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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01234779
First received: November 3, 2010
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

This randomized, double-blind, placebo- and active-controlled, parallel group st udy 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 Intervention Phase
Schizophrenia
Drug: bitopertin [RO4917838]
Drug: olanzapine
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II/III, 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: from baseline to Day 28 ] [ Designated as safety issue: No ]
  • Safety: Incidence adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response, defined as at least 30% or 50% improvement from baseline PANSS total score [ Time Frame: from baseline to Day 28 ] [ Designated as safety issue: No ]
  • Change in symptomatology as measured by the PANSS factor and subscale scores [ Time Frame: from baseline to Day 28 ] [ Designated as safety issue: No ]
  • Global improvement as measured by the Clinical Global Impressions-Severity (CGI-S) scale [ Time Frame: from baseline to Day 28 ] [ Designated as safety issue: No ]
  • Global improvement as measured by the Clinical Global Impressions-Change (CGI-C) rating scale [ Time Frame: from baseline to Day 28 ] [ Designated as safety issue: No ]
  • Observable behavioural change as determined by the Nurses' Observation Scale For Inpatient Evaluation (NOSIE) [ Time Frame: from baseline to Day 28 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 301
Study Start Date: February 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01234779

  Show 46 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01234779     History of Changes
Other Study ID Numbers: WN25333, 2010-021984-33
Study First Received: November 3, 2010
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on August 19, 2014