Clinical Trial Protocol Registry

Trial information

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

Status:
Completed
Protocol number:
WN25333
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Official Scientific 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
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. Target sample size is 301.
Study phase:
II
Study type:
Interventional; Treatment; Randomized; Double Blind; Parallel; Safety/efficacy study
Conditions:
  • Schizophrenia
Primary outcome:
  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
Key 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
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
Gender:
Males or Females
Age limits:
Min: 18 years Max: 65 years
Accepts healthy volunteers:
No
Anticipated start date:
February, 2011
Trial registration date:
22.10.2010
Date last updated:
10.06.2013
This trial was conducted at the following locations:
ROMANIA
  • Arad
  • Bucuresti
  • Foscani
  • Oradea
  • Targoviste
Russian Federation
  • MOSCOW
RUSSIAN FEDERATION
  • Gatchina
  • Petrozavodsk
  • St. Petersburg
  • St Petersburg
  • Talagi
SLOVAKIA
  • Bojnice
  • BRATISLAVA
  • Liptovsky Mikulas
  • Michalovce
U.S.A.
  • OCEANSIDE, CA
  • ATLANTA, GA
  • PHILADELPHIA, PA
  • AUSTIN, TX
  • IRVING, TX
UKRAINE
  • Dnipropetrovsk
  • Donetsk
  • Kherson,Vil. Stepanivka
  • Kyiv
  • Poltava
  • Vinnytsya
UNITED STATES
  • Little Rock, AR
  • Cerritos, CA
  • Pico Rivera, CA
  • San Diego, CA
  • Lauderhill, FL
  • North Miami, FL
  • Lake Charles, LA
  • St Louis, MO
  • Flowood, MS
  • Willingboro, NJ
  • Holliswood, NY
  • New York, NY
  • Cincinnati, OH
  • Charlesston, SC

Link to trial result

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