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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01192867
First Posted: September 1, 2010
Last Update Posted: June 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Schizophrenia Drug: Placebo Drug: RO4917838 Drug: Antipshychotics (Standard of Care) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multi-Center, Randomized, 24 Week, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate Efficacy and Safety of RO4917838 in Stable Patients With Persistent, Predominant Negative Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 28 Week, Double-Blind Treatment Period

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Baseline, Week 24 ]
  • Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score (CFHR1 Subgroup Population) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Baseline, Week 24 ]
  • Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score (CFHR1 Subgroup Population) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ 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 and Improvement in the Negative Symptoms Based on CGI-I Negative Symptoms Score (CFHR1 Subgroup Population) [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline in Severity of Illness Based on Clinical Global Impression - Severity (CGI-S) Overall Score (All-Participant Population) [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline in Severity of Illness Based on CGI-S Overall Score (CFHR1 Subgroup Population) [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline in Severity of Illness Based on CGI-S Negative Symptoms Score (All-Participant Population) [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline in Severity of Illness Based on CGI-S Negative Symptoms Score (CFHR1 Subgroup Population) [ Time Frame: Baseline, Week 24 ]

Enrollment: 629
Actual Study Start Date: December 11, 2010
Study Completion Date: May 26, 2014
Primary Completion Date: May 26, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RO4917838 20 milligrams (mg)
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.
Drug: RO4917838
RO4917838 will be administered orally at 20 or 10 mg QD for 56 weeks.
Drug: Antipshychotics (Standard of Care)
Participants will continue to receive their stable antipshychotic as standard of care based on their prescription up to Week 56.
Experimental: RO4917838 10 mg
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.
Drug: RO4917838
RO4917838 will be administered orally at 20 or 10 mg QD for 56 weeks.
Drug: Antipshychotics (Standard of Care)
Participants will continue to receive their stable antipshychotic as standard of care based on their prescription up to Week 56.
Placebo Comparator: Placebo
Participants, on stable antipsychotics, will receive RO4917838 matching placebo orally QD up to 56 weeks.
Drug: Placebo
Placebo will be administered orally QD for 56 weeks
Drug: Antipshychotics (Standard of Care)
Participants will continue to receive their stable antipshychotic as standard of care based on their prescription up to Week 56.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192867


  Show 122 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01192867     History of Changes
Other Study ID Numbers: NN25310
2010-020370-42 ( EudraCT Number )
First Submitted: August 30, 2010
First Posted: September 1, 2010
Last Update Posted: June 26, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs