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A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Patients With Schizophrenia

This study is currently recruiting participants.
Verified June 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01116830
First received: May 4, 2010
Last updated: June 11, 2013
Last verified: June 2013
History of Changes

May 4, 2010
June 11, 2013
November 2010
October 2014   (final data collection date for primary outcome measure)
Change in biomarker measures of cognitive dysfunction [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01116830 on ClinicalTrials.gov Archive Site
  • Change in biomarker measures of cognitive dysfunction [ Time Frame: after 1 week of treatment ] [ Designated as safety issue: No ]
  • Predictive value of biomarker changes after 1 week for biomarker responses after 6 weeks [ Time Frame: 1 and 6 weeks ] [ Designated as safety issue: No ]
  • Predictive value of biomarker changes on changes in symptoms [ Time Frame: 1 and 6 weeks ] [ Designated as safety issue: No ]
  • Clinical efficacy (PANSS, NSA, CDS, CGI scales, MATRICS battery) [ Time Frame: weeks 1, 3 and 6 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Patients With Schizophrenia
Not Provided

This single centre, randomized, double-blind, placebo-controlled parallel group study will assess the effect on biomarkers measures of cognitive dysfunction, the clinical efficacy and safety of RO4917383 in patients with schizophrenia. Patients will be randomized to receive either RO4917383 (10mg daily orally) or placebo for 6 weeks, in addition to their stable antipsychotic medication. Anticipated time on study treatment is 6 weeks. Target sample size is <50 patients.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Schizophrenia
  • Drug: RO4917838
    10mg daily orally for 6 weeks
  • Drug: placebo
    orally daily for 6 weeks
  • Drug: standard antipsychotic therapy
    as prescribed
  • Experimental: A
    Interventions:
    • Drug: RO4917838
    • Drug: standard antipsychotic therapy
  • Placebo Comparator: B
    Interventions:
    • Drug: placebo
    • Drug: standard antipsychotic therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 18-65 years of age
  • diagnosis of schizophrenia (based on screening tests)
  • medically stable for 1 month and psychiatrically stable without symptom acerbation for 6 weeks prior to baseline
  • on stable treatment with a maximum of 2 antipsychotics (at least one of them olanzapine, quetiapine, paliperidone or risperidone)

Exclusion Criteria:

  • change in regimen for any psychotropic or sleep medication within 1 month
  • treatment with >1 mood stabilizer or antidepressant
  • use of clozapine within 2 months, or a depot long-acting antipsychotic other than risperidone within 3 months
  • bipolar or schizoaffective disorder, or more than mild depression or anxiety disorder
Both
18 Years to 65 Years
No
Contact: Reference Study ID Number: BP22445 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States
 
NCT01116830
BP22445
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
June 2013

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