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. 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

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

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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.

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 identifier (NCT number): NCT00616798

  Hide Study Locations
United States, California
Granada Hills, California, United States, 91344
Los Angeles, California, United States, 90033
Oceanside, California, United States, 92056
Torrance, California, United States, 90502
United States, Georgia
Atlanta, Georgia, United States, 30308
United States, Illinois
Hoffman Estates, Illinois, United States, 60169
United States, New York
Brooklyn, New York, United States, 11203
United States, Ohio
Cincinnati, Ohio, United States, 45267
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
Austin, Texas, United States, 78754
Austin, Texas, United States, 78756
De Soto, Texas, United States, 75115
Irving, Texas, United States, 75062
Wien, Austria, 1010
Wien, Austria, 1090
Curitiba, Brazil, 80520-000
Pelotas, Brazil, 96030-002
Rio de Janeiro, Brazil, 21020-130
Salvador, Brazil, 40301-500
Sao Paulo, Brazil, 04044-000
Sao Paulo, Brazil, 05403-010
Marseille, France, 13009
Orvault, France, 44700
Toulon, France, 83056
Achim, Germany, 28832
Bochum, Germany, 44805
Freiburg, Germany, 79104
Hamburg, Germany, 20246
Nürnberg, Germany, 90402
Westerstede, Germany, 26655
Balassagyarmat, Hungary, 2660
Budapest, Hungary, 1083
Budapest, Hungary, 1097
Budapest, Hungary, 1125
Budapest, Hungary, 1135
GYR, Hungary, 9024
Gyula, Hungary, 5700
Nyíregyháza, Hungary, 4400
Aichi, Japan, 470-1192
Chiba, Japan, 272-8516
Fukuoka, Japan, 807-8555
Fukuoka, Japan, 812-8582
Gunma, Japan, 373-0054
Kanagawa, Japan, 232-0024
Kanagawa, Japan, 236-0004
Nagasaki, Japan, 852-8501
Saga, Japan, 842-0192
Sapporo, Japan, 060-8638
Tokushima, Japan, 770-8503
Tokyo, Japan, 162-8666
Tokyo, Japan, 187-8551
Mexico City, Mexico, 06100
Mexico City, Mexico, 11560
Mexico City, Mexico, 1400
Mexico City, Mexico, 14370
Monterrey, Mexico, 64710
Bydgoszcz, Poland, 85-096
Kielce, Poland, 25-317
Skorzewo, Poland, 60-165
Torun, Poland, 87-100
Tuszyn, Poland, 95-080
Zuromin, Poland, 09-300
Russian Federation
Kazan, Russian Federation, 420012
Lipetsk, Russian Federation, 399313
Moscow, Russian Federation, 115522
Moscow, Russian Federation, 117152
Moscow, Russian Federation, 123367
Nizhny Novgorod, Russian Federation, 603155
St Petersbourg, Russian Federation, 190005
St Petersburg, Russian Federation, 192019
St Petersburg, Russian Federation, 193019
St. Petersburg, Russian Federation, 193167
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche 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 Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs