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A Study of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (NN25307)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
RO4917838
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

1

2

3

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
June 1, 2015
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01235520
Brief Title
A Study of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (NN25307)
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
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (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 randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 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
595 (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)
RO4917838
Intervention Description
Oral dose level 1, once a day for 52 weeks
Intervention Type
Drug
Intervention Name(s)
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
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
City
Pasadena
State/Province
California
ZIP/Postal Code
91106
Country
United States
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08775
Country
United States
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11366
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18503
Country
United States
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1425AHQ
Country
Argentina
City
Ciudad Autonoma Bs As
ZIP/Postal Code
1117
Country
Argentina
City
Ciudad Autonoma Bs As
ZIP/Postal Code
1405
Country
Argentina
City
Ciudad de Mendoza
ZIP/Postal Code
5500
Country
Argentina
City
Cordoba
ZIP/Postal Code
5003
Country
Argentina
City
Cordoba
ZIP/Postal Code
X5009BIN
Country
Argentina
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
City
Rosario
ZIP/Postal Code
S2000QJI
Country
Argentina
City
Santiago del Estero
ZIP/Postal Code
4200
Country
Argentina
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
City
Barranquilla
Country
Colombia
City
Bello
Country
Colombia
City
Bogota
Country
Colombia
City
Helsinki
ZIP/Postal Code
00250
Country
Finland
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
City
Clermont-ferrand
ZIP/Postal Code
63000
Country
France
City
Dole
ZIP/Postal Code
39100
Country
France
City
Elancourt
ZIP/Postal Code
78990
Country
France
City
Marseille
ZIP/Postal Code
13005
Country
France
City
Strasbourg
ZIP/Postal Code
67091
Country
France
City
Toulon
ZIP/Postal Code
83000
Country
France
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
City
Ahmedabad
ZIP/Postal Code
380006
Country
India
City
Ahmedabad
ZIP/Postal Code
380008
Country
India
City
Ahmedabad
ZIP/Postal Code
380015
Country
India
City
Bangalore
ZIP/Postal Code
560054
Country
India
City
Jaipur
ZIP/Postal Code
302017
Country
India
City
Jaipur
ZIP/Postal Code
302021
Country
India
City
Kalyan
ZIP/Postal Code
421301
Country
India
City
Mangalore
ZIP/Postal Code
575001
Country
India
City
Mangalore
ZIP/Postal Code
575018
Country
India
City
Nashik
ZIP/Postal Code
422101
Country
India
City
Pune
ZIP/Postal Code
411030
Country
India
City
Vadodara
ZIP/Postal Code
390001
Country
India
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
City
Gyeonggi-do
ZIP/Postal Code
425-707
Country
Korea, Republic of
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
City
Jeollabuk-do
ZIP/Postal Code
561-712
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
110-774
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
150-713
Country
Korea, Republic of
City
Mexico
ZIP/Postal Code
05300
Country
Mexico
City
Monterrey
ZIP/Postal Code
64000
Country
Mexico
City
Monterrey
ZIP/Postal Code
64060
Country
Mexico
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
City
San Luis Potosi
ZIP/Postal Code
72818
Country
Mexico
City
Arad
ZIP/Postal Code
310022
Country
Romania
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
City
Cluj-Napoca
ZIP/Postal Code
400012
Country
Romania
City
Lasi
ZIP/Postal Code
700282
Country
Romania
City
Oradea
ZIP/Postal Code
410154
Country
Romania
City
Sibiu
ZIP/Postal Code
550082
Country
Romania
City
Targouiste
ZIP/Postal Code
130081
Country
Romania
City
Kemerovo
ZIP/Postal Code
650036
Country
Russian Federation
City
Lipetsk
ZIP/Postal Code
399313
Country
Russian Federation
City
Moscow Region
ZIP/Postal Code
142601
Country
Russian Federation
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117995
Country
Russian Federation
City
Moscow
ZIP/Postal Code
127083
Country
Russian Federation
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
City
Saint Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
City
Samara
ZIP/Postal Code
443016
Country
Russian Federation
City
Sartatov
ZIP/Postal Code
410028
Country
Russian Federation
City
St Petersbourg
ZIP/Postal Code
190005
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
193167
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
City
Talagi
ZIP/Postal Code
163530
Country
Russian Federation
City
Tomsk
ZIP/Postal Code
634014
Country
Russian Federation
City
Malmö
ZIP/Postal Code
21135
Country
Sweden
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
City
Edinburgh
ZIP/Postal Code
EH10 5HF
Country
United Kingdom
City
London
ZIP/Postal Code
SE5-8AF
Country
United Kingdom
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
City
Oxford
ZIP/Postal Code
OX3 7JX
Country
United Kingdom

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 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (NN25307)

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