Back to resultsA Study of RO4917838 (Bitopertin) in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia (WN25309)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
bitopertin [RO4917838]
bitopertin [RO4917838]
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility 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) of <17 or >40 kg/m2
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Efficacy (PANSS negative symptoms factor score)
Safety (incidence of adverse events)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01192906
Brief Title
A Study of RO4917838 (Bitopertin) in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia (WN25309)
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
624 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral doses, once a day for 52 weeks
Intervention Type
Drug
Intervention Name(s)
bitopertin [RO4917838]
Intervention Description
Oral dose level 1, once a day for 52 weeks
Intervention Type
Drug
Intervention Name(s)
bitopertin [RO4917838]
Intervention Description
Oral dose level 2, once a day for 52 weeks
Primary Outcome Measure Information:
Title
Efficacy (PANSS negative symptoms factor score)
Time Frame
Week 24
Title
Safety (incidence of adverse events)
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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) of <17 or >40 kg/m2
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Carson
State/Province
California
ZIP/Postal Code
90746
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104-2136
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
City
Omahac
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
City
Jamaica
State/Province
New York
ZIP/Postal Code
11418
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
City
Salvador
State/Province
BA
ZIP/Postal Code
40301-500
Country
Brazil
City
Goiania
State/Province
GO
ZIP/Postal Code
74093-040
Country
Brazil
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-270
Country
Brazil
City
Curitiba
State/Province
PR
ZIP/Postal Code
80240-280
Country
Brazil
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22270-060
Country
Brazil
City
Pelotas
State/Province
RS
ZIP/Postal Code
96030-002
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04044-000
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
City
Medicine Hat
State/Province
Alberta
ZIP/Postal Code
T1B 4E7
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3P1
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4Z3
Country
Canada
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2E2
Country
Canada
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7R 4E2
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3K7
Country
Canada
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 4N4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1N 3M5
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
City
San Miguel
ZIP/Postal Code
8900000
Country
Chile
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
City
Santiago
ZIP/Postal Code
7501126
Country
Chile
City
Santiago
ZIP/Postal Code
8050000
Country
Chile
City
Santiago
ZIP/Postal Code
8320000
Country
Chile
City
Santiago
Country
Chile
City
Valdivia
ZIP/Postal Code
5090000
Country
Chile
City
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Bochum
ZIP/Postal Code
44805
Country
Germany
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Koeln
ZIP/Postal Code
50937
Country
Germany
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
City
München
ZIP/Postal Code
80336
Country
Germany
City
Nürnberg
ZIP/Postal Code
90402
Country
Germany
City
Daugovpils
ZIP/Postal Code
LV-5417
Country
Latvia
City
Jelgava
ZIP/Postal Code
LV-3008
Country
Latvia
City
Liepaja
ZIP/Postal Code
LV 3401
Country
Latvia
City
Kaunas
ZIP/Postal Code
44279
Country
Lithuania
City
Kaunas
ZIP/Postal Code
48259
Country
Lithuania
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
City
Kaunas
ZIP/Postal Code
53136
Country
Lithuania
City
Silute
ZIP/Postal Code
99142
Country
Lithuania
City
Vilnius
ZIP/Postal Code
07156
Country
Lithuania
City
Vilnius
ZIP/Postal Code
10204
Country
Lithuania
City
Assen
ZIP/Postal Code
9400 RA
Country
Netherlands
City
Groningen
ZIP/Postal Code
9700 AB
Country
Netherlands
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
City
Choroszcz
ZIP/Postal Code
16-070
Country
Poland
City
Kielce
ZIP/Postal Code
25-103
Country
Poland
City
Lublin
ZIP/Postal Code
20-015
Country
Poland
City
Lublin
ZIP/Postal Code
20-045
Country
Poland
City
Lublin
ZIP/Postal Code
20-080
Country
Poland
City
Piekary Slaskie
ZIP/Postal Code
41-940
Country
Poland
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
City
Tuszyn
ZIP/Postal Code
95-080
Country
Poland
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
City
Bojnice
ZIP/Postal Code
972 01
Country
Slovakia
City
Bratislava
ZIP/Postal Code
820 07
Country
Slovakia
City
Bratislava
ZIP/Postal Code
851 01
Country
Slovakia
City
Rimavska Sobota
ZIP/Postal Code
97912
Country
Slovakia
City
Svidnik
ZIP/Postal Code
089 01
Country
Slovakia
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Barcelona
ZIP/Postal Code
08304
Country
Spain
City
Barcelona
ZIP/Postal Code
08830
Country
Spain
City
Madrid
ZIP/Postal Code
28009
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
City
Zamora
ZIP/Postal Code
49021
Country
Spain
City
Hualian Town
ZIP/Postal Code
970
Country
Taiwan
City
Kaohsiung
ZIP/Postal Code
80276
Country
Taiwan
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
City
Tainan County
ZIP/Postal Code
717
Country
Taiwan
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
City
Diyarbakir
ZIP/Postal Code
21280
Country
Turkey
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
City
Istanbul
ZIP/Postal Code
34736
Country
Turkey
City
Manisa
ZIP/Postal Code
45010
Country
Turkey
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
City
Donetsk
ZIP/Postal Code
83008
Country
Ukraine
City
Glevakha Kyviv region
ZIP/Postal Code
08631
Country
Ukraine
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
City
Kyiv
ZIP/Postal Code
02660
Country
Ukraine
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
City
Odessa
ZIP/Postal Code
65006
Country
Ukraine
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
28433500
Citation
Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
Results Reference
derived
PubMed Identifier
28117049
Citation
Bugarski-Kirola D, Blaettler T, Arango C, Fleischhacker WW, Garibaldi G, Wang A, Dixon M, Bressan RA, Nasrallah H, Lawrie S, Napieralski J, Ochi-Lohmann T, Reid C, Marder SR. Bitopertin in Negative Symptoms of Schizophrenia-Results From the Phase III FlashLyte and DayLyte Studies. Biol Psychiatry. 2017 Jul 1;82(1):8-16. doi: 10.1016/j.biopsych.2016.11.014. Epub 2016 Dec 15.
Results Reference
derived
Learn more about this trial
A Study of RO4917838 (Bitopertin) in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia (WN25309)
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