A Study of ALKS 3831 in Adults With Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 11/8/2014 |
| Start Date: | June 2013 |
| End Date: | March 2015 |
| Contact: | Laura Llewellyn |
| Phone: | 610-869-8855 |
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
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.
in 2 parts. The study duration for each subject will be approximately 33 weeks and will
include 25 study visits.
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
We found this trial at
48
sites
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