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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01116830
First received: May 4, 2010
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Schizophrenia
 Drug: RO4917838
Drug: placebo
Drug: standard antipsychotic therapy
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in biomarker measures of cognitive dysfunction [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 23
Study Start Date: November 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: RO4917838
10mg daily orally for 6 weeks
Drug: standard antipsychotic therapy
as prescribed
Placebo Comparator: B Drug: placebo
orally daily for 6 weeks
Drug: standard antipsychotic therapy
as prescribed

  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 (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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116830

Locations
United States, New York
Orangeburg, New York, United States, 10962
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: NCT01116830     History of Changes
Other Study ID Numbers: BP22445
Study First Received: May 4, 2010
Last Updated: May 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 23, 2013