Phase 3
Completed N=426
Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder
Schizophrenia · Schizophreniform Disorders · Bipolar I Disorder
Source: ClinicalTrials.gov NCT03187769 ↗
Enrolled (actual)
426
Serious AEs
3.8%
Results posted
Jan 2023
Primary outcomePrimary: Percent Change From Baseline in Body Weight at Week 12 — 4.91; 6.77 Percentage of change in body weight — p=.012
◆ Published Evidence
Emerging
15citations · ~5 / year
Olanzapine/Samidorphan in Young Adults With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder Who Are Early in Their Illness: Results of the Randomized, Controlled ENLIGHTEN-Early Study.
Summary
This study will evaluate the effect of ALKS 3831 compared to olanzapine on body weight in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness
Linked Publications
-
Olanzapine/Samidorphan in Young Adults With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder Who Are Early in Their Illness: Results of the Randomized, Controlled ENLIGHTEN-Early Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Body Weight at Week 12 |
4.91; 6.77 | .012 sig |
| SECONDARY Percentage of Subjects With ≥10% Weight Gain at Week 12 |
21.9; 30.4 | — |
| SECONDARY Percentage of Subjects With ≥7% Weight Gain at Week 12 |
33.1; 44.8 | — |
| SECONDARY Number of Participants Experiencing of Adverse Events (AEs) |
134; 136 | — |
| SECONDARY Change From Baseline in Waist Circumference at Week 12 |
2.99; 3.90 | — |
| SECONDARY Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score Within the ALKS 3831 Group at Week 12 |
-.82 | — |
Eligibility Criteria
Inclusion Criteria
- Has less than 24 weeks previous treatment with antipsychotics (cumulative; lifetime)
- Subject treated with aripiprazole can receive an additional 1 year of treatment at ≤5 mg/day, and this treatment will not be considered as part of the 24 weeks of previous treatment with antipsychotics
- Has less than 4 years elapse since the initial onset of active-phase of symptoms
- Has a body mass index (BMI) of 6 months cumulative life use, or has received treatment with electroconvulsive therapy in their lifetime
- Has initiated treatment with mood stabilizers (eg lithium, valproate, etc) >2 months prior to Visit 1
- Has a positive drug screen for opioids, phencyclidine (PCP), amphetamine/methamphetamine, or cocaine
- Has taken opioid agonists (eg, codeine, oxycodone, tramadol, morphine) within the 14 days prior to Visit 1, or has taken opioid antagonists, including naltrexone and naloxone, within 60 days prior to Visit 1
- Taking any weight loss agents or hypoglycemic agents
- Has a clinically significant or unstable medical illness, condition, or disorder that would be anticipated to potentially compromise subject safety or adversely affect the evaluation of efficacy
- Has joined a weight management program or had significant changes in diet or exercise regimen within the past 6 weeks
- Has started a smoking cessation program within the past 6 months
- Has a history of diabetes
- Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
- Additional criteria may apply
Data sourced from ClinicalTrials.gov (NCT03187769) and the linked publication. 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.