A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.
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ClinicalTrials.gov Identifier: NCT00616798 |
Recruitment Status
:
Completed
First Posted
: February 15, 2008
Last Update Posted
: June 24, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Drug: RO4917838 Drug: Placebo Drug: Standard antipsychotic therapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 323 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (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 |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | February 2010 |
Actual Study Completion Date : | February 2010 |

Arm | Intervention/treatment |
---|---|
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
|
- Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score. [ Time Frame: Week 8 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616798

Study Director: | Clinical Trials | Hoffmann-La Roche |
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 |
First Posted: | February 15, 2008 Key Record Dates |
Last Update Posted: | June 24, 2014 |
Last Verified: | June 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 |