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A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)

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ClinicalTrials.gov Identifier: NCT01235559
Recruitment Status : Completed
First Posted : November 5, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

October 22, 2010
November 5, 2010
November 2, 2016
December 2010
March 2015   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01235559 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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: Week 52 ]
Not Provided
Not Provided
 
A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)
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.
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Placebo
    Oral doses, once a day for 52 weeks
  • Drug: bitopertin [RO4917838] level 1
    Oral dose level 1, once a day for 52 weeks
  • Drug: bitopertin [RO4917838] level 2
    Oral dose level 2, once a day for 52 weeks
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: bitopertin [RO4917838] 1
    Intervention: Drug: bitopertin [RO4917838] level 1
  • Experimental: bitopertin [RO4917838] 2
    Intervention: Drug: bitopertin [RO4917838] level 2
Bugarski-Kirola D, Iwata N, Sameljak S, Reid C, Blaettler T, Millar L, Marques TR, Garibaldi G, Kapur S. Efficacy and safety of adjunctive bitopertin versus placebo in patients with suboptimally controlled symptoms of schizophrenia treated with antipsychotics: results from three phase 3, randomised, double-blind, parallel-group, placebo-controlled, multicentre studies in the SearchLyte clinical trial programme. Lancet Psychiatry. 2016 Dec;3(12):1115-1128. doi: 10.1016/S2215-0366(16)30344-3. Epub 2016 Nov 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
604
600
March 2015
March 2015   (Final data collection date for primary outcome measure)

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"
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   China,   Czech Republic,   Italy,   Japan,   Russian Federation,   United States
India
 
NCT01235559
WN25305
2010-020718-26
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP