This is a naturalistic evaluation of aripiprazole LAI in community mental health and private
practice outpatients diagnosed with DSM-V schizoaffective disorder. Patients were selected who
wished to change current antipsychotic treatment based on side effects, ineffective response, or
lack of adherence. Effectiveness was measured by the PANSS and CGI-S. Vital signs, BARS,
SAS, AIMS and spontaneous patient reporting were used to measure tolerability. All measures
were completed at baseline (Pre) and 6 months of treatment with aripiprazole LAI (Post).
Results: 18 patients with a DSM-V diagnosis of schizoaffective disorder were identified. Patient
demographics included: age 46 +/- 9, African American-3 (17%), Hispanic-1 (5%), Caucasian-14
(78%), and male-16 (89%). Subjects had 2+/-1 life time hospitalizations and the duration of
schizoaffective diagnosis was 14+/- 3 years. Baseline oral antipsychotics included: Aripiprazole
2(11%), Quetiapine 4 (22%), and Paliperidone 12 (67%). Effectiveness was measured by change
in PANSS (Pre 59.9 – Post 39.2, P=. 002) and CGI-S (Pre 4.1 – Post 2.9, P<. 0001). There was no
statistical difference Pre and Post with the BARS, SAS, AIMS, and vital signs. The most common
side effects reported by patients were weight gain- 2(11%) and akathisia 1(5%). All patients
received 400mg monthly of aripiprazole LAI. No patients discontinued treatment with aripiprazole
LAI due to side effects.
Conclusion: Our sample size and study design limit our ability to make population inferences.
However, the present study provides evidence that aripiprazole LAI is a tolerable and effective
treatment for patients with schizoaffective disorder. A randomized placebo controlled clinical trial is
warranted to further evaluate the role of aripiprazole LAI in the treatment of schizoaffective
disorder.
Patients diagnosed with schizoaffective disorder (SAD) experience psychotic symptoms,
typical of schizophrenia, with overlapping mood symptoms of depression or mania. The
disorder is rare, affecting approximately 0.3% of the population [1].
Most of the data surrounding treatment comes from hybrid study samples containing
both patients with schizophrenia and SAD [2]. Approved treatment options for SAD are
extremely limited. Paliperidone/Invega ®, is the only FDA approved drug for treatment
of SAD, and Invega ® Sustenna ®, is the only long acting injectable (LAI) option
available [3]. Clozapine holds approval for reducing suicidal risk associated with SAD,
but does not carry approval for treatment [4]. There is high off-label use of both atypical
antipsychotics, and mood stabilizers in the SAD setting. The utilization of a mood
stabilizer inherently is warranted due to the affective component of the disease, but still
no agents have yet to be approved. The meager evidence for treatment results in a lack
of consensus on how to manage SAD with a pharmacotherapeutic approach [2].
Given that patients with SAD can have poor medication adherence, comparable to that
of, or worse than, patients with schizophrenia [5], unlocking the therapeutic potential in
other LAI atypical antipsychotics may assist in further management of SAD.
Aripiprazole/Abilify® is an atypical antipsychotic that has partial agonistic activity at
dopamine D2 and serotonin 5-HT1A receptors, and has antagonistic activity at 5-HT2A
receptors. The drug is FDA approved for a wide variety of mental illnesses and has two
different long acting injectable formulations [6,7]. We investigated the use of Abilify®
Maintena® in treating schizoaffective disorder.
Service Utilization
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More/Mental-Health-Conditions/Schizoaffective-Disorder>
2. Vieta, Eduard. "Developing an individualized treatment plan for patients with schizoaffective disorder: from pharmacotherapy to psychoeducation." The Journal of c
psychiatry 71 (2009): 14-19.
3. Invega ® [Package Insert] Janssen Pharmaceuticals Inc., Titusville NJ: May 17th, 2016
Accessed: April 2nd, 2017. http://www.invega.com/prescribing-information
4. Clozaril ® [Package Insert] Novartis Pharmaceuticals Inc., New York, NY: September 2016
Accessed: April 2nd, 2016. http://clozaril.com/wp-content/themes/eyesite/pi/2016i0627_Clozaril_PI_09302016.pdf
5. Byerly, Matthew J., et al. "A trial of compliance therapy in outpatients with schizophrenia or schizoaffective disorder." The Journal of clinical psychiatry 66.8 (2005):
1001.
6. Abilify Maintena ® [Package Insert] Otsuka Pharmaceutical Co., Tokyo, JPN: 2016
Accessed: April 2nd, 2016 < https://www.otsuka-us.com/media/static/Abilify-M-PI.pdf?_ga=1.202194196.445008734.1491165004>
7. Abilify Aristada ® [Package Insert] Alkermes Pharmaceuticals., Waltham, MA: February 2017
nd
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