SchizophreniaPhase 3NCT01235585
A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25306)
A Phase 3 study testing bitopertin [RO4917838] in people with Schizophrenia, run by Hoffmann-La Roche at 120 sites in 14 countries.
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]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 597 participants
- Where
- 120 sitesin 14 countries
- Study dates
- Dec 2010to Sep 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
120 sites in 14 countries.
120 sites in 14 countries
United States25 sites
Study site
Allentown, Pennsylvania, 18104
Study site
Atlanta, Georgia, 30328
Study site
Bothell, Washington, 98011
Study site
Carson, California, 90746
Study site
Cedarhurst, New York, 11516
Study site
Chicago, Illinois, 60612
Study site
Garden Grove, California, 92845
Study site
Hartford, Connecticut, 06106
Study site
Hoffman Estates, Illinois, 60169
Study site
Jamaica, New York, 11418
Study site
Joliet, Illinois, 60435
Study site
Lake Charles, Louisiana, 70601
Study site
Long Beach, California, 90813
Study site
Long Beach, California, 90822
Study site
Norristown, Pennsylvania, 19403
Study site
North Miami, Florida, 33161
Study site
Norwalk, Connecticut, 06851
Study site
Oceanside, California, 92056
Study site
Omahac, Nebraska, 68131
Study site
Philadelphia, Pennsylvania, 19139
Study site
Rochester, New York, 14623
Study site
San Diego, California, 92121
Study site
San Diego, California, 92123
Study site
St Louis, Missouri, 63128
Study site
St Louis, Missouri, 63141
Brazil10 sites
Study site
Belo Horizonte, Minas Gerais, 30150-270
Study site
Curitiba, Paraná, 80240-280
Study site
Goiânia, Goiás, 74093-040
Study site
Itapira, São Paulo, 13970-905
Study site
Pelotas, Rio Grande do Sul, 96030-002
Study site
Porto Alegre, Rio Grande do Sul, 90035-003
Study site
Rio de Janeiro, Rio de Janeiro, 22270-060
Study site
Salvador, Estado de Bahia, 40301-500
Study site
São Paulo, São Paulo, 04044-000
Study site
São Paulo, São Paulo, 05403-010
Canada9 sites
Study site
Burlington, Ontario, L7R 4E2
Study site
Calgary, Alberta, T2N 4Z6
Study site
Halifax, Nova Scotia, B3H 2E2
Study site
Hamilton, Ontario, L8N 3K7
Study site
Medicine Hat, Alberta, T1B 4E7
Study site
Mississauga, Ontario, L5M 4N4
Study site
Montreal, Quebec, H1N 3M5
Study site
Montreal, Quebec, H3A 1A1
Study site
Vancouver, British Columbia, V5Z 3P1
Poland9 sites
Study site
Choroszcz, 16-070
Study site
Kielce, 25-103
Study site
Lublin, 20-045
Study site
Lublin, 20-080
Study site
Lublin, 20-582
Study site
Piekary Śląskie, 41-940
Study site
Skorzewo, 60-185
Study site
Tuszyn, 95-080
Study site
Warsaw, 02-957
Turkey (Türkiye)9 sites
Study site
Ankara, 06100
Study site
Diyarbakır, 21280
Study site
Gaziantep, 27310
Study site
Istanbul, 34000
Study site
Istanbul, 34390
Study site
Istanbul, 34736
Study site
Kocaeli, 41380
Study site
Manisa, 45030
Study site
Mersin, 33169
Ukraine9 sites
Study site
Dnipropetrovsk, 49005
Study site
Donetsk, 83008
Study site
Glevakha Kyviv Region, 08631
Study site
Kharkiv, 61068
Study site
Kyiv, 02660
Study site
Kyiv, 04080
Study site
Lviv, 79021
Study site
Odesa, 65117
Study site
Vinnytsia, 21005
Germany8 sites
Study site
Berlin, 10117
Study site
Bochum, 44805
Study site
Cologne, 50937
Study site
Freiburg im Breisgau, 79104
Study site
Hamburg, 20246
Study site
München, 80336
Study site
München, 81675
Study site
Nuremberg, 90402
Spain8 sites
Study site
Barcelona, Barcelona, 08036
Study site
Barcelona, Barcelona, 08304
Study site
Barcelona, Barcelona, 08830
Study site
Madrid, Madrid, 28009
Study site
Madrid, Madrid, 28040
Study site
Oviedo, Principality of Asturias, 33011
Study site
Salamanca, Salamanca, 37007
Study site
Zamora, Zamora, 49021
Chile7 sites
Study site
Santiago, 7500710
Study site
Santiago, 7501126
Study site
Santiago, 8050000
Study site
Santiago, 8320000
Study site
Santiago, 8900000
Study site
Santiago
Study site
Valdivia, 5090000
Lithuania7 sites
Study site
Kaunas, 44279
Study site
Kaunas, 48259
Study site
Kaunas, 50009
Study site
Kaunas, 53136
Study site
Šilutė, 99142
Study site
Vilnius, 07156
Study site
Vilnius, 10204
Taiwan7 sites
Study site
Hualian Town, 970
Study site
Kaohsiung City, 80276
Study site
Taichung, 407
Study site
Tainan, 704
Study site
Tainan County, 717
Study site
Taipei, 00112
Study site
Taipei, 110
Slovakia6 sites
Study site
Bojnice, 972 01
Study site
Bratislava, 820 07
Study site
Bratislava, 851 01
Study site
Rimavská Sobota, 97912
Study site
Svidník, 089 01
Study site
Trnava, 917 75
Latvia3 sites
Study site
Daugovpils, LV-5417
Study site
Jelgava, LV-3008
Study site
Liepāja, LV 3401
Netherlands3 sites
Study site
Assen, 9400 RA
Study site
Groningen, 9700 AB
Study site
Groningen, 9713 GZ
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]
- 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]Drug
Oral dose level 1, once a day for 52 weeks
bitopertin [RO4917838]Drug
Oral dose level 2, once a day for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bitopertin oral dose level 1 | Experimental | Not described Receives: Drug: bitopertin [RO4917838] |
| Bitopertin oral dose level 2 | Experimental | Not described Receives: Drug: bitopertin [RO4917838] |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS)
Measured: Change from baseline to Week 12
Safety (incidence of adverse events)
Measured: Week 12
Secondary outcomes (4)
Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS)
Measured: Change from baseline to Week 12
Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale
Measured: Change from baseline to Week 12
Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale
Measured: Change from baseline to Week 12
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.
- First posted5 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235585
- Sponsor's protocol ID
- WN25306
- Other IDs
- 2010-020616-11
- 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01235585
- Acronym / sponsor ID
- WN25306
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 5 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bitopertin oral dose level 1 | Experimental | Drug: bitopertin [RO4917838] |
| Bitopertin oral dose level 2 | Experimental | Drug: bitopertin [RO4917838] |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboOral doses, once a day for 52 weeks | Drug | Placebo |
| bitopertin [RO4917838]Oral dose level 1, once a day for 52 weeks | Drug | Bitopertin oral dose level 1 |
| bitopertin [RO4917838]Oral dose level 2, once a day for 52 weeks | Drug | Bitopertin oral dose level 2 |
Primary outcome
Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS)
Time frame: Change from baseline to Week 12
Safety (incidence of adverse events)
Time frame: Week 12
4 secondary outcomes
Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS)
Time frame: Change from baseline to Week 12
Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale
Time frame: Change from baseline to Week 12
Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale
Time frame: Change from baseline to Week 12
Safety (incidence of adverse events)
Time frame: 60 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 27816567Bugarski-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
120 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bitopertin [RO4917838] in people with Schizophrenia, run by Hoffmann-La Roche at 120 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 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 120 sites in United States, Brazil, Canada, Poland, Turkey (Türkiye) 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 NCT01235585, 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.