Clinical trial NCT01903837: A Study of ALKS 3831 in Adults With Schizophrenia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Olanzapine
Samidorphan
Alkermes
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-19
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score
timeFrame: Baseline (Day 8) to Day 92 (end of study Part A)
Secondary outcomes:
measure: Percent Change in Body Weight (Kilogram) From Baseline to Day 92
timeFrame: Baseline (Day 8) to Day 92 (end of study Part A)
measure: Absolute Change in Body Weight (kg) From Baseline to Day 92
timeFrame: Baseline (Day 8) to Day 92 (end of study Part A)
measure: Percentage of Subjects Exhibiting Significant Weight Gain at Day 92
timeFrame: Baseline (Day 8) to Day 92 (end of study Part A)
measure: Change in Clinical Global Impressions - Severity (CGI-S) From Baseline to Day 92
timeFrame: Baseline (Day 8) to Day 92 (end of study Part A)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Alkermes Investigational Site
state: California
city: Costa Mesa
country: United States
facility: Alkermes Investigational Site
state: California
city: Culver City
country: United States
facility: Alkermes Investigational Site
state: California
city: Escondido
country: United States
facility: Alkermes Investigational Site
state: California
city: Garden Grove
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: San Diego
country: United States
facility: Alkermes Investigational Site
state: California
city: Torrance
country: United States
facility: Alkermes Investigational Site
state: California
city: New Britain
country: United States
facility: Alkermes Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Alkermes Investigational Site
state: District of Columbia
city: Bradenton
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Leesburg
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Oakland Park
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Orlando
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Atlanta
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: Lake Charles
country: United States
facility: Alkermes Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Alkermes Investigational Site
state: Louisiana
city: Rockville
country: United States
facility: Alkermes Investigational Site
state: Maryland
city: Flowood
country: United States
facility: Alkermes Investigational Site
state: Mississippi
city: Creve Coeur
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Marlton
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Neptune
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Canton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Mason
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Alkermes Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Alkermes Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Alkermes Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Alkermes Investigational Site
state: Tennessee
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: 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: Houston
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Alkermes Investigational Site
state: Utah
city: Bellevue
country: United States
facility: Alkermes Investigational Site
state: Washington
city: Richland
country: United States
facility: Alkermes Investigational Site
state: Washington
city: Burgas
country: Bulgaria
facility: Alkermes Investigational Site
city: Kazanlak
country: Bulgaria
facility: Alkermes Investigational Site
city: Lovech
country: Bulgaria
facility: Alkermes Investigational Site
city: Novi Iskar
country: Bulgaria
facility: Alkermes Investigational Site
city: Pazardzhik
country: Bulgaria
facility: Alkermes Investigational Site
city: Sofia
country: Bulgaria
facility: Alkermes Investigational Site
city: Tserova Koria
country: Bulgaria
facility: Alkermes Investigational Site
city: Varna
country: Bulgaria
facility: Alkermes Investigational Site
city: Vratsa
country: Bulgaria
facility: Alkermes Investigational Site
city: Brno-mesto
country: Czechia
facility: Alkermes Investigational Site
city: Praha
country: Czechia
facility: Alkermes Investigational Site
Study officials:
affiliation: Alkermes, Inc.
name: Bernard L. Silverman, MD
role: STUDY_DIRECTOR
References:
citation: 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.