Phase 2
Completed N=309
A Study of ALKS 3831 in Adults With Schizophrenia
Source: ClinicalTrials.gov NCT01903837 ↗Enrolled (actual)
309
Serious AEs
3.0%
Results posted
Sep 2021
Primary outcomePrimary: Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score — -2.9; -1.5; -2.7; -2.5 units on a scale — p=0.3
Summary
This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted in 2 parts. The study duration for each subject will be approximately 33 weeks and will include 25 study visits.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score |
-2.9; -1.5; -2.7; -2.5 | 0.3 |
| SECONDARY Percent Change in Body Weight (Kilogram) From Baseline to Day 92 |
4.1; 2.8; 2.1; 2.9; 5.3; 3.8 | 0.006 sig |
| SECONDARY Absolute Change in Body Weight (kg) From Baseline to Day 92 |
2.9; 2.1; 1.5; 2.2; 3.8; 2.9 | 0.018 sig |
| SECONDARY Percentage of Subjects Exhibiting Significant Weight Gain at Day 92 |
20; 18; 16; 16; 14; 13 | — |
| SECONDARY Change in Clinical Global Impressions - Severity (CGI-S) From Baseline to Day 92 |
-0.0; -0.1; -0.0; -0.1 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 to 50 years, inclusive
- Body mass index (BMI) of 17-30 kg/m2, inclusive
- Diagnosis of schizophrenia that is clinically stable
Exclusion Criteria
- Initiated 1st antipsychotic treatment within the past 12 months and/or has had symptoms lasting <2 years
- Current diagnosis of alcohol or drug use disorder, moderate or severe
- Clinically significant or unstable medical illness, condition, or disorder
- Pregnant or breastfeeding
- Significant changes in diet or exercise regimen or plans to join a weight management program during the study
- Opioid medications taken within 14 days and/or need to take opioid medication during the study period
- History of hypersensitivity to or intolerance of olanzapine
- Use of olanzapine, clozapine, mesoridazine, chlorpromazine, or thioridazine for more than 1 week during the past year
Data sourced from ClinicalTrials.gov (NCT01903837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.