A Phase 3 study to evaluate weight gain of investigational medication compared to olanzapine in adults with schizophrenia

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  • sponsor
    Alkermes Inc.
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Updated on 23 November 2020
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Summary

A Phase 3 study to evaluate weight gain of investigational medication compared to olanzapine in adults with schizophrenia

Description

This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.

All study-related exams, tests, procedures and medication will be provided free of charge. Reasonable compensation for time and travel may be provided.

Details
Clinical Study IdentifierTX145489
SponsorAlkermes Inc.
Last Modified on23 November 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 55 yrs?
Gender: Male or Female
Subject has a body mass index (BMI) of 18.0-30.0 kg/m2, 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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