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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01116830
First received: May 4, 2010
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This randomized, double-blind, placebo-controlled parallel group study will asse ss the effect on biomarkers measures of cognitive dysfunction, the clinical effi cacy and safety of RO4917383 in patients with schizophrenia and schizoaffective disorder. Patients will be randomized to receive either RO4917383 (10mg daily or ally) or placebo for 6 weeks, in addition to their stable antipsychotic medicati on. Anticipated time on study treatment is 6 weeks.


Condition Intervention Phase
Schizophrenia, Schizoaffective Disorder
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 (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Parallel Arm Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Schizophrenia and Schizoaffective Disorder

Resource links provided by NLM:


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, GAF, MATRICS battery) [ Time Frame: weeks 1, 3 and 6 ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: November 2010
Study Completion Date: February 2014
Primary Completion Date: February 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 or schizoaffective disorder (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

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
  • bipolar disorder, or more than mild anxiety disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Disease
Psychotic Disorders
Cognition Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Pathologic Processes
Delirium, Dementia, Amnestic, Cognitive 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 September 18, 2014