A Study of RO4917838 (Bitopertin) in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia (WN25309)
This study is currently recruiting participants.
Verified February 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01192906
First received: August 30, 2010
Last updated: February 4, 2013
Last verified: February 2013
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Purpose
This multi-center, randomized, double blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with persistent, predominant negative symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: bitopertin [RO4917838] Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase III, Multi-center, Randomized, 24 Week, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate Efficacy and Safety of RO4917838 in Stable Patients With Persistent, Predominant Negative Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 28 Week, Double-blind Treatment Period. |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Efficacy (PANSS negative symptoms factor score) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- Safety (incidence of adverse events) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 630 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: bitopertin [RO4917838]
Oral dose level 1, once a day for 52 weeks
|
| Experimental: 2 |
Drug: bitopertin [RO4917838]
Oral dose level 2, once a day for 52 weeks
|
| Placebo Comparator: 3 |
Drug: Placebo
Oral doses, once a day for 52 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, aged 18 years and above
- Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype
- Predominant negative symptoms
- With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics)
Exclusion Criteria:
- Evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
- Body Mass Index (BMI) <18.5 or >40
- Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS)
- A severity score of 3 or greater on the Parkinsonism item of the ESRS-A (Clinical Global Impression, Parkinsonism)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192906
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Contacts
| Contact: Please reference Study ID Number: WN25309 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Hide Study LocationsLocations
| United States, California | |
| Recruiting | |
| Carson, California, United States, 90746 | |
| Not yet recruiting | |
| Long Beach, California, United States, 90822 | |
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| Oceanside, California, United States, 92056 | |
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| Oceanside, California, United States, 92056 | |
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| San Diego, California, United States, 92123 | |
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| San Diego, California, United States, 92121 | |
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| San Diego, California, United States, 92123 | |
| United States, Connecticut | |
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| Hartford, Connecticut, United States, 06106 | |
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| Norwalk, Connecticut, United States, 06851 | |
| United States, Florida | |
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| North Miami, Florida, United States, 33161 | |
| United States, Georgia | |
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| Atlanta, Georgia, United States, 30328 | |
| United States, Illinois | |
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| Chicago, Illinois, United States, 60612 | |
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| Hoffman Estates, Illinois, United States, 60169 | |
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| Joliet, Illinois, United States, 60435 | |
| United States, Louisiana | |
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| Lake Charles, Louisiana, United States, 70601 | |
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| Shreveport, Louisiana, United States, 71104-2136 | |
| United States, Minnesota | |
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| Minneapolis, Minnesota, United States, 55454 | |
| United States, Missouri | |
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| St Louis, Missouri, United States, 63118 | |
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| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
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| Omaha, Nebraska, United States, 68131 | |
| United States, New York | |
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| Cedarhurst, New York, United States, 11516 | |
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| Jamaica, New York, United States, 11418 | |
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| Rochester, New York, United States, 14623 | |
| United States, Pennsylvania | |
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| Allentown, Pennsylvania, United States, 18104 | |
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| Norristown, Pennsylvania, United States, 19403 | |
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| Philadelphia, Pennsylvania, United States, 19139 | |
| United States, Washington | |
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| Bothell, Washington, United States, 98011 | |
| Brazil | |
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| Belo Horizonte, Brazil, 30150-270 | |
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| Criciuma, Brazil, 88806-000 | |
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| Curitiba, Brazil, 80240-280 | |
| Active, not recruiting | |
| Goiania, Brazil, 74922-810 | |
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| Itapira, Brazil, 13970-905 | |
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| Pelotas, Brazil, 96030-002 | |
| Completed | |
| Porto Alegre, Brazil, 90035-003 | |
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| Rio de Janeiro, Brazil, 2270-060 | |
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| Salvador, Brazil, 40301-500 | |
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| Sao Paulo, Brazil, 05403-010 | |
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| Sao Paulo, Brazil, 04044-000 | |
| Canada, Alberta | |
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| Calgary, Alberta, Canada, T2N 4Z6 | |
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| Medicine Hat, Alberta, Canada, T1B 4E7 | |
| Canada, British Columbia | |
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| Vancouver, British Columbia, Canada, V5Z 3P1 | |
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| Victoria, British Columbia, Canada, V8R 1J8 | |
| Canada, Nova Scotia | |
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| Halifax, Nova Scotia, Canada, B3H 2E2 | |
| Canada, Ontario | |
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| Burlington, Ontario, Canada, L7R 4E2 | |
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| Hamilton, Ontario, Canada, L8N 3K7 | |
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| Mississauga, Ontario, Canada, L5M 4N4 | |
| Canada, Quebec | |
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| Montreal, Quebec, Canada, H3A 1A1 | |
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| Montreal, Quebec, Canada, H4H IR3 | |
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| Montreal, Quebec, Canada, H1N 3M5 | |
| Chile | |
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| Santiago, Chile | |
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| Santiago, Chile, 8320000 | |
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| Santiago, Chile, 8900000 | |
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| Santiago, Chile, 8050000 | |
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| Valdivia, Chile, 5090000 | |
| Germany | |
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| Berlin, Germany, 10117 | |
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| Bochum, Germany, 44805 | |
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| Freiburg, Germany, 79104 | |
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| Hamburg, Germany, 20246 | |
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| Koeln, Germany, 50924 | |
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| Muenchen, Germany, 80336 | |
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| Muenchen, Germany, 81675 | |
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| Nurenberg, Germany, 90402 | |
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| Siegen, Germany, 57072 | |
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| Werneck, Germany, 97440 | |
| Latvia | |
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| Daugavpils, Latvia, 5417 | |
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| Daugavpils, Latvia, 5417 | |
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| Jelgava, Latvia, LV-3008 | |
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| Liepaja, Latvia, 3401 | |
| Lithuania | |
| Recruiting | |
| Kaunas, Lithuania, 53136 | |
| Terminated | |
| Kaunas, Lithuania, 50009 | |
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| Kaunas, Lithuania, 48259 | |
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| Kaunas, Lithuania, 50185 | |
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| Silute, Lithuania, 99142 | |
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| Vilnius, Lithuania, 07156 | |
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| Vilnius, Lithuania, 10204 | |
| Netherlands | |
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| Assen, Netherlands, 9400 RA | |
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| Groningen, Netherlands, 9713 GZ | |
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| Groningen, Netherlands, 9725 AG | |
| Poland | |
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| Choroszcz, Poland, 16-070 | |
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| Kielce, Poland, 25-317 | |
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| Lublin, Poland, 20-582 | |
| Not yet recruiting | |
| Lublin, Poland, 20-045 | |
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| Lublin, Poland, 20-109 | |
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| Piekary Slaskie, Poland, 41-940 | |
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| Skorzewo, Poland, 60-165 | |
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| Tuszyn, Poland, 95-080 | |
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| Warszawa, Poland, 02-957 | |
| Slovakia | |
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| Bojnice, Slovakia, 972 01 | |
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| Bratislava, Slovakia, 851 01 | |
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| Bratislava, Slovakia, 820 07 | |
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| Michalovce, Slovakia, 071 01 | |
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| Rimavska Sobota, Slovakia, 979 01 | |
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| Rimavska Sobota, Slovakia, 979 12 | |
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| Svidnik, Slovakia, 089 01 | |
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| Trnava, Slovakia, 917 75 | |
| Spain | |
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| Barcelona, Spain, 08036 | |
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| Barcelona, Spain, 08830 | |
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| Barcelona, Spain, 08304 | |
| Terminated | |
| Madrid, Spain, 28040 | |
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| Madrid, Spain, 28009 | |
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| Oviedo, Spain, 33011 | |
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| Salamanca, Spain, 37007 | |
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| Zamora, Spain, 49021 | |
| Taiwan | |
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| Hualien, Taiwan, 981 | |
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| Kaohsiung, Taiwan, 802 | |
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| Tainan, Taiwan, 704 | |
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| Tainan County, Taiwan, 717 | |
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| Taipei, Taiwan, 112 | |
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| Taipei, Taiwan, 110 | |
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| Taiwan, Taiwan, 407 | |
| Turkey | |
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| Ankara, Turkey, 06100 | |
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| Ankara, Turkey, 06100 | |
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| Diyarbakir, Turkey, 10000 | |
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| Gaziantep, Turkey, 27310 | |
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| Istanbul, Turkey, 34736 | |
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| Istanbul, Turkey, 34390 | |
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| Istanbul, Turkey, 34098 | |
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| Izmir, Turkey, 35340 | |
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| Kocaeli, Turkey, 41380 | |
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| Manisa, Turkey, 45010 | |
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| Mersin, Turkey, 33169 | |
| Ukraine | |
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| Dnipropetrovsk, Ukraine, 49005 | |
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| Donetsk, Ukraine, 83008 | |
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| Glevakha Kyviv Region, Ukraine, 08631 | |
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| Kharkiv, Ukraine, 61068 | |
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| Kiev, Ukraine, 01030 | |
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| Kyiv, Ukraine, 04080 | |
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| Kyiv, Ukraine, 02660 | |
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| Lviv, Ukraine, 79021 | |
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| Odessa, Ukraine, 65006 | |
| Recruiting | |
| Vinnytsya, Ukraine, 21005 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01192906 History of Changes |
| Other Study ID Numbers: | WN25309, 2010-020467-21 |
| Study First Received: | August 30, 2010 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013