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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

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ClinicalTrials.gov Identifier: NCT03187769
Recruitment Status : Completed
First Posted : June 15, 2017
Last Update Posted : January 10, 2022
Information provided by (Responsible Party):
Alkermes, Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Schizophrenia Schizophreniform Disorders Bipolar I Disorder Drug: ALKS 3831 Drug: Olanzapine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 8, 2017
Actual Primary Completion Date : December 1, 2021
Actual Study Completion Date : January 3, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ALKS 3831
Coated bilayer tablet
Drug: ALKS 3831
Olanzapine + samidorphan, daily oral dosing

Active Comparator: Olanzapine
Coated bilayer tablet
Drug: Olanzapine
Daily oral dosing

Primary Outcome Measures :
  1. Percent change from baseline in body weight at Week 12 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects with ≥10% weight gain at Week 12 [ Time Frame: 12 weeks ]
  2. Proportion of subjects with ≥7% weight gain at Week 12 [ Time Frame: 12 weeks ]
  3. Safety will be measured by frequency of serious and non-serious adverse events [ Time Frame: Up to 16 weeks ]
  4. Change from baseline in waist circumference at Week 12 [ Time Frame: Baseline and Week 12 ]
  5. Change from baseline in Clinical Global Impression-Severity (CGI-S) score within the ALKS 3831 Group at Week 12 [ Time Frame: Baseline and Week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • Has a history of diabetes
  • Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
  • 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 ClinicalTrials.gov identifier (NCT number): NCT03187769

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Sponsors and Collaborators
Alkermes, Inc.
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Study Director: Alkermes Medical Director Alkermes, Inc.
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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT03187769    
Other Study ID Numbers: ALK3831-A307
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: January 10, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alkermes, Inc.:
ALKS 3831
Bipolar I
Additional relevant MeSH terms:
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Body Weight
Psychotic Disorders
Pathologic Processes
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