Study to evaluate the efficacy and safety of ALKS 3831 in adult patients who have an acute exacerbation of Schizophrenia

Phase 1

• Conditions: Schizophrenia; MedDRA version: 19.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2015-003373-15-BG
• Lead Sponsor: Alkermes Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

Each subject must meet all of the following inclusion criteria to be qualified to participate in this study.
Is age 18–70 years, inclusive, at screening
Has a body mass index (BMI) of 18.0–40.0 kg/m2, inclusive at screening
Meets criteria for the diagnosis of schizophrenia.
Resides in a stable living situation when not hospitalized
Is willing and able to provide government-issued identification
Additional criteria may apply

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 370
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Has had a psychiatric hospitalization for more than 30 days during the 90 days before screening
Subject initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase of schizophrenia symptoms
Subject poses a current suicide risk
Subject has a history of treatment resistance
Subject has a history of poor or inadequate response to treatment with olanzapine
Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-month period prior to screening
Subject has a diagnosis of moderate or severe alcohol or drug use disorder
Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine, phencyclidine, or cocaine at screening
Additional criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate the antipsychotic efficacy of ALKS 3831(a fixed-dose combination of olanzapine and samidorphan) in adult subjects with an acute exacerbation of schizophrenia;Secondary Objective: The secondary objective of this study is to evaluate the safety and tolerability of ALKS 3831 in adult subjects with an acute exacerbation of schizophrenia;Primary end point(s): The primary efficacy endpoint is change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 4.;Timepoint(s) of evaluation of this end point: Baseline and week 4, also assessed throughout at weeks 1, 2 and 3

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The key secondary efficacy endpoint is change from baseline in Modified Overt Aggression Scale (MOAS) total score at Week 2;Timepoint(s) of evaluation of this end point: Baseline and week 2, also assessed at week 1