Clinical trial NCT02694328: A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)
Official title: A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Alkermes
ALKS 3831
Samidorphan
Schizophrenia
Olanzapine
Weight
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-29
Enrollment: 561
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.


Eligibility criteria: 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

Primary outcomes:
measure: Percent Change From Baseline in Body Weight at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With >/= 10% Weight Gain at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Percentage of Participants With >/= 7% Weight Gain at Week 24
timeFrame: Baseline and Week 24
measure: Number of Participants Experiencing of Adverse Events (AEs)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Springdale
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Alkermes Investigational Site
state: California
city: Cerritos
country: United States
facility: Alkermes Investigational Site
state: California
city: Culver City
country: United States
facility: Alkermes Investigational Site
state: California
city: Garden Grove
country: United States
facility: Alkermes Investigational Site
state: California
city: Glendale
country: United States
facility: Alkermes Investigational Site
state: California
city: Long Beach
country: United States
facility: Alkermes Investigational Site
state: California
city: National City
country: United States
facility: Alkermes Investigational Site
state: California
city: Oakland
country: United States
facility: Alkermes Investigational Site
state: California
city: Oceanside
country: United States
facility: Alkermes Investigational Site
state: California
city: Orange
country: United States
facility: Alkermes Investigational Site
state: California
city: Pico Rivera
country: United States
facility: Alkermes Investigational Site
state: California
city: Redlands
country: United States
facility: Alkermes Investigational Site
state: California
city: San Diego
country: United States
facility: Alkermes Investigational Site
state: California
city: San Diego
country: United States
facility: Alkermes Investigational Site
state: California
city: Temecula
country: United States
facility: Alkermes Investigational Site
state: California
city: Torrance
country: United States
facility: Alkermes Investigational Site
state: California
city: Washington
country: United States
facility: Alkermes Investigational Site
state: District of Columbia
city: Lauderhill
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Miami
country: United States
facility: Alkermes Investigational Site
state: Florida
city: North Miami
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Oakland Park
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Tampa
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Augusta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Grand Rapids
country: United States
facility: Alkermes Investigational Site
state: Michigan
city: Flowood
country: United States
facility: Alkermes Investigational Site
state: Mississippi
city: Creve Coeur
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: O'Fallon
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Alkermes Investigational Site
state: Nevada
city: Berlin
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Marlton
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: Alkermes Investigational Site
state: New York
city: Jamaica
country: United States
facility: Alkermes Investigational Site
state: New York
city: New York
country: United States
facility: Alkermes Investigational Site
state: New York
city: New York
country: United States
facility: Alkermes Investigational Site
state: New York
city: Rochester
country: United States
facility: Alkermes Investigational Site
state: New York
city: Wards Island
country: United States
facility: Alkermes Investigational Site
state: New York
city: Canton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Middleburg Heights
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Allentown
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Dallas
country: United States
facility: Alkermes Investigational Site
state: Texas
city: DeSoto
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Houston
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Bellevue
country: United States
facility: Alkermes Investigational Site
state: Washington
city: San Juan
country: Puerto Rico
facility: Alkermes Investigational Site
city: San Juan
country: Puerto Rico
facility: Alkermes Investigational Site
Study officials:
affiliation: Alkermes, Inc.
name: Alkermes Medical Director
role: STUDY_DIRECTOR
References:
citation: Correll CU, Stein E, Graham C, DiPetrillo L, Akerman S, Stanford AD, Jiang Y, Yagoda S, McDonnell D, Hopkinson C. Reduction in Multiple Cardiometabolic Risk Factors With Combined Olanzapine/Samidorphan Compared With Olanzapine: Post Hoc Analyses From a 24-Week Phase 3 Study. Schizophr Bull. 2023 Mar 15;49(2):454-463. doi: 10.1093/schbul/sbac144.