A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)

Phase 3CompletedNCT01192867

Hoffmann-La Roche629 enrolled

Overview

This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in participants with persistent, predominant negative symptoms of schizophrenia. Participants, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 56 weeks (treatment period 1 of 24 weeks and treatment period 2 of 32 weeks), followed by an optional treatment extension for up to 3 years. After 52 weeks, participants who were originally randomized to an active treatment will be randomly assigned to receive either placebo or continue on the originally assigned study treatment for 4 weeks washout period (Week 52 to Week 56) for the assessment of potential withdrawal effects in a blinded manner using participants staying on active treatment as a control. Participants initially randomized to placebo will remain on placebo. After 56 weeks, participants who were switched to placebo in the washout period will return to their blinded, active treatment arm.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

629

Conditions

Schizophrenia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype * Predominant negative symptoms * With the exception of clozapine, participants are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics) Exclusion Criteria: * Evidence that participant has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder) * Body Mass Index (BMI) of less than (\<) 17 or greater than (\>) 40 kilograms per meter square (kg/m\^2) * Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS) * A severity score of 3 or greater on the Parkinsonism item of the Exrapyramidal Symptoms Rating Scale-Abbreviated (ESRS-A) (Clinical Global Impression, Parkinsonism)

Locations (122)

K&S Professional Research Services LLC

Little Rock, Arkansas, United States

Advanced Research Center Inc.

Anaheim, California, United States

Comprehensive Clinical Development- Cerritos CA

Cerritos, California, United States

Diligent Clinical Trials Inc

Downey, California, United States

Care Research Center

La Palma, California, United States

Outcomes

Primary Outcomes

Change From Baseline in the Positive and Negative Symptoms Scales (PANSS) Negative Symptoms Factor Score at Week 24 (All-Participant Population)

Time frame: Baseline, Week 24

Percentage of Participants With Adverse Events (All-Participant Population)

Time frame: Week 24

Secondary Outcomes

Change From Baseline in the PANSS Negative Symptoms Factor Score at Week 24 (Complement Factor H Related Protein 1 High [CFHR1-High] Subgroup Population)

Time frame: Baseline, Week 24

Change From Baseline in the Personal and Social Performance (PSP) Total Score at Week 24 (All-Participant Population)

Time frame: Baseline, Week 24

Change From Baseline in the PSP Total Score at Week 24 (CFHR1-High Subgroup Population)

Time frame: Baseline, Week 24

Change From Baseline in the PANSS Total Score at Week 24 (All-Participant Population)

Time frame: Baseline, Week 24

Change From Baseline in the PANSS Total Score at Week 24 (CFHR1-High Subgroup Population)

Time frame: Baseline, Week 24

Change From Baseline in the PANSS Factor Score at Week 24 (All-Participant Population)

Time frame: Baseline, Week 24

Change From Baseline in the PANSS Factor Score at Week 24 (CFHR1-High Subgroup Population)

Time frame: Baseline, Week 24

Change From Baseline in the PANSS Subscale Scores at Week 24 (All-Participant Population)

Time frame: Baseline, Week 24

Change From Baseline in the PANSS Subscale Scores at Week 24 (CFHR1-High Subgroup Population)

Time frame: Baseline, Week 24

Percentage of Participants Who Have at least 20 Percent (%) Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 (All-Participant Population)

Time frame: Baseline, Week 24

Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 (CFHR1-High Subgroup Population)

Time frame: Baseline, Week 24

Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score for Two out of Three Assessments During 24 Weeks (All-Participant Population)