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Completed

NCT Number: NCT02694328

A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)

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

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Key information

Conditions

Schizophrenia Body Weight Mental Disorders Pathological Conditions, Signs and Symptoms Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alkermes Investigational Site, San Juan, PR, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALKS 3831

Drug

Daily dosing

Olanzapine

Drug

Daily dosing

Primary outcomes

  1. Percent Change From Baseline in Body Weight at Week 24

    Time frame: Baseline and Week 24

  2. Percentage of Participants With >/= 10% Weight Gain at Week 24

    Time frame: Baseline and Week 24

Secondary outcomes

  1. Percentage of Participants With >/= 7% Weight Gain at Week 24

    Time frame: Baseline and Week 24

  2. Number of Participants Experiencing of Adverse Events (AEs)

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults With Schizophrenia

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 29, 2016
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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