NCT02694328CompletedPhase 3
A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults With Schizophrenia
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Alkermes, Inc.
- Enrollment
- 561
- Locations
- 1
- Primary Endpoint
- Percent Change From Baseline in Body Weight at Week 24
Study Overview
Brief Summary
This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject has a body mass index (BMI) of 18.0-30.0 kg/m^2, inclusive, at Visit 1 and Visit 2
- •Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia
- •Subject is appropriate for outpatient treatment; has no hospitalizations for acute exacerbations of schizophrenia within 6 months before Visit 1
- •Subject has maintained a stable body weight (change </= 5%) for at least 3 months prior to Visit 1 based on self-report
- •Additional criteria may apply
Exclusion Criteria
- •Subject has any of the following psychiatric conditions per DSM-5 criteria:
- •Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder
- •Clinically significant cognitive difficulties present within the past 2 years that could interfere with participation in the study
- •Drug-induced or toxic psychosis
- •Any other psychiatric condition that could interfere with participation in the study
- •Subject poses a current suicide risk at Visit 1 or Visit 2 in the opinion of the investigator
- •Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder
- •Additional criteria may apply
Arms & Interventions
ALKS 3831
Experimental
Administered as a coated bilayer tablet
Intervention: ALKS 3831 (Drug)
Olanzapine
Active Comparator
Administered as a coated bilayer tablet
Intervention: Olanzapine (Drug)
Outcomes
Primary Outcomes
Percent Change From Baseline in Body Weight at Week 24
Time Frame: Baseline and Week 24
Percentage of Participants With >/= 10% Weight Gain at Week 24
Time Frame: Baseline and Week 24
Secondary Outcomes
- Percentage of Participants With >/= 7% Weight Gain at Week 24(Baseline and Week 24)
- Number of Participants Experiencing of Adverse Events (AEs)(24 weeks)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
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 DisorderSchizophreniform DisordersSchizophreniaBipolar I DisorderNCT03187769Alkermes, Inc.426
Completed
Phase 3
A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)SchizophreniaNCT02634346Alkermes, Inc.403
Completed
Phase 4
A Study on Induced Weight Gain During Atypical Antipsychotic Treatment and Its Management With Psychoeducational ProgrammeWeight GainNCT00191828Eli Lilly and Company60
Completed
Phase 2
ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol DependenceAlcohol DependenceNCT00981617Alkermes, Inc.406
Recruiting
Phase 3
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I DisorderSchizophreniaBipolar I DisorderNCT05303064Alkermes, Inc.220