We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00616798
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : June 24, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: RO4917838 Drug: Placebo Drug: Standard antipsychotic therapy Phase 2

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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

Primary Outcome Measures :
  1. Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score. [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes. [ Time Frame: Throughout study ]
  2. AEs, laboratory parameters, C-SSRS [ Time Frame: Throughout study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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.

Information from the National Library of Medicine

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

Show Show 73 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00616798    
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:
Layout table for MeSH terms
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs