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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 | Clinical Trials | Clareo Health

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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

A Study to 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

NCT03187769•Alkermes, Inc.

View on ClinicalTrials.gov

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

Detailed Description

In the US adolescent subjects starting at age 16 will be enrolled. In the EU, subjects age 18 and older will be enrolled.

Eligibility

Age

16 - 40 years

Sex

ALL

Healthy Volunteers

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 \<30 kg/m\^2
•Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after the last dose of study drug
•Subject meets the criteria for a primary diagnosis of schizophrenia, schizophreniform disorder, or bipolar I disorder
•For bipolar I disorder, must have been experiencing an episode of acute mania within ≤14 days prior to Visit 1
•Suitable for outpatient treatment
•Additional criteria may apply

Exclusion Criteria

•Poses a current suicide risk
•Has a history of poor or inadequate response to treatment with olanzapine
•Has previously been treated with long-acting injectable antipsychotic medication within the 2 months prior to screening, or has \> 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
+3 more criteria

Locations (57)

Alkermes Investigational Site

Little Rock, Arkansas, United States

Alkermes Investigational Site

Rogers, Arkansas, United States

Alkermes Investigational Site

Garden Grove, California, United States

Alkermes Investigational Site

San Diego, California, United States

Alkermes Investigational Site

Stanford, California, United States

Alkermes Investigational Site

Jacksonville, Florida, United States

Alkermes Investigational Site

North Miami, Florida, United States

Alkermes Investigational Site

Atlanta, Georgia, United States

Alkermes Investigational Site

Atlanta, Georgia, United States

Alkermes Investigational Site

Augusta, Georgia, United States

Key Dates

Start Date

June 8, 2017

Primary Completion Date

December 1, 2021

Completion Date

January 3, 2022

Last Updated

January 19, 2023

Enrollment

426

ACTUAL participants

Conditions

SchizophreniaSchizophreniform DisordersBipolar I Disorder

Interventions

ALKS 3831

DRUG

Olanzapine

DRUG

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NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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