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

NCT00616798 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2014-06-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

RO4917838

10mg po daily

DRUG

RO4917838

30mg po daily

DRUG

RO4917838

60mg po daily

DRUG

Placebo

po daily

DRUG

Standard antipsychotic therapy

As prescribed

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States
  • Austria
  • Brazil
  • France
  • Germany
  • Hungary
  • Japan
  • Mexico
  • Poland
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00616798 on ClinicalTrials.gov