A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone, paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms. After a 4 week run in period on their current anti psychotic 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 o n study treatment is \<3 months, and the target sample size is 100-500 individual s.

Key facts

Study ID

NCT00616798

Run by

Hoffmann-La Roche

People needed

323

Starts

2008-03-01

Expected to finish

2010-02-01

Last updated by the study team

2014-06-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Oceanside, California, United States
• Study site — Torrance, California, United States
• Study site — Atlanta, Georgia, United States
• Study site — Hoffman Estates, Illinois, United States
• Study site — Brooklyn, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Austin, Texas, United States
• Study site — Austin, Texas, United States
• Study site — DeSoto, Texas, United States
• Study site — Irving, Texas, United States
• Study site — Vienna, Austria
• Study site — Vienna, Austria
• Study site — Curitiba, Brazil
• Study site — Pelotas, Brazil
• Study site — Rio de Janeiro, Brazil
• Study site — Salvador, Brazil
• Study site — São Paulo, Brazil
• Study site — São Paulo, Brazil
• Study site — Marseille, France
• Study site — Orvault, France
• Study site — Toulon, France
• Study site — Granada Hills, California, United States

Full record on ClinicalTrials.gov

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