A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.
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
1 other identifier
interventional
323
10 countries
73
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 schizophrenia
Started Mar 2008
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2008
CompletedFirst Posted
Study publicly available on registry
February 15, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedJune 24, 2014
June 1, 2014
1.9 years
February 4, 2008
June 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score.
Week 8
Secondary Outcomes (2)
Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes.
Throughout study
AEs, laboratory parameters, C-SSRS
Throughout study
Study Arms (4)
3
EXPERIMENTAL4
PLACEBO COMPARATOR1
EXPERIMENTAL2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (73)
Unknown Facility
Granada Hills, California, 91344, United States
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Los Angeles, California, 90033, United States
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Oceanside, California, 92056, United States
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Torrance, California, 90502, United States
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Atlanta, Georgia, 30308, United States
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Hoffman Estates, Illinois, 60169, United States
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Brooklyn, New York, 11203, United States
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Cincinnati, Ohio, 45267, United States
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Oklahoma City, Oklahoma, 73103, United States
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Philadelphia, Pennsylvania, 19139, United States
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Austin, Texas, 78754, United States
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Austin, Texas, 78756, United States
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DeSoto, Texas, 75115, United States
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Irving, Texas, 75062, United States
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Vienna, 1010, Austria
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Vienna, 1090, Austria
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Curitiba, 80520-000, Brazil
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Pelotas, 96030-002, Brazil
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Rio de Janeiro, 21020-130, Brazil
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Salvador, 40301-500, Brazil
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São Paulo, 04044-000, Brazil
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São Paulo, 05403-010, Brazil
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Marseille, 13009, France
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Orvault, 44700, France
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Toulon, 83056, France
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Achim, 28832, Germany
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Bochum, 44805, Germany
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Freiburg im Breisgau, 79104, Germany
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Hamburg, 20246, Germany
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Nuremberg, 90402, Germany
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Westerstede, 26655, Germany
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Balassagyarmat, 2660, Hungary
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Budapest, 1083, Hungary
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Budapest, 1097, Hungary
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Budapest, 1125, Hungary
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Budapest, 1135, Hungary
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GYR, 9024, Hungary
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Gyula, 5700, Hungary
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Nyíregyháza, 4400, Hungary
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Aichi, 470-1192, Japan
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Chiba, 272-8516, Japan
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Fukuoka, 807-8555, Japan
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Fukuoka, 812-8582, Japan
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Gunma, 373-0054, Japan
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Kanagawa, 232-0024, Japan
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Kanagawa, 236-0004, Japan
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Nagasaki, 852-8501, Japan
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Saga, 842-0192, Japan
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Sapporo, 060-8638, Japan
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Tokushima, 770-8503, Japan
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Tokyo, 162-8666, Japan
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Tokyo, 187-8551, Japan
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Mexico City, 06100, Mexico
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Mexico City, 11560, Mexico
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Mexico City, 1400, Mexico
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Mexico City, 14370, Mexico
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Monterrey, 64710, Mexico
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Bydgoszcz, 85-096, Poland
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Kielce, 25-317, Poland
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Skorzewo, 60-165, Poland
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Torun, 87-100, Poland
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Tuszyn, 95-080, Poland
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Żuromin, 09-300, Poland
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Kazan', 420012, Russia
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Lipetsk, 399313, Russia
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Moscow, 115522, Russia
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Moscow, 117152, Russia
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Moscow, 123367, Russia
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Nizhny Novgorod, 603155, Russia
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Saint Petersburg, 190005, Russia
Unknown Facility
Saint Petersburg, 192019, Russia
Unknown Facility
Saint Petersburg, 193019, Russia
Unknown Facility
Saint Petersburg, 193167, Russia
Related Publications (1)
Umbricht D, Alberati D, Martin-Facklam M, Borroni E, Youssef EA, Ostland M, Wallace TL, Knoflach F, Dorflinger E, Wettstein JG, Bausch A, Garibaldi G, Santarelli L. Effect of bitopertin, a glycine reuptake inhibitor, on negative symptoms of schizophrenia: a randomized, double-blind, proof-of-concept study. JAMA Psychiatry. 2014 Jun;71(6):637-46. doi: 10.1001/jamapsychiatry.2014.163.
PMID: 24696094DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2008
First Posted
February 15, 2008
Study Start
March 1, 2008
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
June 24, 2014
Record last verified: 2014-06