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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02694328
Recruitment Status : Active, not recruiting
First Posted : February 29, 2016
Last Update Posted : October 31, 2018
Information provided by (Responsible Party):
Alkermes, Inc.

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: ALKS 3831 Drug: Olanzapine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 561 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults With Schizophrenia
Study Start Date : February 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ALKS 3831
Administered as a coated bilayer tablet
Drug: ALKS 3831
Daily dosing

Active Comparator: Olanzapine
Administered as a coated bilayer tablet
Drug: Olanzapine
Daily dosing

Primary Outcome Measures :
  1. Percent change from baseline in body weight [ Time Frame: 24 weeks ]
  2. Proportion of subjects with >/= 10% weight gain [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects with >/= 7% weight gain [ Time Frame: 24 weeks ]
  2. Incidence of Adverse Events (AEs) [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02694328

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Sponsors and Collaborators
Alkermes, Inc.
Study Director: Alkermes Medical Director Alkermes, Inc.

Responsible Party: Alkermes, Inc. Identifier: NCT02694328     History of Changes
Other Study ID Numbers: ALK3831-A303
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alkermes, Inc.:
ALKS 3831

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents