SchizophreniaPhase 2NCT00768612
Study Evaluating Safety and Tolerability of Vabicaserin in Patients With Sudden Worsening of Schizophrenia
A Phase 2 study testing SCA-136 50mg/day, SCA-136 150 mg/day and SCA-136 300mg/day in people with Schizophrenia, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
This study will evaluate the clinical safety and tolerability of vabicaserin in Japanese subjects that have a sudden worsening of their symptoms of schizophrenia. The study will also assess the efficacy of vabicaserin and compare it to risperidone. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SCA-136 50mg/day, SCA-136 150 mg/day and SCA-136 300mg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Jul 2009
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects between >=20 and =<65 years of age
- Current diagnosis and DSM-IV-TR diagnosis of schizophrenia type (295.10, 295.30 and 295.90)
- Total PANSS score >=70 and =< 120
Who cannot join
- Subjects who are hospitalized against their will
- Current Axis I primary psychiatric diagnosis other than schizophrenia
- A score of 3 on CDSS question 8 which pertains to suicide
About this study
Official title: A Randomized, Double-Blind, Risperidone-Reference, Parallel-Group, Safety, and Tolerability Study of Vabicaserin (SCA-136) in Japanese Subjects With Acute Exacerbation of Schizophrenia
This study will evaluate the clinical safety and tolerability of vabicaserin in Japanese subjects that have a sudden worsening of their symptoms of schizophrenia. The study will also assess the efficacy of vabicaserin and compare it to risperidone.
- Conditions
- Schizophrenia
- Being tested
- SCA-136 50mg/day, SCA-136 150 mg/day, SCA-136 300mg/day, Risperidone 4mg/day
- Keywords
- Acute, Schizophrenia, Phase2a, Vabicaserin
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCA-136 50mg/dayDrug
SCA-136 150 mg/dayDrug
SCA-136 300mg/dayDrug
Risperidone 4mg/dayDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lowest dose Receives: Drug: SCA-136 50mg/day |
| 2 | Experimental | Middle dose Receives: Drug: SCA-136 150 mg/day |
| 3 | Experimental | Highest dose Receives: Drug: SCA-136 300mg/day |
| 4 | Active comparator | Positive Control Receives: Drug: Risperidone 4mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale PANSS
Measured: 6 week
Secondary outcomes (1)
Calgary Depression Scale for Schizophrenia CDSS
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
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.
- 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768612
- Sponsor's protocol ID
- 3153B1-2208
- Status last verified
- Jan 2013
- First submitted
- 7 Oct 2008
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Risperidone-Reference, Parallel-Group, Safety, and Tolerability Study of Vabicaserin (SCA-136) in Japanese Subjects With Acute Exacerbation of Schizophrenia
- ClinicalTrials.gov ID
- NCT00768612
- Acronym / sponsor ID
- 3153B1-2208
- Conditions
- Schizophrenia
- Keywords
- Acute, Schizophrenia, Phase2a, Vabicaserin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 8 Oct 2008 (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 study will evaluate the clinical safety and tolerability of vabicaserin in Japanese subjects that have a sudden worsening of their symptoms of schizophrenia. The study will also assess the efficacy of vabicaserin and compare it to risperidone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SCA-136 50mg/dayLowest dose |
| 2 | Experimental | Drug: SCA-136 150 mg/dayMiddle dose |
| 3 | Experimental | Drug: SCA-136 300mg/dayHighest dose |
| 4 | Active comparator | Drug: Risperidone 4mg/dayPositive Control |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects between >=20 and =<65 years of age
- Current diagnosis and DSM-IV-TR diagnosis of schizophrenia type (295.10, 295.30 and 295.90)
- Total PANSS score >=70 and =< 120
Key exclusion criteria (3 listed)
- Subjects who are hospitalized against their will
- Current Axis I primary psychiatric diagnosis other than schizophrenia
- A score of 3 on CDSS question 8 which pertains to suicide
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 |
|---|---|---|
| SCA-136 50mg/day | Drug | 1 |
| SCA-136 150 mg/day | Drug | 2 |
| SCA-136 300mg/day | Drug | 3 |
| Risperidone 4mg/day | Drug | 4 |
Primary outcome
Positive and Negative Syndrome Scale PANSS
Time frame: 6 week
1 secondary outcome
Calgary Depression Scale for Schizophrenia CDSS
Time frame: 6 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCA-136 50mg/day, SCA-136 150 mg/day and SCA-136 300mg/day in people with Schizophrenia, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 3 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: withdrawn, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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 and Negative Syndrome Scale PANSS (time frame: 6 week). 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 29 Jan 2013.