Trials Sponsors Conditions Drugs Pricing

Conditions

Schizophrenia

Keywords

SchizophreniaOlanzapineSamidorphanAlkermes

Outcome Measures

Primary Outcomes (1)

Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score
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.
Baseline (Day 8) to Day 92 (end of study Part A)

Secondary Outcomes (4)

Percent Change in Body Weight (Kilogram) From Baseline to Day 92
Baseline (Day 8) to Day 92 (end of study Part A)
Absolute Change in Body Weight (kg) From Baseline to Day 92
Baseline (Day 8) to Day 92 (end of study Part A)
Percentage of Subjects Exhibiting Significant Weight Gain at Day 92
Baseline (Day 8) to Day 92 (end of study Part A)
Change in Clinical Global Impressions - Severity (CGI-S) From Baseline to Day 92
Baseline (Day 8) to Day 92 (end of study Part A)

Study Arms (4)

Low Dose

EXPERIMENTAL

Olanzapine + low dose samidorphan tablets taken once daily

Drug: Samidorphan (Low Dose)Drug: Olanzapine

Medium Dose

EXPERIMENTAL

Olanzapine + medium dose samidorphan tablets taken once daily

Drug: Samidorphan (Medium Dose)Drug: Olanzapine

High Dose

EXPERIMENTAL

Interventions

Samidorphan (Low Dose)Drug

Tablets taken once daily

Also known as: Low dose samidorphan (ALKS 33)

Low Dose

Samidorphan (Medium Dose)Drug

Tablets taken once daily

Also known as: Medium dose samidorphan (ALKS 33)

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Age 18 to 50 years, inclusive
Body mass index (BMI) of 17-30 kg/m2, inclusive

Sponsors & Collaborators

Alkermes, Inc.
Industrylead

Study Sites (61)

Alkermes Investigational Site

Little Rock, Arkansas, 72211, United States

Alkermes Investigational Site

Anaheim, California, 92805, United States

Alkermes Investigational Site

Costa Mesa, California, 92626, United States

Alkermes Investigational Site

Culver City, California, 90230, United States

Alkermes Investigational Site

Escondido, California, 92025, United States

Alkermes Investigational Site

Garden Grove, California, 92845, United States

Alkermes Investigational Site

National City, California, 91950, United States

Related Publications (1)

Martin WF, Correll CU, Weiden PJ, Jiang Y, Pathak S, DiPetrillo L, Silverman BL, Ehrich EW. Mitigation of Olanzapine-Induced Weight Gain With Samidorphan, an Opioid Antagonist: A Randomized Double-Blind Phase 2 Study in Patients With Schizophrenia. Am J Psychiatry. 2019 Jun 1;176(6):457-467. doi: 10.1176/appi.ajp.2018.18030280. Epub 2019 Mar 8.
PMID: 30845818RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

3-carboxamido-4-hydroxynaltrexoneOlanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title: Director, Corporate and R&D Communications
Organization: Alkermes

Study Officials

Bernard L. Silverman, MD
Alkermes, Inc.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

347 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 5, 2013

First Posted

July 19, 2013

Study Start

June 2013

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (4)

Low Dose

Medium Dose

High Dose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (61)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Placebo

You may not qualify if:

Source record

Documents

Locations