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A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25306)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
bitopertin [RO4917838]
bitopertin [RO4917838]
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Diagnosis of schizophrenia
  • Clinical stability for 16 weeks (4 months) prior to randomization
  • Antipsychotic treatment stability for the past 12 weeks prior to randomization
  • With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics)

Exclusion Criteria:

  • Has treatment resistant schizophrenia as judged by the treating physician OR have failed two trials
  • Evidence that patient has clinically significant uncontrolled or unstable medical disorder (e.g. cardiovascular, renal hepatic, gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease)
  • Patient has a body mass index (BMI) of <17 or >40 kg/m2, respectively)
  • Diagnosis of mental retardation or severe organic brain syndromes
  • In the investigator's judgment, a significant risk of suicide or violent behavior

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Bitopertin oral dose level 1

Bitopertin oral dose level 2

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS)
Safety (incidence of adverse events)

Secondary Outcome Measures

Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS)
Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale
Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale
Safety (incidence of adverse events)

Full Information

First Posted
October 22, 2010
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01235585
Brief Title
A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25306)
Official Title
Phase III, Multi-center, Randomized, 12-week, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 40-week Double-blind, Parallel-group, Placebo-controlled 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
September 2014 (Actual)
Study Completion Date
September 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 randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally controlled 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
597 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bitopertin oral dose level 1
Arm Type
Experimental
Arm Title
Bitopertin oral dose level 2
Arm Type
Experimental
Arm Title
Placebo
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
Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS)
Time Frame
Change from baseline to Week 12
Title
Safety (incidence of adverse events)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS)
Time Frame
Change from baseline to Week 12
Title
Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale
Time Frame
Change from baseline to Week 12
Title
Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale
Time Frame
Change from baseline to Week 12
Title
Safety (incidence of adverse events)
Time Frame
60 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients, >/= 18 years of age Diagnosis of schizophrenia Clinical stability for 16 weeks (4 months) prior to randomization Antipsychotic treatment stability for the past 12 weeks prior to randomization With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics) Exclusion Criteria: Has treatment resistant schizophrenia as judged by the treating physician OR have failed two trials Evidence that patient has clinically significant uncontrolled or unstable medical disorder (e.g. cardiovascular, renal hepatic, gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease) Patient has a body mass index (BMI) of <17 or >40 kg/m2, respectively) Diagnosis of mental retardation or severe organic brain syndromes In the investigator's judgment, a significant risk of suicide or violent behavior
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
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
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
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
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
Bothell
State/Province
Washington
ZIP/Postal Code
98011
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
Itapira
State/Province
SP
ZIP/Postal Code
13970-905
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
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
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
ZIP/Postal Code
8900000
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
80336
Country
Germany
City
Muenchen
ZIP/Postal Code
81675
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
20-045
Country
Poland
City
Lublin
ZIP/Postal Code
20-080
Country
Poland
City
Lublin
ZIP/Postal Code
20-582
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
Trnava
ZIP/Postal Code
917 75
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
34000
Country
Turkey
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
City
Istanbul
ZIP/Postal Code
34736
Country
Turkey
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
City
Manisa
ZIP/Postal Code
45030
Country
Turkey
City
Mersin
ZIP/Postal Code
33169
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
Odesa
ZIP/Postal Code
65117
Country
Ukraine
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
27816567
Citation
Bugarski-Kirola D, Iwata N, Sameljak S, Reid C, Blaettler T, Millar L, Marques TR, Garibaldi G, Kapur S. Efficacy and safety of adjunctive bitopertin versus placebo in patients with suboptimally controlled symptoms of schizophrenia treated with antipsychotics: results from three phase 3, randomised, double-blind, parallel-group, placebo-controlled, multicentre studies in the SearchLyte clinical trial programme. Lancet Psychiatry. 2016 Dec;3(12):1115-1128. doi: 10.1016/S2215-0366(16)30344-3. Epub 2016 Nov 2.
Results Reference
derived

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A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25306)

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