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A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25306)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01235585
First received: October 22, 2010
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.

Condition Intervention Phase
Schizophrenia Drug: Placebo Drug: bitopertin [RO4917838] Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase III, Multi-center, Randomized, 12-week, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 40-week Double-blind, Parallel-group, Placebo-controlled Treatment Period.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Change from baseline to Week 12 ]
  • Safety (incidence of adverse events) [ Time Frame: Week 12 ]

Secondary Outcome Measures:
  • Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Change from baseline to Week 12 ]
  • Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale [ Time Frame: Change from baseline to Week 12 ]
  • Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale [ Time Frame: Change from baseline to Week 12 ]
  • Safety (incidence of adverse events) [ Time Frame: 60 weeks ]

Enrollment: 597
Study Start Date: December 2010
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bitopertin oral dose level 1 Drug: bitopertin [RO4917838]
Oral dose level 1, once a day for 52 weeks
Experimental: Bitopertin oral dose level 2 Drug: bitopertin [RO4917838]
Oral dose level 2, once a day for 52 weeks
Placebo Comparator: Placebo Drug: Placebo
Oral doses, once a day for 52 weeks

  Eligibility

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

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Diagnosis of schizophrenia
  • Clinical stability for 16 weeks (4 months) prior to randomization
  • Antipsychotic treatment stability for the past 12 weeks prior to randomization
  • With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics)

Exclusion Criteria:

  • Has treatment resistant schizophrenia as judged by the treating physician OR have failed two trials
  • Evidence that patient has clinically significant uncontrolled or unstable medical disorder (e.g. cardiovascular, renal hepatic, gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease)
  • Patient has a body mass index (BMI) of <17 or >40 kg/m2, respectively)
  • Diagnosis of mental retardation or severe organic brain syndromes
  • In the investigator's judgment, a significant risk of suicide or violent behavior
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235585

  Show 120 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01235585     History of Changes
Other Study ID Numbers: WN25306
2010-020616-11
Study First Received: October 22, 2010
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 23, 2017