SchizophreniaPhase 2NCT00265551
Study Evaluating SCA-136 in Subjects With Acute Exacerbations of Schizophrenia
A Phase 2 study testing SCA-136 (200 mg), SCA-136 (400 mg) and olanzapine (15 mg) in people with Schizophrenia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 35 sites in United States.
Trial summary
The purpose of this study is to determine whether a low dose and a high dose of the study drug SCA-136 are effective and safe in the treatment of schizophrenia requiring hospitalization. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SCA-136 (200 mg), SCA-136 (400 mg) and olanzapine (15 mg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 35 sitesUnited States
- Study dates
- Jan 2006to Jan 2007
- 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
- Clinical diagnosis of schizophrenia
- Ability to remain hospitalized for at least first 4 weeks of study
- Needs hospitalization due to worsening of schizophrenia
Who cannot join
- Type 1 or 2 diabetes
- Previous use of clozapine
- Serious medical illness other than schizophrenia
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Study site
Austin, Texas, 78729
Study site
Austin, Texas, 78756
Study site
Baltimore, Maryland, 21202
Study site
Cedarhurst, New York, 11516
Study site
Cerritos, California, 90703
Study site
Chagrin Falls, Ohio, 44022
Study site
Cincinnati, Ohio, 45220
Study site
Cincinnati, Ohio, 45267
Study site
Costa Mesa, California, 92627
Study site
DeSoto, Texas, 75115
Study site
Fort Lauderdale, Florida, 33301
Study site
Fort Washington, Pennsylvania, 19034
Study site
Hoffman Estates, Illinois, 60194
Study site
Holliswood, New York, 11423
Study site
Indianapolis, Indiana, 46222
Study site
Kissimmee, Florida, 34741
Study site
La Mesa, California, 91942
Study site
Lake Charles, Louisiana, 70601
Study site
Little Rock, Arkansas, 72201
Study site
Memphis, Tennessee, 38117
Study site
Middletown, Connecticut, 06457
Study site
North Miami, Florida, 33161
Study site
Oceanside, California, 92056
Study site
Oklahoma City, Oklahoma, 73103
Study site
Paramount, California, 90723
Study site
Pico Rivera, California, 90660
Study site
Rockville, Maryland, 20850
Study site
Rosemead, California, 91770
Study site
San Diego, California, 92103
Study site
San Diego, California, 92123
Study site
St Louis, Missouri, 63118
Study site
Tacoma, Washington, 98493
Study site
Torrance, California, 90502
Study site
Washington D.C., District of Columbia, 20016
Study site
Willingboro, New Jersey, 08046
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Olanzapine-Referenced, Parallel Group Safety, Efficacy, and Tolerability Study of SCA-136 in Subjects With Acute Exacerbations of Schizophrenia
The purpose of this study is to determine whether a low dose and a high dose of the study drug SCA-136 are effective and safe in the treatment of schizophrenia requiring hospitalization.
- Conditions
- Schizophrenia
- Being tested
- SCA-136 (200 mg), SCA-136 (400 mg), olanzapine (15 mg), placebo
- Keywords
- Schizophrenia
- 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 (200 mg)Drug
SCA-136 (400 mg)Drug
olanzapine (15 mg)Drug
placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to day 42 on the positive subscale of the SCI-PANNS
Secondary outcomes (9)
Change from baseline to day 42 on:
SCI-PANNS total score
negative symptom sub-scale score of SCI-PANNS
general psychopathology subscale score of SCI-PANNS
response rate based upon SCI-PANNS total score
BPRS score
CGI-S score
CGI-I score
Cognitive assessments scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2005 (estimated)
- Study startJan 2006
- Study completionJan 2007
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.
- 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
- 300 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265551
- Sponsor's protocol ID
- 3153A1-202
- Status last verified
- Dec 2007
- First submitted
- 12 Dec 2005
- Last updated
- 10 Dec 2007
- Results posted
- No
Publications
Shen JH, Zhao Y, Rosenzweig-Lipson S, Popp D, Williams JB, Giller E, Detke MJ, Kane JM. A 6-week randomized, double-blind, placebo-controlled, comparator referenced trial of vabicaserin in acute schizophrenia. J Psychiatr Res. 2014 Jun;53:14-22. doi: 10.1016/j.jpsychires.2014.02.012. Epub 2014 Feb 24.
PubMed 24613032
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Olanzapine-Referenced, Parallel Group Safety, Efficacy, and Tolerability Study of SCA-136 in Subjects With Acute Exacerbations of Schizophrenia
- ClinicalTrials.gov ID
- NCT00265551
- Acronym / sponsor ID
- 3153A1-202
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Jan 2007 (actual)
- First posted
- 14 Dec 2005 (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.
The purpose of this study is to determine whether a low dose and a high dose of the study drug SCA-136 are effective and safe in the treatment of schizophrenia requiring hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of schizophrenia
- Ability to remain hospitalized for at least first 4 weeks of study
- Needs hospitalization due to worsening of schizophrenia
Key exclusion criteria (3 listed)
- Type 1 or 2 diabetes
- Previous use of clozapine
- Serious medical illness other than schizophrenia
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 (200 mg) | Drug | – |
| SCA-136 (400 mg) | Drug | – |
| olanzapine (15 mg) | Drug | – |
| placebo | Drug | – |
Primary outcome
Change from baseline to day 42 on the positive subscale of the SCI-PANNS
9 secondary outcomes
Change from baseline to day 42 on:
SCI-PANNS total score
negative symptom sub-scale score of SCI-PANNS
general psychopathology subscale score of SCI-PANNS
response rate based upon SCI-PANNS total score
BPRS score
CGI-S score
CGI-I score
Cognitive assessments scores
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 10 Dec 2007.
- Derived from this study: PubMed 24613032Shen JH, Zhao Y, Rosenzweig-Lipson S, Popp D, Williams JB, Giller E, Detke MJ, Kane JM. A 6-week randomized, double-blind, placebo-controlled, comparator referenced trial of vabicaserin in acute schizophrenia. J Psychiatr Res. 2014 Jun;53:14-22. doi: 10.1016/j.jpsychires.2014.02.012. Epub 2014 Feb 24.
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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
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCA-136 (200 mg), SCA-136 (400 mg) and olanzapine (15 mg) in people with Schizophrenia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 35 sites in United States.
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: finished, as of the sponsor's last update on 10 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. 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. 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 from baseline to day 42 on the positive subscale of the SCI-PANNS. 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 NCT00265551, 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 10 Dec 2007.