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AzTrials

SchizophreniaPhase 3NCT01235559

A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)

A Phase 3 study testing bitopertin [RO4917838] level 1 and bitopertin [RO4917838] level 2 in people with Schizophrenia, run by Hoffmann-La Roche at 90 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 randomized, multi-center double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) 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?
bitopertin [RO4917838] level 1 and bitopertin [RO4917838] level 2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
604 participants
Where
90 sitesin 7 countries
Study dates
Dec 2010to Mar 2015
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

90 sites in 7 countries.

90 sites in 7 countries

Japan26 sites

  • Study site

    Chiba, 272-8516

  • Study site

    Funabashi-shi, 273-8540

  • Study site

    Gunma, 370-2455

  • Study site

    Hiroshima, 733-0864

  • Study site

    Hokkaido, 060-8648

  • Study site

    Kanzaki-gun, 842-0192

  • Study site

    Kita-ku, 114-0024

  • Study site

    Kitakyushu-shi, 807-8556

  • Study site

    Kochi, 780-8535

  • Study site

    Koshi-shi, 861-1116

  • Study site

    Kumamoto, 861-8002

  • Study site

    Kurayoshi-shi, 682-0023

  • Study site

    Nagoya, 463-0802

  • Study site

    Omuta-shi, 836-0004

  • Study site

    Sakaishi, 590-0018

  • Study site

    Sapporo, 004-0841

  • Study site

    Sapporo, 006-0816

  • Study site

    Sendai, 983-0836

  • Study site

    Shirakawa-shi, 961-0021

  • Study site

    Tokyo, 162-8666

  • Study site

    Tokyo, 187-8551

  • Study site

    Toyama, 939-8073

  • Study site

    Toyoake-shi, 470-1192

  • Study site

    Yokohama, 223-0062

  • Study site

    Yokohama, 233-0006

  • Study site

    Yokohama, 246-0026

Other trials in Japan

United States22 sites

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Austin, Texas, 78754

  • Study site

    Buffalo, New York, 14215

  • Study site

    Costa Mesa, California, 92626

  • Study site

    Durham, North Carolina, 27705

  • Study site

    Escondido, California, 92025

  • Study site

    Flowood, Mississippi, 39232

  • Study site

    Granada Hills, California, 91344

  • Study site

    Indianapolis, Indiana, 46222

  • Study site

    Irving, Texas, 75062

  • Study site

    La Jolla, California, 92093

  • Study site

    Las Vegas, Nevada, 89102

  • Study site

    Lauderhill, Florida, 33319

  • Study site

    New York, New York, 10032

  • Study site

    Oceanside, California, 92056

  • Study site

    Orange City, Florida, 3273

  • Study site

    Plantation, Florida, 33317

  • Study site

    Rochester, New York, 14618

  • Study site

    Salt Lake City, Utah, 84106

  • Study site

    San Diego, California, 92103

  • Study site

    Scranton, Pennsylvania, 18503

  • Study site

    Torrance, California, 90502

Other trials in United States

China16 sites

  • Study site

    Baoding, 071000

  • Study site

    Beijing, 071000

  • Study site

    Beijing, 100083

  • Study site

    Beijing, 100088

  • Study site

    Changsha, 410011

  • Study site

    Chengdu, 610041

  • Study site

    GuangzhouGuangdong, 510370

  • Study site

    Hangzhou, 310003

  • Study site

    Kunming, 650032

  • Study site

    Nanjing, 210029

  • Study site

    Shanghai, 200030

  • Study site

    Shanghai, 200065

  • Study site

    Wuhan, 430060

  • Study site

    Wuxi, 214151

  • Study site

    Xi'an, 710032

  • Study site

    Xi'an, 710061

Other trials in China

Italy9 sites

  • Study site

    Bari, Apulia, 70124

  • Study site

    Brescia, Lombardy, 25123

  • Study site

    Milan, Lombardy, 20121

  • Study site

    Milan, Lombardy, 20122

  • Study site

    Naples, Campania, 80131

  • Study site

    Padova, Veneto, 35128

  • Study site

    Pisa, Tuscany, 56124

  • Study site

    Pisa, Tuscany, 56126

  • Study site

    Turin, Piedmont, 10126

Other trials in Italy

Bulgaria8 sites

  • Study site

    Burgas, 8000

  • Study site

    Kazanlak, 6100

  • Study site

    Novi Iskar, 1282

  • Study site

    Pazardzhik, 4400

  • Study site

    Plovdiv, 4002

  • Study site

    Radnevo, 6260

  • Study site

    Rousse, 7003

  • Study site

    Sofia, 1606

Other trials in Bulgaria

Czechia8 sites

  • Study site

    Brno, 602 00

  • Study site

    Liberec, 460 63

  • Study site

    Mělník, 276 01

  • Study site

    Pilsen, 312 00

  • Study site

    Prague, 100 00

  • Study site

    Prague, 160 00

  • Study site

    Praha 8 - Bohnice, 181 03

  • Study site

    Sternberk, 785 01

Other trials in Czechia

Russia1 site

  • Study site

    Saint Petersburg, 190121

Other trials in Russia

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 (bitopertin) 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, bitopertin [RO4917838] level 1, bitopertin [RO4917838] level 2
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

  • bitopertin [RO4917838] level 1Drug

    Oral dose level 1, once a day for 52 weeks

  • bitopertin [RO4917838] level 2Drug

    Oral dose level 2, once a day for 52 weeks

Study groups in NCT01235559
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
bitopertin [RO4917838] 1ExperimentalNot described
Receives: Drug: bitopertin [RO4917838] level 1
bitopertin [RO4917838] 2ExperimentalNot described
Receives: Drug: bitopertin [RO4917838] level 2

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 startDec 2010
  3. Primary completionMar 2015
  4. Study completionMar 2015

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
604 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01235559
Sponsor's protocol ID
WN25305
Other IDs
2010-020718-26
Status last verified
Nov 2016
First submitted
22 Oct 2010
Last updated
2 Nov 2016
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 bitopertin [RO4917838] level 1 and bitopertin [RO4917838] level 2 in people with Schizophrenia, run by Hoffmann-La Roche at 90 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 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 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in Japan, United States, China, Italy, Bulgaria 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?

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 NCT01235559, 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 Nov 2016.

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