Trial Information

Summary: 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: A randomized, double-blind placebo controlled add-on study of the effect of RO4917838 on schizophrenia symptoms in outpatients on olanzapine, quetiapine, risperidone or palperidone 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 or paliperidone) 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 280.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Placebo
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

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:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 55 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 02/04/2008

Date Last Updated: 04/16/2008

Link To Trial Results

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Trial listings updated: May 13, 2008 at 2:48:51 PM