AzTrials
AzTrials

SchizophreniaPhase 3NCT01235520

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

A Phase 3 study testing RO4917838 in people with Schizophrenia, run by Hoffmann-La Roche at 121 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 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. 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
595 participants
Where
121 sitesin 14 countries
Study dates
Jan 2011to 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

  • 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)

Who cannot join

  • 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

Trial locations and contacts

121 sites in 14 countries.

121 sites in 14 countries

United States30 sites

  • Study site

    Albuquerque, New Mexico, 87108

  • Study site

    Bellaire, Texas, 77401

  • Study site

    Brooklyn, New York, 11201

  • Study site

    Buena Park, California, 90620

  • Study site

    Cerritos, California, 90703

  • Study site

    Cincinnati, Ohio, 45206

  • Study site

    Dallas, Texas, 75231

  • Study site

    Dallas, Texas, 75243

  • Study site

    Downey, California, 90241

  • Study site

    Fresh Meadows, New York, 11366

  • Study site

    Glen Burnie, Maryland, 21061

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Kirkland, Washington, 98033

  • Study site

    La Palma, California, 90623

  • Study site

    Las Vegas, Nevada, 89102

  • Study site

    Little Rock, Arkansas, 72201

  • Study site

    Little Rock, Arkansas, 72211

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Miami, Florida, 33126

  • Study site

    Miami, Florida, 33136

  • Study site

    New York, New York, 10035

  • Study site

    Oak Brook, Illinois, 60523

  • Study site

    Pasadena, California, 91106

  • Study site

    Philadelphia, Pennsylvania, 19131

  • Study site

    Pico Rivera, California, 90660

  • Study site

    Raleigh, North Carolina, 27603

  • Study site

    Scranton, Pennsylvania, 18503

  • Study site

    The Woodlands, Texas, 77381

  • Study site

    Toms River, New Jersey, 08775

  • Study site

    Willingboro, New Jersey, 08046

Other trials in United States

Russia18 sites

  • Study site

    Kemerovo, 650036

  • Study site

    Lipetsk, 399313

  • Study site

    Moscow, 107076

  • Study site

    Moscow, 115522

  • Study site

    Moscow, 117995

  • Study site

    Moscow, 127083

  • Study site

    Moscow Region, 142601

  • Study site

    Nizhny Novgorod, 603155

  • Study site

    Saint Petersburg, 190005

  • Study site

    Saint Petersburg, 190121

  • Study site

    Saint Petersburg, 192019

  • Study site

    Saint Petersburg, 193167

  • Study site

    Saint Petersburg, 194044

  • Study site

    Saint Petersburg, 197341

  • Study site

    Samara, 443016

  • Study site

    Sartatov, 410028

  • Study site

    Talagi, 163530

  • Study site

    Tomsk, 634014

Other trials in Russia

India12 sites

  • Study site

    Ahmedabad, 380006

  • Study site

    Ahmedabad, 380008

  • Study site

    Ahmedabad, 380015

  • Study site

    Bangalore, 560054

  • Study site

    Jaipur, 302017

  • Study site

    Jaipur, 302021

  • Study site

    Kalyān, 421301

  • Study site

    Mangalore, 575001

  • Study site

    Mangalore, 575018

  • Study site

    Nashik, 422101

  • Study site

    Pune, 411030

  • Study site

    Vadodara, 390001

Other trials in India

Argentina10 sites

  • Study site

    Buenos Aires, 1425

  • Study site

    Buenos Aires, C1425AHQ

  • Study site

    Ciudad Autonoma Bs As, 1117

  • Study site

    Ciudad Autonoma Bs As, 1405

  • Study site

    Córdoba, 5003

  • Study site

    Córdoba, X5009BIN

  • Study site

    La Plata, 1900

  • Study site

    Mendoza, 5500

  • Study site

    Rosario, S2000QJI

  • Study site

    Santiago del Estero, 4200

Other trials in Argentina

South Korea9 sites

  • Study site

    Busan, 614-735

  • Study site

    Gwangju, 501-757

  • Study site

    Gyeonggi-do, 425-707

  • Study site

    Incheon, 400-711

  • Study site

    Incheon, 405-760

  • Study site

    Jeollabuk-do, 561-712

  • Study site

    Seoul, 110-774

  • Study site

    Seoul, 136-705

  • Study site

    Seoul, 150-713

Other trials in South Korea

Romania8 sites

  • Study site

    Arad, 310022

  • Study site

    Bucharest, 010825

  • Study site

    Bucharest, 041914

  • Study site

    Cluj-Napoca, 400012

  • Study site

    Lasi, 700282

  • Study site

    Oradea, 410154

  • Study site

    Sibiu, 550082

  • Study site

    Targouiste, 130081

Other trials in Romania

France6 sites

  • Study site

    Clermont-Ferrand, 63000

  • Study site

    Dole, 39100

  • Study site

    Élancourt, 78990

  • Study site

    Marseille, 13005

  • Study site

    Strasbourg, 67091

  • Study site

    Toulon, 83000

Other trials in France

Hungary6 sites

  • Study site

    Balassagyarmat, 2660

  • Study site

    Budapest, 1032

  • Study site

    Budapest, 1082

  • Study site

    Budapest, 1135

  • Study site

    Győr, 9024

  • Study site

    Gyula, 5700

Other trials in Hungary

Mexico5 sites

  • Study site

    México, 05300

  • Study site

    Monterrey, 64000

  • Study site

    Monterrey, 64060

  • Study site

    Monterrey, 64710

  • Study site

    San Luis Potosí City, 72818

Other trials in Mexico

Australia4 sites

  • Study site

    Clayton, Victoria, 3168

  • Study site

    Frankston, Victoria, 3199

  • Study site

    Melbourne, Victoria, 3004

  • Study site

    Westmead, New South Wales, 2145

Other trials in Australia

Sweden4 sites

  • Study site

    Malmö, 21135

  • Study site

    Stockholm, 14186

  • Study site

    Stockholm, 18288

  • Study site

    Uppsala, 75185

Other trials in Sweden

United Kingdom4 sites

  • Study site

    Edinburgh, EH10 5HF

  • Study site

    London, SE5-8AF

  • Study site

    London, W12 0HS

  • Study site

    Oxford, OX3 7JX

Other trials in United Kingdom

Colombia3 sites

  • Study site

    Barranquilla

  • Study site

    Bello

  • Study site

    Bogotá

Other trials in Colombia

Finland2 sites

  • Study site

    Helsinki, 00250

  • Study site

    Kuopio, 70100

Other trials in Finland

About this study

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.

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.

Conditions
Schizophrenia
Being tested
Placebo, RO4917838
Medical subject headings
Schizophrenia

What participants receive

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

  • PlaceboDrug

    Oral doses, once a day for 52 weeks

  • RO4917838Drug

    Oral dose level 1, once a day for 52 weeks

  • RO4917838Drug

    Oral dose level 2, once a day for 52 weeks

Study groups in NCT01235520
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: RO4917838
2ExperimentalNot described
Receives: Drug: RO4917838
3Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS)

    Measured: Change from baseline to Week 12

  2. Safety (incidence of adverse events)

    Measured: Week 12

Secondary outcomes (4)

  1. Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS)

    Measured: Change from baseline to Week 12

  2. Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale

    Measured: Change from baseline to Week 12

  3. Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale

    Measured: Change from baseline to Week 12

  4. Safety (incidence of adverse events)

    Measured: 60 weeks

Timeline

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

  1. First posted5 Nov 2010 (estimated)
  2. Study startJan 2011
  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
595 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01235520
Sponsor's protocol ID
NN25307
Other IDs
2010-020696-23
Status last verified
Jun 2015
First submitted
22 Oct 2010
Last updated
2 Jun 2015
Results posted
No

Publications

  • 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.

    PubMed 27816567

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 121 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 5 inclusion and 5 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 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in United States, Russia, India, Argentina, South Korea 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?

Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS) (time frame: Change from baseline to Week 12). 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 NCT01235520, which also lists 1 linked publication.

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 2 Jun 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in