A Study of ALKS 3831 in Adults With Schizophrenia

Alkermes

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Olanzapine; Drug: Placebo; Drug: Samidorphan (High Dose); Drug: Samidorphan (Low Dose); Drug: Samidorphan (Medium Dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01903837

ALK3831-302

Details and patient eligibility

About

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.

Enrollment: 347 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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347 participants in 4 patient groups, including a placebo group

Low Dose

Experimental group

Description:

Olanzapine + low dose samidorphan tablets taken once daily

Treatment:

Drug: Samidorphan (Low Dose)

Drug: Olanzapine

Medium Dose

Experimental group

Description:

Olanzapine + medium dose samidorphan tablets taken once daily

Treatment:

Drug: Samidorphan (Medium Dose)

Drug: Olanzapine

High Dose

Experimental group

Description:

Olanzapine + high dose samidorphan tablets taken once daily

Treatment:

Drug: Olanzapine

Drug: Samidorphan (High Dose)

Placebo

Placebo Comparator group

Description:

Olanzapine + placebo tablets taken once daily

Treatment:

Drug: Olanzapine

Drug: Placebo