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A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
bitopertin [RO4917838] level 1
bitopertin [RO4917838] level 2
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

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

bitopertin [RO4917838] 1

bitopertin [RO4917838] 2

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
NCT01235559
Brief Title
A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)
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
March 2015 (Actual)
Study Completion Date
March 2015 (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
604 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
bitopertin [RO4917838] 1
Arm Type
Experimental
Arm Title
bitopertin [RO4917838] 2
Arm Type
Experimental
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] level 1
Intervention Description
Oral dose level 1, once a day for 52 weeks
Intervention Type
Drug
Intervention Name(s)
bitopertin [RO4917838] level 2
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
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
City
Orange City
State/Province
Florida
ZIP/Postal Code
3273
Country
United States
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46222
Country
United States
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18503
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
City
Bourgas
ZIP/Postal Code
8000
Country
Bulgaria
City
Kazanlak
ZIP/Postal Code
6100
Country
Bulgaria
City
Novi Iskar
ZIP/Postal Code
1282
Country
Bulgaria
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
City
Radnevo
ZIP/Postal Code
6260
Country
Bulgaria
City
Rousse
ZIP/Postal Code
7003
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
City
Baoding
ZIP/Postal Code
071000
Country
China
City
Beijing
ZIP/Postal Code
071000
Country
China
City
Beijing
ZIP/Postal Code
100083
Country
China
City
Beijing
ZIP/Postal Code
100088
Country
China
City
Changsha
ZIP/Postal Code
410011
Country
China
City
Chengdu
ZIP/Postal Code
610041
Country
China
City
GuangzhouGuangdong
ZIP/Postal Code
510370
Country
China
City
Hangzhou
ZIP/Postal Code
310003
Country
China
City
Kunming
ZIP/Postal Code
650032
Country
China
City
Nanjing
ZIP/Postal Code
210029
Country
China
City
Shanghai
ZIP/Postal Code
200030
Country
China
City
Shanghai
ZIP/Postal Code
200065
Country
China
City
Wuhan
ZIP/Postal Code
430060
Country
China
City
Wuxi
ZIP/Postal Code
214151
Country
China
City
Xi'an
ZIP/Postal Code
710032
Country
China
City
Xi'an
ZIP/Postal Code
710061
Country
China
City
Brno
ZIP/Postal Code
602 00
Country
Czech Republic
City
Liberec
ZIP/Postal Code
460 63
Country
Czech Republic
City
Melnik
ZIP/Postal Code
276 01
Country
Czech Republic
City
Plzen
ZIP/Postal Code
312 00
Country
Czech Republic
City
Praha 10
ZIP/Postal Code
100 00
Country
Czech Republic
City
Praha 6
ZIP/Postal Code
160 00
Country
Czech Republic
City
Praha 8 - Bohnice
ZIP/Postal Code
181 03
Country
Czech Republic
City
Sternberk
ZIP/Postal Code
785 01
Country
Czech Republic
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20121
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
City
Chiba
ZIP/Postal Code
272-8516
Country
Japan
City
Funabashi-shi
ZIP/Postal Code
273-8540
Country
Japan
City
Gunma
ZIP/Postal Code
370-2455
Country
Japan
City
Hiroshima-shi
ZIP/Postal Code
733-0864
Country
Japan
City
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
City
Kanzaki-gun
ZIP/Postal Code
842-0192
Country
Japan
City
Kita-Ku
ZIP/Postal Code
114-0024
Country
Japan
City
Kitakyushu-shi
ZIP/Postal Code
807-8556
Country
Japan
City
Kochi-shi
ZIP/Postal Code
780-8535
Country
Japan
City
Koshi-shi
ZIP/Postal Code
861-1116
Country
Japan
City
Kumamoto-shi
ZIP/Postal Code
861-8002
Country
Japan
City
Kurayoshi-shi
ZIP/Postal Code
682-0023
Country
Japan
City
Nagoya-Shi
ZIP/Postal Code
463-0802
Country
Japan
City
Omuta-shi
ZIP/Postal Code
836-0004
Country
Japan
City
Sakai-shi
ZIP/Postal Code
590-0018
Country
Japan
City
Sapporo-shi
ZIP/Postal Code
004-0841
Country
Japan
City
Sapporo-shi
ZIP/Postal Code
006-0816
Country
Japan
City
Sendai-shi
ZIP/Postal Code
983-0836
Country
Japan
City
Shirakawa-shi
ZIP/Postal Code
961-0021
Country
Japan
City
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
City
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
City
Toyama-shi
ZIP/Postal Code
939-8073
Country
Japan
City
Toyoake-shi
ZIP/Postal Code
470-1192
Country
Japan
City
Yokohama-shi
ZIP/Postal Code
223-0062
Country
Japan
City
Yokohama-shi
ZIP/Postal Code
233-0006
Country
Japan
City
Yokohama-shi
ZIP/Postal Code
246-0026
Country
Japan
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation

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

Learn more about this trial

A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)

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