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SchizophreniaPhase 3NCT01192880

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

A Phase 3 study testing Bitopertin and Antipsychotics in people with Schizophrenia, run by Hoffmann-La Roche at 103 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia
What is being tested?
Bitopertin and Antipsychotics
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
625 participants
Where
103 sitesin 7 countries
Study dates
Nov 2010to Jul 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

103 sites in 7 countries.

103 sites in 7 countries

United States27 sites

  • Atlanta Center For Medical Research

    Atlanta, Georgia, 30308

  • Community Clinical Research Inc.

    Austin, Texas, 78754

  • State University of New York at Buffalo; Department of Psychiatry

    Buffalo, New York, 14215

  • Clinical Innovtions Inc

    Costa Mesa, California, 92626

  • Duke University

    Durham, North Carolina, 27705

  • Synergy Clinical Research of Escondido

    Escondido, California, 92025

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Clinical Insights, Inc.

    Glen Burnie, Maryland, 21061

  • San Fernando Mental Health Center

    Granada Hills, California, 91344

  • Indiana University; LaRue Carter Memorial Hospital-Research Unit

    Indianapolis, Indiana, 46222

  • University Hills Clinical Research

    Irving, Texas, 75062

  • Eastside Therapeutic Resource

    Kirkland, Washington, 98033

  • University of California San Diego

    La Jolla, California, 92093

  • Altea Research Institute

    Las Vegas, Nevada, 89102

  • Behavioral Clinical Research Inc.

    Lauderhill, Florida, 33319

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • New York State Psychiatric Institute; Psychiatry Dept of Columbia University

    New York, New York, 10032

  • Keystone Clinical Studies, LLC

    Norristown, Pennsylvania, 19403

  • Excell Research

    Oceanside, California, 92056

  • Medical Research Group of Central Florida

    Orange City, Florida, 3273

  • Berma Research Group

    Plantation, Florida, 33317

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • Lifetree Clinical Research

    Salt Lake City, Utah, 84106

  • Artemis Institute for Clinical Research, LLC

    San Diego, California, 92103

  • Scranton Medical Institutes Llc.

    Scranton, Pennsylvania, 18503

  • Ocean Rheumatology

    Toms River, New Jersey, 08775

  • Collaborative Neuroscience Network Inc.

    Torrance, California, 90502

Other trials in United States

Japan26 sites

  • Kohnodai Hp., National Center for Global Health and Medicine

    Chiba, 272-8516

  • Fukkokai Soubu Hospital

    Funabashi-shi, 273-8540

  • Daiwakai Seimou Hospital

    Gunma, 370-2455

  • Koseikai Kusatsu Hospital

    Hiroshima, 733-0864

  • Hokkaido University Hospital

    Hokkaido, 060-8648

  • NHO Hizen Psychiatric Medical Center

    Kanzaki-gun, 842-0192

  • Sankeikai Nishigahara Hospital

    Kita-ku, 114-0024

  • Hospital of the University of Occupational and Environmental Health,Japan

    Kitakyushu-shi, 807-8556

  • Jinseikai Hosogi Unity Hospital

    Kochi, 780-8535

  • NHO Kikuchi National Hospital

    Koshi-shi, 861-1116

  • Yuge Hospital

    Kumamoto, 861-8002

  • Jinkokai Kurayoshi Hospital

    Kurayoshi-shi, 682-0023

  • NHO Higashiowari Hospital

    Nagoya, 463-0802

  • Shinkokai Shiranui Hospital

    Omuta-shi, 836-0004

  • Asakayama General Hospital

    Sakaishi, 590-0018

  • Tonankai Ashirbetsu Hospital

    Sapporo, 004-0841

  • Sawayamakai Teine Hospital

    Sapporo, 006-0816

  • Tohoku Seishin Hokenkai Aoba Hospital

    Sendai, 983-0836

  • Jisenkai Nanko Psychiatric Institute

    Shirakawa-shi, 961-0021

  • Tokyo Women's Medical University Hospital

    Tokyo, 162-8666

  • National Center Of Neurology And Psychiatry Hospital

    Tokyo, 187-8551

  • Korenkai Minamitoyama Nakagawa Hospital

    Toyama, 939-8073

  • Fujita Health University Hospital

    Toyoake-shi, 470-1192

  • Deep Intention Hiyoshi Hospital

    Yokohama, 223-0062

  • Kanagawa Prefectural Psychiatric Center Kinko Hospital

    Yokohama, 233-0006

  • Yokohama Aihara Hospital

    Yokohama, 246-0026

Other trials in Japan

China18 sites

  • Hebei Mental Health Centre

    Baoding, 071000

  • Beijing Huilongguan Hospital; Department of Psychiatric

    Beijing, 071000

  • Peking University Sixth Hospital; Department of Psychiatry

    Beijing, 100083

  • Beijing An Ding Hosp.Capital Medical University; 5th Clinical Dept Depression Centre

    Beijing, 100088

  • The Second Xiangya Hospital of Central South University

    Changsha, 410011

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Guangzhou Brain Hospital

    GuangzhouGuangdong, 510370

  • The First Affiliated Hospital of College of Medicine, Zhejiang University(First Hospital of Zhejiang

    Hangzhou, 310003

  • The Second Affiliated Hospital of Zhejiang University College

    Hangzhou, 310009

  • The First Affilliated Hospital of Kunming Medical College

    Kunming, 650032

  • Nanjing Brain Hospital

    Nanjing, 210029

  • Shanghai Mental Health Center

    Shanghai, 200030

  • Tongji Hospital of Tongji University

    Shanghai, 200065

  • Renmin Hospital of Wuhan University

    Wuhan, 430060

  • Wuxi Mental Health Center

    Wuxi, 214151

  • The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)

    Xi'an, 710032

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061

  • Xi'an Mental Health Center

    Xi'an, 710061

Other trials in China

Bulgaria8 sites

  • DDPDS Prof Dr Ivan Temkov EOOD

    Burgas, 8000

  • MHAT Dr.Hristo Stambolski EOOD; Psychiatry Ward of Acute Psychotic Disiorders in Severe Stage

    Kazanlak, 6100

  • State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar; First Man Dept. and First Woman Dept.

    Novi Iskar, 1282

  • State Psychiatric Hospital - Pazardzhik AD; Department for active treatment of men and for women

    Pazardzhik, 4400

  • UMHAT Dr Georgi Stranski; EAD; Psychiatry

    Plovdiv, 4002

  • State Psychiatric Hospital Dr. G. Kissiov; 3-d Women Ward 1-st Men Ward

    Radnevo, 6260

  • DDPDIU-Ruse; Men acute department Women acute department

    Rousse, 7003

  • Military Medical Academy- MHAT

    Sofia, 1606

Other trials in Bulgaria

Czechia8 sites

  • Saint Anne s.r.o.

    Brno, 602 00

  • Krajska nemocnice Liberec a.s.

    Liberec, 460 63

  • Psychiatricka ambulance

    Mělník, 276 01

  • A-Shine s.r.o.

    Pilsen, 312 00

  • Clintrial,s.r.o.

    Prague, 100 00

  • Medical Services Prague s.r.o.

    Prague, 160 00

  • Psychiatricke Centrum Praha

    Praha 8 - Bohnice, 181 03

  • CTCenter MaVe s.r.o.

    Sternberk, 785 01

Other trials in Czechia

Italy8 sites

  • Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari; Neuroscienze e Organi di Senso

    Bari, Apulia, 70124

  • Asst Degli Spedali Civili Di Brescia; Servizio di farmacia

    Brescia, Lombardy, 25123

  • Clinica Mangiagalli

    Milan, Lombardy, 20122

  • ASST FATEBENEFRATELLI SACCO; Psichiatria (Fatebenefratelli)

    Milan, Lombardy, 20124

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Campania, 80131

  • Azienda Ospedaliera di Padova

    Padova, Veneto, 35128

  • A.O. Universitaria Pisana; Psichiatria

    Pisa, Tuscany, 56126

  • Azienda Ospedaliero Universitaria Molinette San Giovanni Bat

    Turin, Piedmont, 10126

Other trials in Italy

Russia8 sites

  • Kemerovo Regional Clinical Psychiatric Hospital

    Kemerovo, 650036

  • GUZ Lipetsk Regional psychoneurological Hospital #1; Dispansary Department

    Lipetsk, 399313

  • Institution of RAMS (Mental Health Research Center of RAMS); Psychopharmacology laboratory

    Moscow, 115522

  • Central Moscow Regional Clinical Psychiatric Hospital

    Moscow, 127083

  • City Psychiatric Hospital #2 of St. Nikolay Chudotvorets

    Saint Petersburg, 190121

  • StP SR Psychoneurological Institute n.a.V.M.Bekhterev of MoH

    Saint Petersburg, 192019

  • MHI City Clinical Hospital #2 named after V.I. Razumovsky; Psychiatric

    Sartatov, 410028

  • Arkhangelsk Regional Clinical Psychiatric Hospital

    Talagi, 163530

Other trials in Russia

About this study

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

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.

Conditions
Schizophrenia
Being tested
Placebo, Bitopertin, Antipsychotics
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Participants will receive bitopertin matching placebo once daily for 56 weeks.

  • BitopertinDrug

    Also called RO4917838

    Participants will receive 10 mg or 20 mg of bitopertin.

  • AntipsychoticsDrug

    Participants will continue to receive their stable antipsychotic regiment throughout the study. Study protocol does not specify any particular antipsychotic drug and regimen.

Study groups in NCT01192880
Study groupRoleWhat they receive
Bitopertin 10 mg + AntipsychoticsExperimentalTreatment 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.
Receives: Drug: Bitopertin; Drug: Antipsychotics
Bitopertin 20 mg + AntipsychoticsExperimentalTreatment 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.
Receives: Drug: Bitopertin; Drug: Antipsychotics
PlaceboPlacebo comparatorTreatment 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.
Receives: Drug: Placebo; Drug: Antipsychotics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Symptom Factor Score at Week 24

    Measured: Baseline, Week 24

  2. Percentage of Participants with Adverse Events

    Measured: From baseline up to 24 weeks

Secondary outcomes (8)

  1. Mean Change from Baseline in the Personal and Social Performance (PSP) Total Score at Week 24

    Measured: Baseline, Week 24

  2. Mean Change from Baseline in the PANSS Total Score at Week 24

    Measured: Baseline, Week 24

  3. Mean Change from Baseline in the PANSS Factor Scores at Week 24

    Measured: Baseline, Week 24

  4. Mean Change from Baseline in the PANSS Subscale Scores at Week 24

    Measured: Baseline, Week 24

  5. Percentage of Participants With Response, as Assessed by PANSS Negative Symptom Factor Score

    Measured: Week 24

  6. Percentage of Participants with Response, as Assessed by CGI-I Overall and Negative Symptoms Rating Score

    Measured: Week 24

  7. 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

    Measured: Week 24

  8. Mean Change from Baseline in the CGI-S Overall and Negative Symptoms Rating Score

    Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
625 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01192880
Sponsor's protocol ID
WN25308
Other IDs
2010-020470-42
Status last verified
Feb 2017
First submitted
30 Aug 2010
Last updated
15 Feb 2017
Results posted
No

Publications

  • 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.

    PubMed 28433500

  • 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.

    PubMed 28117049

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bitopertin and Antipsychotics in people with Schizophrenia, run by Hoffmann-La Roche at 103 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States, Japan, China, Bulgaria, Czechia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Symptom Factor Score at Week 24 (time frame: Baseline, Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01192880, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.

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