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

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: RO4917838; Drug: Placebo; Drug: Standard antipsychotic therapy

• Registration Number: NCT00616798
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-15
• Study Start: 2008-03
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Disposition First Submitted: 2013-08-20
• Disposition First Submitted QC: 2013-08-20
• Disposition First Posted: 2013-08-28
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 323

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	RO4917838	-
3	Standard antipsychotic therapy	-
4	Placebo	-
4	Standard antipsychotic therapy	-
1	RO4917838	-
1	Standard antipsychotic therapy	-
2	RO4917838	-
2	Standard antipsychotic therapy	-

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score.	Week 8

Secondary Outcome Measures

Name	Time	Method
Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes.	Throughout study
AEs, laboratory parameters, C-SSRS	Throughout study