Schizophrenia Clinical Trial
Official title:
A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults With Schizophrenia
Verified date | January 2020 |
Source | Alkermes, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.
Status | Completed |
Enrollment | 561 |
Est. completion date | November 7, 2018 |
Est. primary completion date | November 7, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Subject has a body mass index (BMI) of 18.0-30.0 kg/m^2, inclusive, at Visit 1 and Visit 2 - Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia - Subject is appropriate for outpatient treatment; has no hospitalizations for acute exacerbations of schizophrenia within 6 months before Visit 1 - Subject has maintained a stable body weight (change </= 5%) for at least 3 months prior to Visit 1 based on self-report - Additional criteria may apply Exclusion Criteria: - Subject has any of the following psychiatric conditions per DSM-5 criteria: - Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder - Clinically significant cognitive difficulties present within the past 2 years that could interfere with participation in the study - Drug-induced or toxic psychosis - Any other psychiatric condition that could interfere with participation in the study - Subject poses a current suicide risk at Visit 1 or Visit 2 in the opinion of the investigator - Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder - Additional criteria may apply |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Alkermes Investigational Site | San Juan | |
Puerto Rico | Alkermes Investigational Site | San Juan | |
United States | Alkermes Investigational Site | Allentown | Pennsylvania |
United States | Alkermes Investigational Site | Anaheim | California |
United States | Alkermes Investigational Site | Atlanta | Georgia |
United States | Alkermes Investigational Site | Augusta | Georgia |
United States | Alkermes Investigational Site | Austin | Texas |
United States | Alkermes Investigational Site | Austin | Texas |
United States | Alkermes Investigational Site | Bellevue | Washington |
United States | Alkermes Investigational Site | Berlin | New Jersey |
United States | Alkermes Investigational Site | Brooklyn | New York |
United States | Alkermes Investigational Site | Canton | Ohio |
United States | Alkermes Investigational Site | Cerritos | California |
United States | Alkermes Investigational Site | Chicago | Illinois |
United States | Alkermes Investigational Site | Creve Coeur | Missouri |
United States | Alkermes Investigational Site | Culver City | California |
United States | Alkermes Investigational Site | Dallas | Texas |
United States | Alkermes Investigational Site | Dayton | Ohio |
United States | Alkermes Investigational Site | Decatur | Georgia |
United States | Alkermes Investigational Site | DeSoto | Texas |
United States | Alkermes Investigational Site | Flowood | Mississippi |
United States | Alkermes Investigational Site | Garden Grove | California |
United States | Alkermes Investigational Site | Glendale | California |
United States | Alkermes Investigational Site | Grand Rapids | Michigan |
United States | Alkermes Investigational Site | Houston | Texas |
United States | Alkermes Investigational Site | Jamaica | New York |
United States | Alkermes Investigational Site | Las Vegas | Nevada |
United States | Alkermes Investigational Site | Lauderhill | Florida |
United States | Alkermes Investigational Site | Little Rock | Arkansas |
United States | Alkermes Investigational Site | Long Beach | California |
United States | Alkermes Investigational Site | Marlton | New Jersey |
United States | Alkermes Investigational Site | Miami | Florida |
United States | Alkermes Investigational Site | Middleburg Heights | Ohio |
United States | Alkermes Investigational Site | National City | California |
United States | Alkermes Investigational Site | New York | New York |
United States | Alkermes Investigational Site | New York | New York |
United States | Alkermes Investigational Site | North Miami | Florida |
United States | Alkermes Investigational Site | O'Fallon | Missouri |
United States | Alkermes Investigational Site | Oakland | California |
United States | Alkermes Investigational Site | Oakland Park | Florida |
United States | Alkermes Investigational Site | Oceanside | California |
United States | Alkermes Investigational Site | Orange | California |
United States | Alkermes Investigational Site | Pico Rivera | California |
United States | Alkermes Investigational Site | Redlands | California |
United States | Alkermes Investigational Site | Rochester | New York |
United States | Alkermes Investigational Site | Saint Louis | Missouri |
United States | Alkermes Investigational Site | San Diego | California |
United States | Alkermes Investigational Site | San Diego | California |
United States | Alkermes Investigational Site | Springdale | Arkansas |
United States | Alkermes Investigational Site | Tampa | Florida |
United States | Alkermes Investigational Site | Temecula | California |
United States | Alkermes Investigational Site | Torrance | California |
United States | Alkermes Investigational Site | Wards Island | New York |
United States | Alkermes Investigational Site | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Alkermes, Inc. |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Change From Baseline in Body Weight at Week 24 | Baseline and Week 24 | ||
Primary | Percentage of Participants With >/= 10% Weight Gain at Week 24 | Baseline and Week 24 | ||
Secondary | Percentage of Participants With >/= 7% Weight Gain at Week 24 | Baseline and Week 24 | ||
Secondary | Number of Participants Experiencing of Adverse Events (AEs) | 24 weeks |
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