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Completed

NCT Number: NCT01903837

A Study of ALKS 3831 in Adults With Schizophrenia

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alkermes Investigational Site, Burgas, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Samidorphan (Low Dose)

Drug

Tablets taken once daily

Other names: Low dose samidorphan (ALKS 33)

Samidorphan (Medium Dose)

Drug

Tablets taken once daily

Other names: Medium dose samidorphan (ALKS 33)

Samidorphan (High Dose)

Drug

Tablets taken once daily

Other names: High dose samidorphan (ALKS 33)

Placebo

Drug

Tablets taken once daily

Olanzapine

Drug

Tablets taken once daily

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jul 19, 2013
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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