SchizophreniaPhase 2NCT01234779
A Study of RO4917838 (Bitopertin) in Patients With Acute Exacerbation of Schizophrenia
A Phase 2 study testing bitopertin [RO4917838] and olanzapine in people with Schizophrenia, run by Hoffmann-La Roche at 46 sites in 5 countries.
Trial summary
This randomized, double-blind, placebo- and active-controlled, parallel group study will evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute exacerbation of schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- bitopertin [RO4917838] and olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 301 participants
- Where
- 46 sitesin 5 countries
- Study dates
- Feb 2011to Sep 2012
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, 18-65 years of age
- Diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders DSM IV-TR)
- Acute exacerbation which began within the prior 8 weeks
- Female patients must be surgically sterile or post-menopausal, or agree to use effective contraception for the duration of the study
Who cannot join
- Current psychiatric diagnosis other than schizophrenia
- Alcohol or substance dependence within 3 months or abuse within 1 month (except for nicotine)
- Electro-convulsive therapy (ECT) within the prior 6 months
- Previous treatment with RO4917838 or another GLYT inhibitor
- Current treatment with olanzapine, or previous treatment with intolerability or lack of response
- Treatment with long-acting injectable antipsychotic within 2 dosing intervals
Show all 9Show fewer
- Treatment with > 2 antipsychotics within 3 months
- History of neuroleptic malignant syndrome
- Have treatment-resistant schizophrenia as judged by treating physician or have failed two trials according to criteria in protocol
Trial locations and contacts
46 sites in 5 countries.
46 sites in 5 countries
United States19 sites
Study site
Atlanta, Georgia, 30308
Study site
Austin, Texas, 78754
Study site
Cerritos, California, 90703
Study site
Charlesston, South Carolina, 29405
Study site
Cincinnati, Ohio, 45219
Study site
Flowood, Mississippi, 39232
Study site
Holliswood, New York, 11423
Study site
Irving, Texas, 75062
Study site
Lake Charles, Louisiana, 70601
Study site
Lauderhill, Florida, 33021
Study site
Little Rock, Arkansas, 72201
Study site
New York, New York, 11004
Study site
North Miami, Florida, 33161
Study site
Oceanside, California, 92056
Study site
Philadelphia, Pennsylvania, 19139
Study site
Pico Rivera, California, 90660
Study site
San Diego, California, 92121
Study site
St Louis, Missouri, 63141
Study site
Willingboro, New Jersey, 08046
Russia9 sites
Study site
Gatchina, 188357
Study site
Moscow, 117152
Study site
Petrozavodsk, 186131
Study site
Saint Petersburg, 190005
Study site
Saint Petersburg, 192019
Study site
Saint Petersburg, 193167
Study site
Saint Petersburg, 194044
Study site
Saint Petersburg, 197341
Study site
Talagi, 163530
Romania7 sites
Study site
Arad, 310022
Study site
Bucharest, 010825
Study site
Bucharest, 041902
Study site
Bucharest, 041914
Study site
Foscani, 620165
Study site
Oradea, 410154
Study site
Targoviste, 130086
Ukraine7 sites
Study site
Dnipropetrovsk, 49027
Study site
Donetsk, 83008
Study site
Kherson,Vil. Stepanivka, 73488
Study site
Kyiv, 02660
Study site
Kyiv, 04080
Study site
Poltava, 36006
Study site
Vinnytsia, 21005
Slovakia4 sites
Study site
Bojnice, 972 01
Study site
Bratislava, 826 06
Study site
Liptovský Mikuláš, 3123
Study site
Michalovce, 071 01
About this study
Official title: A Phase II, Multi-center, Randomized, 4-week, Double-blind, Parallel Group, Placebo and Active-controlled Trial of the Safety and Efficacy of RO4917838 vs. Placebo in Patients With an Acute Exacerbation of Schizophrenia
This randomized, double-blind, placebo- and active-controlled, parallel group study will evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute exacerbation of schizophrenia. Patients will be randomized to receive either RO4917838 10 mg or RO4917838 30 mg or olanzapine 15 mg or placebo orally daily for 4 weeks as inpatients, with a 4-week follow-up period.
- Conditions
- Schizophrenia
- Being tested
- bitopertin [RO4917838], olanzapine, placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bitopertin [RO4917838]Drug
10 mg orally daily, 4 weeks
bitopertin [RO4917838]Drug
30 mg orally daily, 4 weeks
olanzapineDrug
15 mg orally daily, 4 weeks
placeboDrug
orally daily, 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: bitopertin [RO4917838] |
| B | Experimental | Not described Receives: Drug: bitopertin [RO4917838] |
| C | Active comparator | Not described Receives: Drug: olanzapine |
| D | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive and Negative Syndrome Scale (PANSS) total score
Measured: from baseline to Day 28
Safety: Incidence adverse events
Measured: 8 weeks
Secondary outcomes (6)
Clinical response, defined as at least 30% or 50% improvement from baseline PANSS total score
Measured: from baseline to Day 28
Change in symptomatology as measured by the PANSS factor and subscale scores
Measured: from baseline to Day 28
Global improvement as measured by the Clinical Global Impressions-Severity (CGI-S) scale
Measured: from baseline to Day 28
Global improvement as measured by the Clinical Global Impressions-Change (CGI-C) rating scale
Measured: from baseline to Day 28
Observable behavioural change as determined by the Nurses' Observation Scale For Inpatient Evaluation (NOSIE)
Measured: from baseline to Day 28
Time to readiness for discharge from inpatient unit as assessed by the Readiness For Hospital Discharge Questionnaire (RDQ)
Measured: from baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startFeb 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 301 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
- NCT01234779
- Sponsor's protocol ID
- WN25333
- Other IDs
- 2010-021984-33
- Status last verified
- Nov 2016
- First submitted
- 3 Nov 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
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
- A Phase II, Multi-center, Randomized, 4-week, Double-blind, Parallel Group, Placebo and Active-controlled Trial of the Safety and Efficacy of RO4917838 vs. Placebo in Patients With an Acute Exacerbation of Schizophrenia
- ClinicalTrials.gov ID
- NCT01234779
- Acronym / sponsor ID
- WN25333
- Conditions
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 4 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, double-blind, placebo- and active-controlled, parallel group study will evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute exacerbation of schizophrenia. Patients will be randomized to receive either RO4917838 10 mg or RO4917838 30 mg or olanzapine 15 mg or placebo orally daily for 4 weeks as inpatients, with a 4-week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: bitopertin [RO4917838] |
| B | Experimental | Drug: bitopertin [RO4917838] |
| C | Active comparator | Drug: olanzapine |
| D | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients, 18-65 years of age
- Diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders DSM IV-TR)
- Acute exacerbation which began within the prior 8 weeks
- Female patients must be surgically sterile or post-menopausal, or agree to use effective contraception for the duration of the study
Key exclusion criteria (9 listed)
- Current psychiatric diagnosis other than schizophrenia
- Alcohol or substance dependence within 3 months or abuse within 1 month (except for nicotine)
- Electro-convulsive therapy (ECT) within the prior 6 months
- Previous treatment with RO4917838 or another GLYT inhibitor
- Current treatment with olanzapine, or previous treatment with intolerability or lack of response
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 |
|---|---|---|
| bitopertin [RO4917838]10 mg orally daily, 4 weeks | Drug | A |
| bitopertin [RO4917838]30 mg orally daily, 4 weeks | Drug | B |
| olanzapine15 mg orally daily, 4 weeks | Drug | C |
| placeboorally daily, 4 weeks | Drug | D |
Primary outcome
Change in Positive and Negative Syndrome Scale (PANSS) total score
Time frame: from baseline to Day 28
Safety: Incidence adverse events
Time frame: 8 weeks
6 secondary outcomes
Clinical response, defined as at least 30% or 50% improvement from baseline PANSS total score
Time frame: from baseline to Day 28
Change in symptomatology as measured by the PANSS factor and subscale scores
Time frame: from baseline to Day 28
Global improvement as measured by the Clinical Global Impressions-Severity (CGI-S) scale
Time frame: from baseline to Day 28
Global improvement as measured by the Clinical Global Impressions-Change (CGI-C) rating scale
Time frame: from baseline to Day 28
Observable behavioural change as determined by the Nurses' Observation Scale For Inpatient Evaluation (NOSIE)
Time frame: from baseline to Day 28
Time to readiness for discharge from inpatient unit as assessed by the Readiness For Hospital Discharge Questionnaire (RDQ)
Time frame: from baseline to Day 28
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.
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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
46 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bitopertin [RO4917838] and olanzapine in people with Schizophrenia, run by Hoffmann-La Roche at 46 sites in 5 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 4 inclusion and 9 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 46 sites in United States, Russia, Romania, Ukraine, Slovakia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 in Positive and Negative Syndrome Scale (PANSS) total score (time frame: from baseline to Day 28). 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?
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.