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A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00616798
First received: February 4, 2008
Last updated: June 23, 2014
Last verified: June 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Schizophrenia | Drug: RO4917838 Drug: Placebo Drug: Standard antipsychotic therapy | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
schizophrenia
MedlinePlus related topics:
Schizophrenia
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score. [ Time Frame: Week 8 ]
Secondary Outcome Measures:
- Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes. [ Time Frame: Throughout study ]
- AEs, laboratory parameters, C-SSRS [ Time Frame: Throughout study ]
| Enrollment: | 323 |
| Study Start Date: | March 2008 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 3 |
Drug: RO4917838
60mg po daily
Drug: Standard antipsychotic therapy
As prescribed
|
| Placebo Comparator: 4 |
Drug: Placebo
po daily
Drug: Standard antipsychotic therapy
As prescribed
|
| Experimental: 1 |
Drug: RO4917838
10mg po daily
Drug: Standard antipsychotic therapy
As prescribed
|
| Experimental: 2 |
Drug: RO4917838
30mg po daily
Drug: Standard antipsychotic therapy
As prescribed
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00616798
Show 73 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616798
Show 73 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00616798 History of Changes |
| Other Study ID Numbers: |
NN20372 |
| Study First Received: | February 4, 2008 |
| Last Updated: | June 23, 2014 |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 23, 2017