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Therapeutic Areas: Psychiatry/Psychology
Disease Category: Schizophrenia and Schizoaffective Disorders
Trial Information
A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.
Status: Recruiting
Protocol Number: NN20372
Sponsor: Hoffmann-La Roche
Company Division: Pharmaceutical
Official Scientific Title: Randomized, double-blind, placebo-controlled add-on trial of the safety and efficacy of RO4917838 in outpatients on select atypical antipsychotics with prominent negative or disorganized thought symptoms
Brief Summary: This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, quetiapine, risperidone, paliperidone or aripiprazole) with prominent negative or disorganized thought symptoms. After a 4 week run in period on their current antipsychotic treatment, patients will be randomized to receive placebo 10mg, 30mg, or 60mg of RO4917838 once daily, p.o., as add-on therapy. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals. Target sample size is 320.
Study Phase: II
Study Design / Study Details:
- Purpose: Treatment
- Allocation: Randomized
- Masking: Double Blind
- Control: Placebo
- Assignment: Parallel
- Endpoints: Safety/Efficacy
Study Type:
Interventional
Condition: Schizophrenia
Intervention Type: Drug
Intervention Name: RO4917838
Primary Outcome: 1. Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score. Time frame: Week 8
Key Secondary Outcomes: 1. Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes. Time frame: Throughout study
2. AEs, laboratory parameters. Time frame: Throughout study
Inclusion Criteria:
- adult patients, 18-60 years of age;
- diagnosis of schizophrenia (based on screening tests);
- outpatients, with no hospitalization for worsening of schizophrenia within 3 months;
- medically and psychiatrically stable over prior 1 month and psychiatrically stable without symptom exacerbation within prior 3 months;
- currently taking no more than 2 antipsychotic drugs.
Exclusion Criteria:
- began a new non-medication treatment for schizophrenia or other psychiatric condition within last 3 months;
- on >1 antidepressant, or a change in dose of antidepressant within 3 months;
- alcohol or substance abuse or dependence within 3 months;
- has previously received RO4917838.
Gender: Males or Females
Age Limits: Min: 18 Years Max: 60 Years
Accepts Healthy Volunteers: No
Anticipated Start Date: April, 2008
Trial Registration Date: 02/04/2008
Date Last Updated: 12/08/2008
Link To Trial Results
Research Site:
Located In:
Sao Paulo 05651-901
Brazil
Phone: 973-235-5000 or 800-526-6367
View Google Map
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