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A Study to Evaluate Efficacy and Safety of Bitopertin in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Bitopertin
Antipsychotics
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:

  • Based on the screening Structured Clinical Interview for and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) - Clinical Trial (SCID CT), a DSM-IV- Text Revision (DSM-IV-TR) diagnosis of schizophrenia, paranoid, disorganized, residual, undifferentiated or catatonic subtype
  • A score of 40 or greater on the sum of the 14 PANSS negative and disorganized thought factor items (items scored 1-7 for a maximum possible score of 98)
  • A score of 22 or less on the sum of the 8 PANSS positive symptom factor items. The score of the items of P1 (delusions), P3 (hallucinatory behavior), P6 (suspiciousness) and G9 (unusual thought content) meet the following requirements: no more than 2 of the above items have a score of 4; all of the above items score less than 5
  • Clinical stability for 6 months prior to randomization as well as antipsychotic treatment stability for the past 8 weeks at the time of randomization
  • Are at least moderately ill, as defined by Clinical Global Impression - Severity (CGI S) of negative symptoms score more than or equal to (>/=) 4
  • Stable doses of anticholinergic, antidepressive medication for at least 8 weeks prior to randomization is allowed as long as the respective scales cut-off entry criteria are met
  • With the exception of clozapine, participants are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of 2 antipsychotics)
  • Have a caregiver considered reliable by the investigator
  • Female participants who are not either surgically sterile or post-menopausal must agree to use at least one effective forms of contraception from agree to remain sexually abstinent from screening until 90 days after the completion of the study medication

Exclusion Criteria:

  • Evidence that participant has clinically significant, uncontrolled and unstable disorder (for example, cardiovascular, renal, hepatic disorder)
  • Body Mass Index (BMI) of less than (<) 17 or more than (>) 40 kilograms per meter square (kg/m^2)
  • Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS)
  • A severity score of >/=3 on the Parkinsonism item of the Extrapyramidal Symptoms Rating Scale - Abbreviated (ESRS-A) (Clinical Global Impression, Parkinsonism)
  • Positive result on the serum pregnancy test or are breast feeding at screening, or intend to become pregnant during the course of the trial.
  • History of neuroleptic malignant syndrome (NMS)
  • Based on the DSM-IV-TR criteria and screening SCID-CT have: other current DSM-IV-TR Axis I diagnosis; alcohol or substance dependence within 12 months or abuse within 3 months with the exception of nicotine; dementia, delirium and other amnestic disorder per DSM-IV-TR
  • Treated with electroconvulsive therapy (ECT) within 6 months prior to randomization
  • Ever received RO4917838 or another glycine transporter 1 (GLYT 1) inhibitor
  • Require high doses of benzodiazepines (> 4 mg per day lorazepam or equivalent)
  • Have a positive urine drug screen for amphetamines (including 3,4-Methylenedioxymethamphetamine [MDMA]/ecstasy), cocaine, barbiturate, cannabis and/or opiates

Sites / Locations

  • Clinical Innovtions Inc
  • Synergy Clinical Research of Escondido
  • San Fernando Mental Health Center
  • University of California San Diego
  • Excell Research
  • Artemis Institute for Clinical Research, LLC
  • Collaborative Neuroscience Network Inc.
  • Behavioral Clinical Research Inc.
  • University of Miami Miller School of Medicine
  • Medical Research Group of Central Florida
  • Berma Research Group
  • Atlanta Center For Medical Research
  • Indiana University; LaRue Carter Memorial Hospital-Research Unit
  • Clinical Insights, Inc.
  • Precise Research Centers
  • Altea Research Institute
  • Ocean Rheumatology
  • State University of New York at Buffalo; Department of Psychiatry
  • New York State Psychiatric Institute; Psychiatry Dept of Columbia University
  • Finger Lakes Clinical Research
  • Duke University
  • Keystone Clinical Studies, LLC
  • Scranton Medical Institutes Llc.
  • Community Clinical Research Inc.
  • University Hills Clinical Research
  • Lifetree Clinical Research
  • Eastside Therapeutic Resource
  • DDPDS Prof Dr Ivan Temkov EOOD
  • MHAT Dr.Hristo Stambolski EOOD; Psychiatry Ward of Acute Psychotic Disiorders in Severe Stage
  • State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar; First Man Dept. and First Woman Dept.
  • State Psychiatric Hospital - Pazardzhik AD; Department for active treatment of men and for women
  • UMHAT Dr Georgi Stranski; EAD; Psychiatry
  • State Psychiatric Hospital Dr. G. Kissiov; 3-d Women Ward 1-st Men Ward
  • DDPDIU-Ruse; Men acute department Women acute department
  • Military Medical Academy- MHAT
  • Hebei Mental Health Centre
  • Beijing Huilongguan Hospital; Department of Psychiatric
  • Peking University Sixth Hospital; Department of Psychiatry
  • Beijing An Ding Hosp.Capital Medical University; 5th Clinical Dept Depression Centre
  • The Second Xiangya Hospital of Central South University
  • West China Hospital, Sichuan University
  • Guangzhou Brain Hospital
  • The First Affiliated Hospital of College of Medicine, Zhejiang University(First Hospital of Zhejiang
  • The Second Affiliated Hospital of Zhejiang University College
  • The First Affilliated Hospital of Kunming Medical College
  • Nanjing Brain Hospital
  • Shanghai Mental Health Center
  • Tongji Hospital of Tongji University
  • Renmin Hospital of Wuhan University
  • Wuxi Mental Health Center
  • The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  • Xi'an Mental Health Center
  • Saint Anne s.r.o.
  • Krajska nemocnice Liberec a.s.
  • Psychiatricka ambulance
  • A-Shine s.r.o.
  • Clintrial,s.r.o.
  • Medical Services Prague s.r.o.
  • Psychiatricke Centrum Praha
  • CTCenter MaVe s.r.o.
  • Azienda Ospedaliera Universitaria Federico II
  • Asst Degli Spedali Civili Di Brescia; Servizio di farmacia
  • Clinica Mangiagalli
  • ASST FATEBENEFRATELLI SACCO; Psichiatria (Fatebenefratelli)
  • Azienda Ospedaliero Universitaria Molinette San Giovanni Bat
  • Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari; Neuroscienze e Organi di Senso
  • A.O. Universitaria Pisana; Psichiatria
  • Azienda Ospedaliera di Padova
  • Kohnodai Hp., National Center for Global Health and Medicine
  • Fukkokai Soubu Hospital
  • Daiwakai Seimou Hospital
  • Koseikai Kusatsu Hospital
  • Hokkaido University Hospital
  • NHO Hizen Psychiatric Medical Center
  • Sankeikai Nishigahara Hospital
  • Hospital of the University of Occupational and Environmental Health,Japan
  • Jinseikai Hosogi Unity Hospital
  • NHO Kikuchi National Hospital
  • Yuge Hospital
  • Jinkokai Kurayoshi Hospital
  • NHO Higashiowari Hospital
  • Shinkokai Shiranui Hospital
  • Asakayama General Hospital
  • Tonankai Ashirbetsu Hospital
  • Sawayamakai Teine Hospital
  • Tohoku Seishin Hokenkai Aoba Hospital
  • Jisenkai Nanko Psychiatric Institute
  • Tokyo Women's Medical University Hospital
  • National Center Of Neurology And Psychiatry Hospital
  • Korenkai Minamitoyama Nakagawa Hospital
  • Fujita Health University Hospital
  • Deep Intention Hiyoshi Hospital
  • Kanagawa Prefectural Psychiatric Center Kinko Hospital
  • Yokohama Aihara Hospital
  • Kemerovo Regional Clinical Psychiatric Hospital
  • GUZ Lipetsk Regional psychoneurological Hospital #1; Dispansary Department
  • Institution of RAMS (Mental Health Research Center of RAMS); Psychopharmacology laboratory
  • Central Moscow Regional Clinical Psychiatric Hospital
  • MHI City Clinical Hospital #2 named after V.I. Razumovsky; Psychiatric
  • City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
  • StP SR Psychoneurological Institute n.a.V.M.Bekhterev of MoH
  • Arkhangelsk Regional Clinical Psychiatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Bitopertin 10 mg + Antipsychotics

Bitopertin 20 mg + Antipsychotics

Placebo

Arm Description

Treatment Period 1: Participants will receive bitopertin 10 milligrams (mg) tablet orally once daily for 24 weeks. Treatment Period 2: Participants will receive bitopertin 10 mg tablet orally once daily for 28 weeks (up to Study Week 52). After Week 52 there will be a 4-week washout period for at least 50 percent (%) of participants (up to Week 56). Long-Term Extension: After Week 56, participants will enter the long term extension period and continue to receive bitopertin 10 mg tablet orally once daily up to 3 years. In addition, throughout the study, participants will continue their same stable antipsychotic treatment as they were receiving prior to entry in the study.

Treatment Period 1: Participants will receive bitopertin 20 mg tablet orally once daily for 24 weeks. Treatment Period 2: Participants will receive bitopertin 20 mg tablet orally once daily for 28 weeks (up to Study Week 52). After Week 52 there will be a 4-week washout period for at least 50% of participants (up to Week 56). Long-Term Extension: After Week 56, participants will enter the long term extension period and continue to receive bitopertin 20 mg tablet orally once daily up to 3 years. In addition, throughout the study, participants will continue their same stable antipsychotic treatment as they were receiving prior to entry in the study.

Treatment Period 1: Participants will receive bitopertin matching placebo tablet orally once daily for 24 weeks. Treatment Period 2: Participants will receive bitopertin matching placebo tablet orally once daily for 32 weeks (up to Study Week 56). Long-Term Extension: After Week 56, participants will enter the long term extension period and will be switched to (in blinded manner) bitopertin 10 mg tablet orally once daily up to 3 years. In addition, throughout the study, participants will continue their same stable antipsychotic treatment as they were receiving prior to entry in the study.

Outcomes

Primary Outcome Measures

Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Symptom Factor Score at Week 24
Percentage of Participants with Adverse Events

Secondary Outcome Measures

Mean Change from Baseline in the Personal and Social Performance (PSP) Total Score at Week 24
Mean Change from Baseline in the PANSS Total Score at Week 24
Mean Change from Baseline in the PANSS Factor Scores at Week 24
Mean Change from Baseline in the PANSS Subscale Scores at Week 24
Percentage of Participants With Response, as Assessed by PANSS Negative Symptom Factor Score
Percentage of Participants with Response, as Assessed by CGI-I Overall and Negative Symptoms Rating Score
Percentage of Participants with Both At Least 20% Improvement from Baseline in the PANSS Negative Symptom Factor Score and with a CGI-I Negative Symptoms Rating of Either Much or Very Much Improvement
Mean Change from Baseline in the CGI-S Overall and Negative Symptoms Rating Score

Full Information

First Posted
August 30, 2010
Last Updated
February 14, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01192880
Brief Title
A Study to Evaluate Efficacy and Safety of Bitopertin in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia
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
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 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 Phase 3, multi-center, randomized, double blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in participants with persistent, predominant negative symptoms of schizophrenia. Participants, 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
625 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bitopertin 10 mg + Antipsychotics
Arm Type
Experimental
Arm Description
Treatment Period 1: Participants will receive bitopertin 10 milligrams (mg) tablet orally once daily for 24 weeks. Treatment Period 2: Participants will receive bitopertin 10 mg tablet orally once daily for 28 weeks (up to Study Week 52). After Week 52 there will be a 4-week washout period for at least 50 percent (%) of participants (up to Week 56). Long-Term Extension: After Week 56, participants will enter the long term extension period and continue to receive bitopertin 10 mg tablet orally once daily up to 3 years. In addition, throughout the study, participants will continue their same stable antipsychotic treatment as they were receiving prior to entry in the study.
Arm Title
Bitopertin 20 mg + Antipsychotics
Arm Type
Experimental
Arm Description
Treatment Period 1: Participants will receive bitopertin 20 mg tablet orally once daily for 24 weeks. Treatment Period 2: Participants will receive bitopertin 20 mg tablet orally once daily for 28 weeks (up to Study Week 52). After Week 52 there will be a 4-week washout period for at least 50% of participants (up to Week 56). Long-Term Extension: After Week 56, participants will enter the long term extension period and continue to receive bitopertin 20 mg tablet orally once daily up to 3 years. In addition, throughout the study, participants will continue their same stable antipsychotic treatment as they were receiving prior to entry in the study.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment Period 1: Participants will receive bitopertin matching placebo tablet orally once daily for 24 weeks. Treatment Period 2: Participants will receive bitopertin matching placebo tablet orally once daily for 32 weeks (up to Study Week 56). Long-Term Extension: After Week 56, participants will enter the long term extension period and will be switched to (in blinded manner) bitopertin 10 mg tablet orally once daily up to 3 years. In addition, throughout the study, participants will continue their same stable antipsychotic treatment as they were receiving prior to entry in the study.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive bitopertin matching placebo once daily for 56 weeks.
Intervention Type
Drug
Intervention Name(s)
Bitopertin
Other Intervention Name(s)
RO4917838
Intervention Description
Participants will receive 10 mg or 20 mg of bitopertin.
Intervention Type
Drug
Intervention Name(s)
Antipsychotics
Intervention Description
Participants will continue to receive their stable antipsychotic regiment throughout the study. Study protocol does not specify any particular antipsychotic drug and regimen.
Primary Outcome Measure Information:
Title
Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Symptom Factor Score at Week 24
Time Frame
Baseline, Week 24
Title
Percentage of Participants with Adverse Events
Time Frame
From baseline up to 24 weeks
Secondary Outcome Measure Information:
Title
Mean Change from Baseline in the Personal and Social Performance (PSP) Total Score at Week 24
Time Frame
Baseline, Week 24
Title
Mean Change from Baseline in the PANSS Total Score at Week 24
Time Frame
Baseline, Week 24
Title
Mean Change from Baseline in the PANSS Factor Scores at Week 24
Time Frame
Baseline, Week 24
Title
Mean Change from Baseline in the PANSS Subscale Scores at Week 24
Time Frame
Baseline, Week 24
Title
Percentage of Participants With Response, as Assessed by PANSS Negative Symptom Factor Score
Time Frame
Week 24
Title
Percentage of Participants with Response, as Assessed by CGI-I Overall and Negative Symptoms Rating Score
Time Frame
Week 24
Title
Percentage of Participants with Both At Least 20% Improvement from Baseline in the PANSS Negative Symptom Factor Score and with a CGI-I Negative Symptoms Rating of Either Much or Very Much Improvement
Time Frame
Week 24
Title
Mean Change from Baseline in the CGI-S Overall and Negative Symptoms Rating Score
Time Frame
Baseline, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Based on the screening Structured Clinical Interview for and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) - Clinical Trial (SCID CT), a DSM-IV- Text Revision (DSM-IV-TR) diagnosis of schizophrenia, paranoid, disorganized, residual, undifferentiated or catatonic subtype A score of 40 or greater on the sum of the 14 PANSS negative and disorganized thought factor items (items scored 1-7 for a maximum possible score of 98) A score of 22 or less on the sum of the 8 PANSS positive symptom factor items. The score of the items of P1 (delusions), P3 (hallucinatory behavior), P6 (suspiciousness) and G9 (unusual thought content) meet the following requirements: no more than 2 of the above items have a score of 4; all of the above items score less than 5 Clinical stability for 6 months prior to randomization as well as antipsychotic treatment stability for the past 8 weeks at the time of randomization Are at least moderately ill, as defined by Clinical Global Impression - Severity (CGI S) of negative symptoms score more than or equal to (>/=) 4 Stable doses of anticholinergic, antidepressive medication for at least 8 weeks prior to randomization is allowed as long as the respective scales cut-off entry criteria are met With the exception of clozapine, participants are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of 2 antipsychotics) Have a caregiver considered reliable by the investigator Female participants who are not either surgically sterile or post-menopausal must agree to use at least one effective forms of contraception from agree to remain sexually abstinent from screening until 90 days after the completion of the study medication Exclusion Criteria: Evidence that participant has clinically significant, uncontrolled and unstable disorder (for example, cardiovascular, renal, hepatic disorder) Body Mass Index (BMI) of less than (<) 17 or more than (>) 40 kilograms per meter square (kg/m^2) Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS) A severity score of >/=3 on the Parkinsonism item of the Extrapyramidal Symptoms Rating Scale - Abbreviated (ESRS-A) (Clinical Global Impression, Parkinsonism) Positive result on the serum pregnancy test or are breast feeding at screening, or intend to become pregnant during the course of the trial. History of neuroleptic malignant syndrome (NMS) Based on the DSM-IV-TR criteria and screening SCID-CT have: other current DSM-IV-TR Axis I diagnosis; alcohol or substance dependence within 12 months or abuse within 3 months with the exception of nicotine; dementia, delirium and other amnestic disorder per DSM-IV-TR Treated with electroconvulsive therapy (ECT) within 6 months prior to randomization Ever received RO4917838 or another glycine transporter 1 (GLYT 1) inhibitor Require high doses of benzodiazepines (> 4 mg per day lorazepam or equivalent) Have a positive urine drug screen for amphetamines (including 3,4-Methylenedioxymethamphetamine [MDMA]/ecstasy), cocaine, barbiturate, cannabis and/or opiates
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Innovtions Inc
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Synergy Clinical Research of Escondido
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
San Fernando Mental Health Center
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Excell Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Artemis Institute for Clinical Research, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Collaborative Neuroscience Network Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Behavioral Clinical Research Inc.
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Medical Research Group of Central Florida
City
Orange City
State/Province
Florida
ZIP/Postal Code
3273
Country
United States
Facility Name
Berma Research Group
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Atlanta Center For Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Indiana University; LaRue Carter Memorial Hospital-Research Unit
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46222
Country
United States
Facility Name
Clinical Insights, Inc.
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Altea Research Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Ocean Rheumatology
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08775
Country
United States
Facility Name
State University of New York at Buffalo; Department of Psychiatry
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
New York State Psychiatric Institute; Psychiatry Dept of Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Keystone Clinical Studies, LLC
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
Facility Name
Scranton Medical Institutes Llc.
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18503
Country
United States
Facility Name
Community Clinical Research Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
University Hills Clinical Research
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Eastside Therapeutic Resource
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
DDPDS Prof Dr Ivan Temkov EOOD
City
Bourgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
MHAT Dr.Hristo Stambolski EOOD; Psychiatry Ward of Acute Psychotic Disiorders in Severe Stage
City
Kazanlak
ZIP/Postal Code
6100
Country
Bulgaria
Facility Name
State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar; First Man Dept. and First Woman Dept.
City
Novi Iskar
ZIP/Postal Code
1282
Country
Bulgaria
Facility Name
State Psychiatric Hospital - Pazardzhik AD; Department for active treatment of men and for women
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Facility Name
UMHAT Dr Georgi Stranski; EAD; Psychiatry
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
State Psychiatric Hospital Dr. G. Kissiov; 3-d Women Ward 1-st Men Ward
City
Radnevo
ZIP/Postal Code
6260
Country
Bulgaria
Facility Name
DDPDIU-Ruse; Men acute department Women acute department
City
Rousse
ZIP/Postal Code
7003
Country
Bulgaria
Facility Name
Military Medical Academy- MHAT
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Hebei Mental Health Centre
City
Baoding
ZIP/Postal Code
071000
Country
China
Facility Name
Beijing Huilongguan Hospital; Department of Psychiatric
City
Beijing
ZIP/Postal Code
071000
Country
China
Facility Name
Peking University Sixth Hospital; Department of Psychiatry
City
Beijing
ZIP/Postal Code
100083
Country
China
Facility Name
Beijing An Ding Hosp.Capital Medical University; 5th Clinical Dept Depression Centre
City
Beijing
ZIP/Postal Code
100088
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
ZIP/Postal Code
410011
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Guangzhou Brain Hospital
City
GuangzhouGuangdong
ZIP/Postal Code
510370
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University(First Hospital of Zhejiang
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University College
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
The First Affilliated Hospital of Kunming Medical College
City
Kunming
ZIP/Postal Code
650032
Country
China
Facility Name
Nanjing Brain Hospital
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Shanghai Mental Health Center
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Tongji Hospital of Tongji University
City
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
ZIP/Postal Code
430060
Country
China
Facility Name
Wuxi Mental Health Center
City
Wuxi
ZIP/Postal Code
214151
Country
China
Facility Name
The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
City
Xi'an
ZIP/Postal Code
710032
Country
China
Facility Name
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Facility Name
Xi'an Mental Health Center
City
Xi'an
ZIP/Postal Code
710061
Country
China
Facility Name
Saint Anne s.r.o.
City
Brno
ZIP/Postal Code
602 00
Country
Czech Republic
Facility Name
Krajska nemocnice Liberec a.s.
City
Liberec
ZIP/Postal Code
460 63
Country
Czech Republic
Facility Name
Psychiatricka ambulance
City
Melnik
ZIP/Postal Code
276 01
Country
Czech Republic
Facility Name
A-Shine s.r.o.
City
Plzen
ZIP/Postal Code
312 00
Country
Czech Republic
Facility Name
Clintrial,s.r.o.
City
Praha 10
ZIP/Postal Code
100 00
Country
Czech Republic
Facility Name
Medical Services Prague s.r.o.
City
Praha 6
ZIP/Postal Code
160 00
Country
Czech Republic
Facility Name
Psychiatricke Centrum Praha
City
Praha 8 - Bohnice
ZIP/Postal Code
181 03
Country
Czech Republic
Facility Name
CTCenter MaVe s.r.o.
City
Sternberk
ZIP/Postal Code
785 01
Country
Czech Republic
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Asst Degli Spedali Civili Di Brescia; Servizio di farmacia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Clinica Mangiagalli
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
ASST FATEBENEFRATELLI SACCO; Psichiatria (Fatebenefratelli)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20124
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Molinette San Giovanni Bat
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari; Neuroscienze e Organi di Senso
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Facility Name
A.O. Universitaria Pisana; Psichiatria
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Kohnodai Hp., National Center for Global Health and Medicine
City
Chiba
ZIP/Postal Code
272-8516
Country
Japan
Facility Name
Fukkokai Soubu Hospital
City
Funabashi-shi
ZIP/Postal Code
273-8540
Country
Japan
Facility Name
Daiwakai Seimou Hospital
City
Gunma
ZIP/Postal Code
370-2455
Country
Japan
Facility Name
Koseikai Kusatsu Hospital
City
Hiroshima-shi
ZIP/Postal Code
733-0864
Country
Japan
Facility Name
Hokkaido University Hospital
City
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
NHO Hizen Psychiatric Medical Center
City
Kanzaki-gun
ZIP/Postal Code
842-0192
Country
Japan
Facility Name
Sankeikai Nishigahara Hospital
City
Kita-Ku
ZIP/Postal Code
114-0024
Country
Japan
Facility Name
Hospital of the University of Occupational and Environmental Health,Japan
City
Kitakyushu-shi
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Jinseikai Hosogi Unity Hospital
City
Kochi-shi
ZIP/Postal Code
780-8535
Country
Japan
Facility Name
NHO Kikuchi National Hospital
City
Koshi-shi
ZIP/Postal Code
861-1116
Country
Japan
Facility Name
Yuge Hospital
City
Kumamoto-shi
ZIP/Postal Code
861-8002
Country
Japan
Facility Name
Jinkokai Kurayoshi Hospital
City
Kurayoshi-shi
ZIP/Postal Code
682-0023
Country
Japan
Facility Name
NHO Higashiowari Hospital
City
Nagoya-Shi
ZIP/Postal Code
463-0802
Country
Japan
Facility Name
Shinkokai Shiranui Hospital
City
Omuta-shi
ZIP/Postal Code
836-0004
Country
Japan
Facility Name
Asakayama General Hospital
City
Sakai-shi
ZIP/Postal Code
590-0018
Country
Japan
Facility Name
Tonankai Ashirbetsu Hospital
City
Sapporo-shi
ZIP/Postal Code
004-0841
Country
Japan
Facility Name
Sawayamakai Teine Hospital
City
Sapporo-shi
ZIP/Postal Code
006-0816
Country
Japan
Facility Name
Tohoku Seishin Hokenkai Aoba Hospital
City
Sendai-shi
ZIP/Postal Code
983-0836
Country
Japan
Facility Name
Jisenkai Nanko Psychiatric Institute
City
Shirakawa-shi
ZIP/Postal Code
961-0021
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
National Center Of Neurology And Psychiatry Hospital
City
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Facility Name
Korenkai Minamitoyama Nakagawa Hospital
City
Toyama-shi
ZIP/Postal Code
939-8073
Country
Japan
Facility Name
Fujita Health University Hospital
City
Toyoake-shi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Deep Intention Hiyoshi Hospital
City
Yokohama-shi
ZIP/Postal Code
223-0062
Country
Japan
Facility Name
Kanagawa Prefectural Psychiatric Center Kinko Hospital
City
Yokohama-shi
ZIP/Postal Code
233-0006
Country
Japan
Facility Name
Yokohama Aihara Hospital
City
Yokohama-shi
ZIP/Postal Code
246-0026
Country
Japan
Facility Name
Kemerovo Regional Clinical Psychiatric Hospital
City
Kemerovo
ZIP/Postal Code
650036
Country
Russian Federation
Facility Name
GUZ Lipetsk Regional psychoneurological Hospital #1; Dispansary Department
City
Lipetsk
ZIP/Postal Code
399313
Country
Russian Federation
Facility Name
Institution of RAMS (Mental Health Research Center of RAMS); Psychopharmacology laboratory
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Central Moscow Regional Clinical Psychiatric Hospital
City
Moscow
ZIP/Postal Code
127083
Country
Russian Federation
Facility Name
MHI City Clinical Hospital #2 named after V.I. Razumovsky; Psychiatric
City
Sartatov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
StP SR Psychoneurological Institute n.a.V.M.Bekhterev of MoH
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Arkhangelsk Regional Clinical Psychiatric Hospital
City
Talagi
ZIP/Postal Code
163530
Country
Russian Federation

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 to Evaluate Efficacy and Safety of Bitopertin in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia

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