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

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: RO4917838; Drug: Placebo; Drug: Antipshychotics (Standard of Care)

• Registration Number: NCT01192867
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-30
• Study First Submitted QC: 2010-08-30
• Study First Posted: 2010-09-01
• Study Start: 2010-12-11
• Disposition First Submitted: 2013-08-20
• Disposition First Submitted QC: 2013-08-20
• Disposition First Posted: 2013-08-28
• Primary Completion: 2014-05-26
• Study Completion: 2014-05-26
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-23
• Last Update Posted: 2017-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 629

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RO4917838 20 milligrams (mg)	Antipshychotics (Standard of Care)	Participants, on stable antipsychotics, will receive RO4917838 orally at 20 mg once daily (QD) up to 56 weeks followed by an optional treatment extension for up to 3 years.
RO4917838 20 milligrams (mg)	RO4917838	Participants, on stable antipsychotics, will receive RO4917838 orally at 20 mg once daily (QD) up to 56 weeks followed by an optional treatment extension for up to 3 years.
RO4917838 10 mg	Antipshychotics (Standard of Care)	Participants, on stable antipsychotics, will receive RO4917838 orally at 10 mg QD up to 56 weeks followed by an optional treatment extension for up to 3 years.
Placebo	Placebo	Participants, on stable antipsychotics, will receive RO4917838 matching placebo orally QD up to 56 weeks.
RO4917838 10 mg	RO4917838	Participants, on stable antipsychotics, will receive RO4917838 orally at 10 mg QD up to 56 weeks followed by an optional treatment extension for up to 3 years.
Placebo	Antipshychotics (Standard of Care)	Participants, on stable antipsychotics, will receive RO4917838 matching placebo orally QD up to 56 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Positive and Negative Symptoms Scales (PANSS) Negative Symptoms Factor Score at Week 24 (All-Participant Population)	Baseline, Week 24
Percentage of Participants With Adverse Events (All-Participant Population)	Week 24

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the PANSS Negative Symptoms Factor Score at Week 24 (Complement Factor H Related Protein 1 High [CFHR1-High] Subgroup Population)	Baseline, Week 24
Change From Baseline in the Personal and Social Performance (PSP) Total Score at Week 24 (All-Participant Population)	Baseline, Week 24
Change From Baseline in the PSP Total Score at Week 24 (CFHR1-High Subgroup Population)	Baseline, Week 24
Change From Baseline in the PANSS Total Score at Week 24 (All-Participant Population)	Baseline, Week 24
Change From Baseline in the PANSS Total Score at Week 24 (CFHR1-High Subgroup Population)	Baseline, Week 24
Change From Baseline in the PANSS Factor Score at Week 24 (All-Participant Population)	Baseline, Week 24
Change From Baseline in the PANSS Factor Score at Week 24 (CFHR1-High Subgroup Population)	Baseline, Week 24
Change From Baseline in the PANSS Subscale Scores at Week 24 (All-Participant Population)	Baseline, Week 24
Change From Baseline in the PANSS Subscale Scores at Week 24 (CFHR1-High Subgroup Population)	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)	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)	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)	Baseline up to 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 (CFHR1-High Subgroup Population)	Baseline up to Week 24
Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on Clinical Global Impression - Improvement (CGI-I) Score (All-Participant Population)	Baseline, Week 24
Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score (CFHR1 Subgroup Population)	Baseline, Week 24
Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score for Two out of Three Assessments During 24 Weeks (All-Participant Population)	Baseline up to Week 24
Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score for Two out of Three Assessments During 24 Weeks (CFHR1 Subgroup Population)	Baseline up to Week 24
Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score (All-Participant Population)	Baseline, Week 24
Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score (CFHR1 Subgroup Population)	Baseline, Week 24
Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score for Two out of Three Assessments During 24 Weeks (All-Participant Population)	Baseline up to Week 24
Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score for Two out of Three Assessments During 24 Weeks (CFHR1 Subgroup Population)	Baseline up to Week 24
Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 and Improvement in the Negative Symptoms Based on CGI-I Negative Symptoms Score (All-Participant Population)	Baseline, Week 24
Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 and Improvement in the Negative Symptoms Based on CGI-I Negative Symptoms Score (CFHR1 Subgroup Population)	Baseline, Week 24
Change From Baseline in Severity of Illness Based on Clinical Global Impression - Severity (CGI-S) Overall Score (All-Participant Population)	Baseline, Week 24
Change From Baseline in Severity of Illness Based on CGI-S Overall Score (CFHR1 Subgroup Population)	Baseline, Week 24
Change From Baseline in Severity of Illness Based on CGI-S Negative Symptoms Score (All-Participant Population)	Baseline, Week 24
Change From Baseline in Severity of Illness Based on CGI-S Negative Symptoms Score (CFHR1 Subgroup Population)	Baseline, Week 24

Trial Locations

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

Pasadena Research Institute; 🇺🇸 Pasadena, California, United States

CNRI - Los Angeles, LLC; 🇺🇸 Pico Rivera, California, United States

Pharmax Research Clinic Inc.; 🇺🇸 Miami, Florida, United States

Northwest Behavioral Research Center; 🇺🇸 Marietta, Georgia, United States

American Medical Research, Inc; 🇺🇸 Oak Brook, Illinois, United States

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