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A Study of ALKS 3831 in Adults With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01903837
Recruitment Status : Completed
First Posted : July 19, 2013
Results First Posted : September 8, 2021
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Study Description
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Brief Summary:
This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted in 2 parts. The study duration for each subject will be approximately 33 weeks and will include 25 study visits.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Samidorphan (Low Dose) Drug: Samidorphan (Medium Dose) Drug: Samidorphan (High Dose) Drug: Placebo Drug: Olanzapine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 347 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Multicenter, Safety, Tolerability, and Dose-Ranging Study of Samidorphan, a Component of ALKS 3831, in Adults With Schizophrenia Treated With Olanzapine
Study Start Date : June 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Olanzapine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Low Dose
Olanzapine + low dose samidorphan tablets taken once daily
 Drug: Samidorphan (Low Dose)
Tablets taken once daily
Other Name: Low dose samidorphan (ALKS 33)

Drug: Olanzapine
Tablets taken once daily
Experimental: Medium Dose
Olanzapine + medium dose samidorphan tablets taken once daily
 Drug: Samidorphan (Medium Dose)
Tablets taken once daily
Other Name: Medium dose samidorphan (ALKS 33)

Drug: Olanzapine
Tablets taken once daily
Experimental: High Dose
Olanzapine + high dose samidorphan tablets taken once daily
 Drug: Samidorphan (High Dose)
Tablets taken once daily
Other Name: High dose samidorphan (ALKS 33)

Drug: Olanzapine
Tablets taken once daily
Placebo Comparator: Placebo
Olanzapine + placebo tablets taken once daily
 Drug: Placebo
Tablets taken once daily

Drug: Olanzapine
Tablets taken once daily


Outcome Measures
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Primary Outcome Measures :
  1. Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score [ Time Frame: Baseline (Day 8) to Day 92 (end of study Part A) ]

    Change from baseline (Day 8) to Day 92 (end of study Part A).

    The PANSS is a 30-item scale measuring severity of schizophrenia symptoms. Symptom severity for each item is rated on a 7-point scale (1 = absent; 7 = extreme), and the total score is added together, with a minimum score of 30 and a maximum score of 210. A higher score indicates more severe symptoms, while a lower score indicates less severe symptoms.



Secondary Outcome Measures :
  1. Percent Change in Body Weight (Kilogram) From Baseline to Day 92 [ Time Frame: Baseline (Day 8) to Day 92 (end of study Part A) ]
    Percent change from baseline (Day 8) to the end of Part A (Day 92)

  2. Absolute Change in Body Weight (kg) From Baseline to Day 92 [ Time Frame: Baseline (Day 8) to Day 92 (end of study Part A) ]
    Change from randomization (Day 8) to the end of Part A (Week 12; Day 92)

  3. Percentage of Subjects Exhibiting Significant Weight Gain at Day 92 [ Time Frame: Baseline (Day 8) to Day 92 (end of study Part A) ]
    Significant weight gain will include a >=5%, >= 7%, or >=10% gain in body weight from baseline (Day 8) to Day 92 (end of study Part A)

  4. Change in Clinical Global Impressions - Severity (CGI-S) From Baseline to Day 92 [ Time Frame: Baseline (Day 8) to Day 92 (end of study Part A) ]

    Change in CGI-S score from baseline (Day 8) to the end of Part A (Week 12; Day 92).

    The CGI-S is a 7-point scale intended to measure the severity of a patient's illness at the time of assessment. Scores range from 1 (normal) to 7(extremely ill), so a higher score is correlative to more severe illness.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 50 years, inclusive
  • Body mass index (BMI) of 17-30 kg/m2, inclusive
  • Diagnosis of schizophrenia that is clinically stable

Exclusion Criteria:

  • Initiated 1st antipsychotic treatment within the past 12 months and/or has had symptoms lasting <2 years
  • Current diagnosis of alcohol or drug use disorder, moderate or severe
  • Clinically significant or unstable medical illness, condition, or disorder
  • Pregnant or breastfeeding
  • Significant changes in diet or exercise regimen or plans to join a weight management program during the study
  • Opioid medications taken within 14 days and/or need to take opioid medication during the study period
  • History of hypersensitivity to or intolerance of olanzapine
  • Use of olanzapine, clozapine, mesoridazine, chlorpromazine, or thioridazine for more than 1 week during the past year
Contacts and Locations
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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): NCT01903837


Locations
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Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: Bernard L. Silverman, MD Alkermes, Inc.
  Study Documents (Full-Text)

Documents provided by Alkermes, Inc.:
Study Protocol  [PDF] June 13, 2014
Statistical Analysis Plan  [PDF] December 2, 2014

More Information
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Publications of Results:

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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01903837    
Other Study ID Numbers: ALK3831-302
First Posted: July 19, 2013    Key Record Dates
Results First Posted: September 8, 2021
Last Update Posted: October 6, 2021
Last Verified: September 2021
Keywords provided by Alkermes, Inc.:
Schizophrenia
Olanzapine
Samidorphan
Alkermes
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Naltrexone
Olanzapine
ALKS-33
Antiemetics
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
Alcohol Deterrents
Narcotic Antagonists
Sensory System Agents