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NCT Number: NCT01234779

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arad, Romania

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bitopertin [RO4917838]

Drug

10 mg orally daily, 4 weeks

Olanzapine

Drug

15 mg orally daily, 4 weeks

Placebo

Drug

orally daily, 4 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 4, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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