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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

This study is currently recruiting participants.
Verified October 2017 by Alkermes, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03187769
First Posted: June 15, 2017
Last Update Posted: October 25, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Alkermes, Inc.
June 8, 2017
June 15, 2017
October 25, 2017
June 8, 2017
January 2019   (Final data collection date for primary outcome measure)
Percent change from baseline in body weight [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT03187769 on ClinicalTrials.gov Archive Site
  • Proportion of subjects with ≥10% weight gain [ Time Frame: 12 weeks ]
  • Proportion of subjects with ≥7% weight gain at week 12 [ Time Frame: 12 weeks ]
  • Safety will be measured by frequency of serious and non-serious adverse events [ Time Frame: Up to 16 weeks ]
  • Proportion of subjects with >10% weight gain [ Time Frame: 12 weeks ]
  • Proportion of subjects with >7% weight gain at week 12 [ Time Frame: 12 weeks ]
  • Safety will be measured by frequency of serious and non-serious adverse events [ Time Frame: Up to 16 weeks ]
Not Provided
Not Provided
 
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
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
In the US adolescent subjects starting at age 16 will be enrolled. In the EU, subjects age 18 and older will be enrolled.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizophreniform Disorders
  • Bipolar I Disorder
  • Drug: ALKS 3831
    Olanzapine + samidorphan, daily oral dosing
  • Drug: Olanzapine
    Daily oral dosing
  • Experimental: ALKS 3831
    Coated bilayer tablet
    Intervention: Drug: ALKS 3831
  • Active Comparator: Olanzapine
    Coated bilayer tablet
    Intervention: Drug: Olanzapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
February 2019
January 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has less than 10 weeks previous treatment with antipsychotics (cumulative; lifetime)
  • Has less than 4 years elapse since the initial onset of active-phase of symptoms
  • Have a body mass index (BMI) of 18.0 to ≤ 27.0 kg/m^2
  • Agrees to use an acceptable method of contraception for the duration of the study
  • Subject meets the criteria for a primary diagnosis of schizophrenia, schizophreniform disorder, or bipolar I disorder
  • For bipolar I disorder, must be currently experiencing an episode of acute mania
  • 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 or has received treatment with electroconvulsive therapy in their lifetime
  • Currently treated with mood stabilizers (eg lithium, valproate)
  • 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
Sexes Eligible for Study: All
16 Years to 40 Years   (Child, Adult)
No
Contact: Kimberly Myer 215-636-9745 Kimberly.Myer@premier-research.com
United States
 
 
NCT03187769
ALK3831-A307
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Alkermes, Inc.
Alkermes, Inc.
Not Provided
Study Director: David McDonnell, MD Alkermes, Inc.
Alkermes, Inc.
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP