Clinical trial NCT00265551: Study Evaluating SCA-136 in Subjects With Acute Exacerbations of Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-12-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of schizophrenia
* Ability to remain hospitalized for at least first 4 weeks of study
* Needs hospitalization due to worsening of schizophrenia

Exclusion Criteria:

* Type 1 or 2 diabetes
* Previous use of clozapine
* Serious medical illness other than schizophrenia

Primary outcomes:
measure: Change from baseline to day 42 on the positive subscale of the SCI-PANNS
Secondary outcomes:
measure: Change from baseline to day 42 on:
measure: SCI-PANNS total score
measure: negative symptom sub-scale score of SCI-PANNS
measure: general psychopathology subscale score of SCI-PANNS
measure: response rate based upon SCI-PANNS total score
measure: BPRS score
measure: CGI-S score
measure: CGI-I score
measure: Cognitive assessments scores
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Cerritos
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Paramount
country: United States
state: California
city: Pico Rivera
country: United States
state: California
city: Rosemead
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Middletown
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Fort Lauderdale
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Hoffman Estates
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lake Charles
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Rockville
country: United States
state: Maryland
city: St. Louis
country: United States
state: Missouri
city: Willingboro
country: United States
state: New Jersey
city: Cedarhurst
country: United States
state: New York
city: Holliswood
country: United States
state: New York
city: Chagrin Falls
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Fort Washington
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: DeSoto
country: United States
state: Texas
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.