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History of Changes for Study: NCT03187769
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
Latest version (submitted January 5, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 13, 2017 None (earliest Version on record)
2 August 16, 2017 Study Status and Contacts/Locations
3 October 24, 2017 Study Status, Contacts/Locations, Eligibility and Outcome Measures
4 December 20, 2017 Study Status and Contacts/Locations
5 March 5, 2018 Study Status, Contacts/Locations and Eligibility
6 July 26, 2018 Contacts/Locations and Study Status
7 August 15, 2018 Study Status
8 January 18, 2019 Contacts/Locations and Study Status
9 March 7, 2019 Study Status and Contacts/Locations
10 May 7, 2019 Contacts/Locations and Study Status
11 July 26, 2019 Study Status, Outcome Measures, Contacts/Locations, Eligibility and Study Design
12 May 14, 2020 Contacts/Locations and Study Status
13 October 19, 2020 Contacts/Locations and Study Status
14 December 18, 2020 Contacts/Locations and Study Status
15 March 31, 2021 Study Status and Contacts/Locations
16 May 3, 2021 Contacts/Locations and Study Status
17 July 8, 2021 Contacts/Locations and Study Status
18 August 20, 2021 Recruitment Status, Study Status and Contacts/Locations
19 September 30, 2021 Study Status
20 January 5, 2022 Recruitment Status, Study Status and Study Design
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Study NCT03187769
Submitted Date:  June 13, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: ALK3831-A307
Brief Title: 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: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2017
Overall Status: Recruiting
Study Start: June 8, 2017
Primary Completion: January 2019 [Anticipated]
Study Completion: February 2019 [Anticipated]
First Submitted: June 8, 2017
First Submitted that
Met QC Criteria:
June 13, 2017
First Posted: June 15, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
June 13, 2017
Last Update Posted: June 15, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Alkermes, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Schizophrenia
Schizophreniform Disorders
Bipolar I Disorder
Keywords: Alkermes
ALKS 3831
Olanzapine
Samidorphan
Schizophrenia
Schizophreniform
Bipolar I
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 250 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percent change from baseline in body weight
[ Time Frame: 12 weeks ]

Secondary Outcome Measures:
1. Proportion of subjects with >10% weight gain
[ 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 ]

Open or close this module Eligibility
Minimum Age: 16 Years
Maximum Age: 40 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Kimberly Myer
Telephone: 215-636-9745
Email: Kimberly.Myer@premier-research.com
Study Officials: David McDonnell, MD
Study Director
Alkermes, Inc.
Locations: United States, Illinois
Alkermes Investigational Site
[Recruiting]
Chicago, Illinois, United States, 60611
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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