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SchizophreniaPhase 3NCT01192867

A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)

A Phase 3 study testing RO4917838 in people with Schizophrenia, run by Hoffmann-La Roche at 122 sites in 14 countries.

Completed

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

Official record
Search all trials

Trial summary

This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 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?
RO4917838
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
629 participants
Where
122 sitesin 14 countries
Study dates
11 Dec 2010to 26 May 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

  • Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype
  • Predominant negative symptoms
  • With the exception of clozapine, participants are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics)

Who cannot join

  • Evidence that participant has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
  • Body Mass Index (BMI) of less than (<) 17 or greater 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 or greater on the Parkinsonism item of the Exrapyramidal Symptoms Rating Scale-Abbreviated (ESRS-A) (Clinical Global Impression, Parkinsonism)

Trial locations and contacts

122 sites in 14 countries.

122 sites in 14 countries

United States27 sites

  • Raymond G. Murphy VA Medical Center

    Albuquerque, New Mexico, 87108

  • Advanced Research Center Inc.

    Anaheim, California, 92805

  • Claghorn-Lesem Research Clinic, Inc.

    Bellaire, Texas, 77401

  • Pacific Institute of Medical Sciences

    Bothell, Washington, 98011

  • Behavioral Medical Research of Brooklyn

    Brooklyn, New York, 11201

  • Comprehensive Clinical Development- Cerritos CA

    Cerritos, California, 90703

  • UC Health Clinical Trials Office

    Cincinnati, Ohio, 45267

  • FutureSearch Clinical Trials, LP

    Dallas, Texas, 75231

  • Pillar Clinical Research LLC

    Dallas, Texas, 75243

  • Diligent Clinical Trials Inc

    Downey, California, 90241

  • Comprehensive NeuroScience

    Fresh Meadows, New York, 11366

  • Clinical Insights, Inc.

    Glen Burnie, Maryland, 21061

  • University of Iowa College of Medicine; Psychiatry Research

    Iowa City, Iowa, 52242

  • Eastside Therapeutic Resource

    Kirkland, Washington, 98033

  • Care Research Center

    La Palma, California, 90623

  • K&S Professional Research Services LLC

    Little Rock, Arkansas, 72201

  • Northwest Behavioral Research Center

    Marietta, Georgia, 30060

  • Pharmax Research Clinic Inc.

    Miami, Florida, 33126

  • American Medical Research, Inc

    Oak Brook, Illinois, 60523

  • Pasadena Research Institute

    Pasadena, California, 91106

  • Belmont Center for Comprehensive Treatment; Research

    Philadelphia, Pennsylvania, 19131

  • CNRI - Los Angeles, LLC

    Pico Rivera, California, 90660

  • North Carolina Psychiatric Research Center

    Raleigh, North Carolina, 27603

  • St Louis Clinical Trials

    St Louis, Missouri, 63141

  • Family Psychiatry of the Woodlands P.A.

    The Woodlands, Texas, 77381

  • Ocean Rheumatology

    Toms River, New Jersey, 08775

  • CRI Worldwide LLC

    Willingboro, New Jersey, 08046

Other trials in United States

Russia18 sites

  • Kemerovo Regional Clinical Psychiatric Hospital

    Kemerovo, 650036

  • GUZ Lipetsk Regional psychoneurological Hospital #1; Dispansary Department

    Lipetsk, 399313

  • Scientifically Research Institute of Psychiatry of Ministry of Health of the Russian Federation

    Moscow, 107076

  • Institution of RAMS (Mental Health Research Center of RAMS)

    Moscow, 115522

  • Federal State Institution Moscow SRI of Psychiatry of Minzdravsocrazvitia

    Moscow, 117995

  • Central Moscow Regional Clinical Psychiatric Hospital

    Moscow, 127083

  • Moscow Region Psychiatric Hospital #5

    Moscow Region, 142601

  • City Clinical Psychiatry Hospital #1

    Nizhny Novgorod, 603155

  • St. Petersburg State Healthcare Institution

    Saint Petersburg, 190005

  • City Psychiatric Hospital #2 of St. Nikolay Chudotvorets

    Saint Petersburg, 190121

  • Saint Petersburg Psychoneurological Research Institute of Roszdrav n.a. Bekhterev

    Saint Petersburg, 192019

  • St. Petersburg GUZ City Psychiatric Hospital #6

    Saint Petersburg, 193167

  • Military Medical Academy

    Saint Petersburg, 194044

  • St. Petersburg State Healthcare Institution "City Mental Hospital #3; I.I. Skvortsov-Stepanov

    Saint Petersburg, 197341

  • Samara Psychiatric Hospital

    Samara, 443016

  • Mhi City Clinical Hospital #2 Named After v.i. Razumousky

    Sartatov, 410028

  • Arkhangelsk Regional Clinical Psychiatric Hospital

    Talagi, 163530

  • Tomsk Clinical Psychiatric Hospital

    Tomsk, 634014

Other trials in Russia

Argentina13 sites

  • Centro SERES

    Buenos Aires, 1425

  • Fundacion para el Estudio y Tratamiento des las Enfi Mentales

    Buenos Aires, C1425AHQ

  • Mulieris

    CABA, C1022AAO

  • Facene Fund.Argentina Contra Enferm.Neur.Del Envejecimiento

    Ciudad Autonoma Bs As, 1117

  • Instituto Nacional de Psicopatologia

    Ciudad Autonoma Bs As, 1405

  • Instituto DAMIC - Fundación Rusculleda

    Córdoba, 5003

  • Sanatorio Prof.Leon.S.Morra S.A

    Córdoba, X5009BIN

  • Instituto de Neurociencias San Agustín S.A.

    La Plata, 1900

  • Centro de Psiquiatria Biologica Professor Julio J. Herrera; Psiquiatria

    Mendoza, 5500

  • Resolution Psicopharmacology Research Institute

    Mendoza, 5500

  • Centro de Asistencia e Investigación en Neurociencias

    Mendoza

  • CIAP - Centro de Investigacion y Asistencia en Psiquiatria

    Rosario, S2000QJI

  • Centro de Investigacion Clinica Farmacologica en Psiquiatria

    Santiago del Estero, 4200

Other trials in Argentina

India10 sites

  • Samvedna Hospitals; Samvedana Psychiatry and Sex Therapy Hospital

    Ahmedabad, 380006

  • Sneh Clinic

    Ahmedabad, 380008

  • Gujarat Institute of Psychological Research (GIPS)

    Ahmedabad, 380015

  • Mental Health Care & Research

    Jaipur, 302017

  • R. K.Yadav Memorial Mental Health & De-Addiction Hospital

    Jaipur, 302021

  • Manav Neuropsychiatric Hospital Pvt. Ltd.

    Kalyān, 421301

  • Kasturba Medical College & Hospital

    Mangalore, 575001

  • K. S. Hegde Medical Academy

    Mangalore, 575018

  • Poona Hospital and Research Centre

    Pune, 411030

  • Brij Psychiatry Hospital & Muskaan Research Centre; Maanav Health Foundation

    Vadodara, 390001

Other trials in India

Romania10 sites

  • Spitalul Clinic Judetean Arad; Departamentul de Psihiatrie

    Arad, 310022

  • Spit Univ Urgenta Militar Dr. Carol Davila; Sectia Psihiatrie

    Bucharest, 010825

  • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Clinical III Psihiatrie

    Bucharest, 041914

  • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Comunitara si Reintegrare Psihosociala

    Bucharest, 041914

  • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Sectia Clinica XIII Psihiatrie

    Bucharest, 041914

  • Spitalul Clinic Judetean de Urgenta Cluj; Sectia Clinica de Psihiatrie III

    Cluj-Napoca, 400012

  • Spitalul Universitar de Psihiatrie Socola

    Lasi, 700282

  • Spitalul Clinic Municipal Dr. Gavril Curteanu; Sectia Clinica Psihiatrie I

    Oradea, 410154

  • Spitalul de Psihiatrie Dr. Gh. Preda Sibiu;CSM Adulti Sibiu

    Sibiu, 550082

  • Cabinet Medical S.C. Lorentina 2102 S.R.L.; Psihiatrie

    Targouiste, 130081

Other trials in Romania

South Korea9 sites

  • Inje University Busan Paik Hospital

    Busan, 47392

  • Chonnam National University Hospital

    Gwangju, 61469

  • Korea University Ansan Hospital

    Gyeonggi-do, 15355

  • Inha University Hospital

    Incheon, 22332

  • Gil Hospital. Gachon University

    Incheon, 405-760

  • Chonbuk National Uni Hospital

    Jeollabuk-do, 561-712

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • The Catholic University of Korea St.Mary's Hospital

    Seoul, 150-713

Other trials in South Korea

Hungary8 sites

  • Dr. Kenessey Albert Hospital; Psychiatry I.

    Balassagyarmat, 2660

  • Fov.Onk.Szt Janos Korh. E-Budai Egyesitett Korhazai; Pszichiatriaci rehabilitacio

    Budapest, 1032

  • Semmelweis Egyetem AOK; Pszichiatriai es Pszichoterapias Klinika

    Budapest, 1082

  • Fovarosi Onkormanyzat Nyiro Gyula Korhaza; Pszichatria II

    Budapest, 1135

  • Fovarosi Onkormanyzat Nyiro Gyula Korhaza; Pszichiatria I.

    Budapest, 1135

  • UNO Medical Trials Kft.

    Budapest, 1135

  • Petz Aladar Megyei Oktato Korhaz; Pszichiatria I.

    Győr, 9024

  • Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

    Gyula, 5703

Other trials in Hungary

France7 sites

  • Centre Hospitalier Universitaire Caen; Pôle Psychiatrie - Addictologie

    Caen, 14033

  • CHU Gabriel Montpied; Service de Psychiatrie

    Clermont-Ferrand, 63000

  • Centre Hospitalier Specialise du Jura

    Dole, 39100

  • Cabinet Médical Ambroise Paré

    Élancourt, 78990

  • Hôpital de la Conception; Pôle Psychiatrique Centre

    Marseille, 13005

  • CHU Strasbourg Nouvel Hôpital Civil;Service de Psychiatrie I

    Strasbourg, 67091

  • Hopital Chalucet; Unite de Psychiatrie

    Toulon, 83000

Other trials in France

Mexico5 sites

  • Arete Proycectos y Administracion S.C

    México, 05300

  • Centro de Investigacion Medica S.C; Hospital Santa Cecilia de Monterrey S.A. de C.V.

    Monterrey, 64000

  • Medikalink

    Monterrey, 64060

  • Instituto de informacion e investigacion en salud mental AC

    Monterrey, 64710

  • Hospital Lomas de San Luis Internacional

    San Luis Potosí City, 72818

Other trials in Mexico

Australia4 sites

  • Monash Medical Centre-Clayton Campus; School of Psychology and Psychiatry

    Clayton, Victoria, 3168

  • Frankston Hospital; Mental Health Service

    Frankston, Victoria, 3199

  • The Alfred Hospital; Monash Alfred Psychiatry Research Centre (MAP-RC)

    Melbourne, Victoria, 3004

  • Westmead Hospital; Department of Psychiatry

    Westmead, New South Wales, 2145

Other trials in Australia

Sweden4 sites

  • Integrerad Närsjukvård i Malmö

    Malmö, 21135

  • Karolinska Universitetssjukhuset Huddinge, Psykiatri Sydväst

    Stockholm, 14186

  • Danderyds Sjukhus AB; PRIMA Vuxenpsykiatri

    Stockholm, 18288

  • Akademiska Sjukhuset; Psykosvård och rättspsykiatrisk vård

    Uppsala, 75185

Other trials in Sweden

Colombia3 sites

  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA

    Barranquilla

  • E.S.E. Hospital Mental de Antioquia

    Bello

  • Centro de Investigaciones del Sistema Nervioso Limitada - Gr

    Bogotá

Other trials in Colombia

United Kingdom3 sites

  • Royal Edinburgh Hospital; Psychiatry

    Edinburgh, EH10 5HF

  • Institute of Pyschiatry

    London, SE5-8AF

  • Wareneford Hospital

    Oxford, OX3 7JX

Other trials in United Kingdom

Finland1 site

  • Privater

    Kuopio, 70100

Other trials in Finland

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 multi-center, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 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 56 weeks (treatment period 1 of 24 weeks and treatment period 2 of 32 weeks), followed by an optional treatment extension for up to 3 years. After 52 weeks, participants who were originally randomized to an active treatment will be randomly assigned to receive either placebo or continue on the originally assigned study treatment for 4 weeks washout period (Week 52 to Week 56) for the assessment of potential withdrawal effects in a blinded manner using participants staying on active treatment as a control. Participants initially randomized to placebo will remain on placebo. After 56 weeks, participants who were switched to placebo in the washout period will return to their blinded, active treatment arm.

Conditions
Schizophrenia
Being tested
Placebo, RO4917838, Antipshychotics (Standard of Care)
Medical subject headings
Schizophrenia

What participants receive

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

  • PlaceboDrug

    Placebo will be administered orally QD for 56 weeks

  • RO4917838Drug

    RO4917838 will be administered orally at 20 or 10 mg QD for 56 weeks.

  • Antipshychotics (Standard of Care)Drug

    Participants will continue to receive their stable antipshychotic as standard of care based on their prescription up to Week 56.

Study groups in NCT01192867
Study groupRoleWhat they receive
RO4917838 20 milligrams (mg)ExperimentalParticipants, on stable antipsychotics, will receive RO4917838 orally at 20 mg once daily (QD) up to 56 weeks followed by an optional treatment extension for up to 3 years.
Receives: Drug: RO4917838; Drug: Antipshychotics (Standard of Care)
RO4917838 10 mgExperimentalParticipants, on stable antipsychotics, will receive RO4917838 orally at 10 mg QD up to 56 weeks followed by an optional treatment extension for up to 3 years.
Receives: Drug: RO4917838; Drug: Antipshychotics (Standard of Care)
PlaceboPlacebo comparatorParticipants, on stable antipsychotics, will receive RO4917838 matching placebo orally QD up to 56 weeks.
Receives: Drug: Placebo; Drug: Antipshychotics (Standard of Care)

What is being measured

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

  1. Change From Baseline in the Positive and Negative Symptoms Scales (PANSS) Negative Symptoms Factor Score at Week 24 (All-Participant Population)

    Measured: Baseline, Week 24

  2. Percentage of Participants With Adverse Events (All-Participant Population)

    Measured: Week 24

Secondary outcomes (27)

  1. Change From Baseline in the PANSS Negative Symptoms Factor Score at Week 24 (Complement Factor H Related Protein 1 High [CFHR1-High] Subgroup Population)

    Measured: Baseline, Week 24

  2. Change From Baseline in the Personal and Social Performance (PSP) Total Score at Week 24 (All-Participant Population)

    Measured: Baseline, Week 24

  3. Change From Baseline in the PSP Total Score at Week 24 (CFHR1-High Subgroup Population)

    Measured: Baseline, Week 24

  4. Change From Baseline in the PANSS Total Score at Week 24 (All-Participant Population)

    Measured: Baseline, Week 24

  5. Change From Baseline in the PANSS Total Score at Week 24 (CFHR1-High Subgroup Population)

    Measured: Baseline, Week 24

  6. Change From Baseline in the PANSS Factor Score at Week 24 (All-Participant Population)

    Measured: Baseline, Week 24

  7. Change From Baseline in the PANSS Factor Score at Week 24 (CFHR1-High Subgroup Population)

    Measured: Baseline, Week 24

  8. Change From Baseline in the PANSS Subscale Scores at Week 24 (All-Participant Population)

    Measured: Baseline, Week 24

  9. Change From Baseline in the PANSS Subscale Scores at Week 24 (CFHR1-High Subgroup Population)

    Measured: Baseline, Week 24

  10. Percentage of Participants Who Have at least 20 Percent (%) Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 (All-Participant Population)

    Measured: Baseline, Week 24

  11. Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 (CFHR1-High Subgroup Population)

    Measured: Baseline, Week 24

  12. Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score for Two out of Three Assessments During 24 Weeks (All-Participant Population)

    Measured: Baseline up to Week 24

  13. Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score for Two out of Three Assessments During 24 Weeks (CFHR1-High Subgroup Population)

    Measured: Baseline up to Week 24

  14. Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on Clinical Global Impression - Improvement (CGI-I) Score (All-Participant Population)

    Measured: Baseline, Week 24

  15. Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score (CFHR1 Subgroup Population)

    Measured: Baseline, Week 24

  16. Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score for Two out of Three Assessments During 24 Weeks (All-Participant Population)

    Measured: Baseline up to Week 24

  17. Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score for Two out of Three Assessments During 24 Weeks (CFHR1 Subgroup Population)

    Measured: Baseline up to Week 24

  18. Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score (All-Participant Population)

    Measured: Baseline, Week 24

  19. Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score (CFHR1 Subgroup Population)

    Measured: Baseline, Week 24

  20. Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score for Two out of Three Assessments During 24 Weeks (All-Participant Population)

    Measured: Baseline up to Week 24

  21. Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score for Two out of Three Assessments During 24 Weeks (CFHR1 Subgroup Population)

    Measured: Baseline up to Week 24

  22. Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 and Improvement in the Negative Symptoms Based on CGI-I Negative Symptoms Score (All-Participant Population)

    Measured: Baseline, Week 24

  23. Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 and Improvement in the Negative Symptoms Based on CGI-I Negative Symptoms Score (CFHR1 Subgroup Population)

    Measured: Baseline, Week 24

  24. Change From Baseline in Severity of Illness Based on Clinical Global Impression - Severity (CGI-S) Overall Score (All-Participant Population)

    Measured: Baseline, Week 24

  25. Change From Baseline in Severity of Illness Based on CGI-S Overall Score (CFHR1 Subgroup Population)

    Measured: Baseline, Week 24

  26. Change From Baseline in Severity of Illness Based on CGI-S Negative Symptoms Score (All-Participant Population)

    Measured: Baseline, Week 24

  27. Change From Baseline in Severity of Illness Based on CGI-S Negative Symptoms Score (CFHR1 Subgroup Population)

    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 start11 Dec 2010
  3. Primary completion26 May 2014
  4. Study completion26 May 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
629 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01192867
Sponsor's protocol ID
NN25310
Other IDs
2010-020370-42
Status last verified
Jun 2017
First submitted
30 Aug 2010
Last updated
26 Jun 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 RO4917838 in people with Schizophrenia, run by Hoffmann-La Roche at 122 sites in 14 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 3 inclusion and 4 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 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in United States, Russia, Argentina, India, Romania and 9 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?

Change From Baseline in the Positive and Negative Symptoms Scales (PANSS) Negative Symptoms Factor Score at Week 24 (All-Participant Population) (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 NCT01192867, 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 26 Jun 2017.

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