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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 : Recruiting
First Posted : June 15, 2017
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Tracking Information
First Submitted Date  ICMJE June 8, 2017
First Posted Date  ICMJE June 15, 2017
Last Update Posted Date July 29, 2019
Actual Study Start Date  ICMJE June 8, 2017
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2019)
Percent change from baseline in body weight at Week 12 [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
Percent change from baseline in body weight [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT03187769 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2019)
  • Proportion of subjects with ≥10% weight gain at Week 12 [ 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 ]
  • Change from baseline in waist circumference at Week 12 [ Time Frame: Baseline and Week 12 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizophreniform Disorders
  • Bipolar I Disorder
Intervention  ICMJE
  • Drug: ALKS 3831
    Olanzapine + samidorphan, daily oral dosing
  • Drug: Olanzapine
    Daily oral dosing
Study Arms  ICMJE
  • Experimental: ALKS 3831
    Coated bilayer tablet
    Intervention: Drug: ALKS 3831
  • Active Comparator: Olanzapine
    Coated bilayer tablet
    Intervention: Drug: Olanzapine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 26, 2019)
425
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2017)
250
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Premier Research 1-860-200-6465 ALK3831A307CT@premier-research.com
Listed Location Countries  ICMJE Austria,   Germany,   Ireland,   Israel,   Italy,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03187769
Other Study ID Numbers  ICMJE ALK3831-A307
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alkermes, Inc.
Study Sponsor  ICMJE Alkermes, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alkermes Medical Director Alkermes, Inc.
PRS Account Alkermes, Inc.
Verification Date July 2019

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