A Study of RO4917838 (Bitopertin) in Patients With Acute Exacerbation of Schizophrenia

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. Identifier: NCT01234779
Recruitment Status : Completed
First Posted : November 4, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This randomized, double-blind, placebo- and active-controlled, parallel group study will evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute exacerbation of schizophrenia. Patients will be randomized to receive either RO4917838 10 mg or RO4917838 30 mg or olanzapine 15 mg or placebo orally daily for 4 weeks as inpatients, with a 4-week follow-up period.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: bitopertin [RO4917838] Drug: olanzapine Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Multi-center, Randomized, 4-week, Double-blind, Parallel Group, Placebo and Active-controlled Trial of the Safety and Efficacy of RO4917838 vs. Placebo in Patients With an Acute Exacerbation of Schizophrenia
Study Start Date : February 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: bitopertin [RO4917838]
10 mg orally daily, 4 weeks
Experimental: B Drug: bitopertin [RO4917838]
30 mg orally daily, 4 weeks
Active Comparator: C Drug: olanzapine
15 mg orally daily, 4 weeks
Placebo Comparator: D Drug: placebo
orally daily, 4 weeks

Primary Outcome Measures :
  1. Change in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: from baseline to Day 28 ]
  2. Safety: Incidence adverse events [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Clinical response, defined as at least 30% or 50% improvement from baseline PANSS total score [ Time Frame: from baseline to Day 28 ]
  2. Change in symptomatology as measured by the PANSS factor and subscale scores [ Time Frame: from baseline to Day 28 ]
  3. Global improvement as measured by the Clinical Global Impressions-Severity (CGI-S) scale [ Time Frame: from baseline to Day 28 ]
  4. Global improvement as measured by the Clinical Global Impressions-Change (CGI-C) rating scale [ Time Frame: from baseline to Day 28 ]
  5. Observable behavioural change as determined by the Nurses' Observation Scale For Inpatient Evaluation (NOSIE) [ Time Frame: from baseline to Day 28 ]
  6. Time to readiness for discharge from inpatient unit as assessed by the Readiness For Hospital Discharge Questionnaire (RDQ) [ Time Frame: from baseline to Day 28 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, 18-65 years of age
  • Diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders DSM IV-TR)
  • Acute exacerbation which began within the prior 8 weeks
  • Female patients must be surgically sterile or post-menopausal, or agree to use effective contraception for the duration of the study

Exclusion Criteria:

  • Current psychiatric diagnosis other than schizophrenia
  • Alcohol or substance dependence within 3 months or abuse within 1 month (except for nicotine)
  • Electro-convulsive therapy (ECT) within the prior 6 months
  • Previous treatment with RO4917838 or another GLYT inhibitor
  • Current treatment with olanzapine, or previous treatment with intolerability or lack of response
  • Treatment with long-acting injectable antipsychotic within 2 dosing intervals
  • Treatment with > 2 antipsychotics within 3 months
  • History of neuroleptic malignant syndrome
  • Have treatment-resistant schizophrenia as judged by treating physician or have failed two trials according to criteria in protocol

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 identifier (NCT number): NCT01234779

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Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01234779     History of Changes
Other Study ID Numbers: WN25333
First Posted: November 4, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents