Study Evaluating SCA-136 in Subjects With Acute Exacerbations of Schizophrenia
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
1 other identifier
interventional
300
1 country
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 schizophrenia
Started Jan 2006
Shorter than P25 for phase_2 schizophrenia
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2005
CompletedFirst Posted
Study publicly available on registry
December 14, 2005
CompletedStudy Start
First participant enrolled
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedDecember 10, 2007
December 1, 2007
December 12, 2005
December 7, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
- +4 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of schizophrenia
- Ability to remain hospitalized for at least first 4 weeks of study
- Needs hospitalization due to worsening of schizophrenia
You may not qualify if:
- Type 1 or 2 diabetes
- Previous use of clozapine
- Serious medical illness other than schizophrenia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Unknown Facility
Little Rock, Arkansas, 72201, United States
Unknown Facility
Cerritos, California, 90703, United States
Unknown Facility
Costa Mesa, California, 92627, United States
Unknown Facility
La Mesa, California, 91942, United States
Unknown Facility
Oceanside, California, 92056, United States
Unknown Facility
Paramount, California, 90723, United States
Unknown Facility
Pico Rivera, California, 90660, United States
Unknown Facility
Rosemead, California, 91770, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Torrance, California, 90502, United States
Unknown Facility
Middletown, Connecticut, 06457, United States
Unknown Facility
Washington D.C., District of Columbia, 20016, United States
Unknown Facility
Fort Lauderdale, Florida, 33301, United States
Unknown Facility
Kissimmee, Florida, 34741, United States
Unknown Facility
North Miami, Florida, 33161, United States
Unknown Facility
Hoffman Estates, Illinois, 60194, United States
Unknown Facility
Indianapolis, Indiana, 46222, United States
Unknown Facility
Lake Charles, Louisiana, 70601, United States
Unknown Facility
Baltimore, Maryland, 21202, United States
Unknown Facility
Rockville, Maryland, 20850, United States
Unknown Facility
St Louis, Missouri, 63118, United States
Unknown Facility
Willingboro, New Jersey, 08046, United States
Unknown Facility
Cedarhurst, New York, 11516, United States
Unknown Facility
Holliswood, New York, 11423, United States
Unknown Facility
Chagrin Falls, Ohio, 44022, United States
Unknown Facility
Cincinnati, Ohio, 45220, United States
Unknown Facility
Cincinnati, Ohio, 45267, United States
Unknown Facility
Oklahoma City, Oklahoma, 73103, United States
Unknown Facility
Fort Washington, Pennsylvania, 19034, United States
Unknown Facility
Memphis, Tennessee, 38117, United States
Unknown Facility
Austin, Texas, 78729, United States
Unknown Facility
Austin, Texas, 78756, United States
Unknown Facility
DeSoto, Texas, 75115, United States
Unknown Facility
Tacoma, Washington, 98493, United States
Related Publications (1)
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.
PMID: 24613032DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 12, 2005
First Posted
December 14, 2005
Study Start
January 1, 2006
Study Completion
January 1, 2007
Last Updated
December 10, 2007
Record last verified: 2007-12