Clinical trial NCT00563706: Study Evaluating Vabicaserin in Subjects With Schizophrenia
Official title: A Randomized, Double-Blind, Placebo-Controlled, Risperidone-Referenced, Parallel-Group, Adaptive-Design Study of the Efficacy, Safety, and Tolerability of Vabicaserin (SCA-136) in Subjects With Acute Exacerbations of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-26
Enrollment: 199
Sex: MALE
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 primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Generally healthy, men and women, aged 18 to 65.
* Hospitalization because of an acute exacerbation of schizophrenia with a diagnosis of schizophrenia established greater than 1 year.
* Ability to remain hospitalized for the duration of the screening period and for 4 weeks of double-blind treatment.

Exclusion Criteria:

* Current Axis I primary psychiatric diagnosis other than schizophrenia (DSM-IV-TR criteria).
* Current diagnosis or history of substance abuse or dependence (DSM-IV-TR criteria), including alcohol (except for nicotine), within 3 months before baseline (day -1).
* Subjects taking high or chronic doses of benzodiazepine at the screening evaluation who, in the investigator's judgment, would be likely to have severe withdrawal symptoms upon discontinuation.

Primary outcomes:
measure: Positive and Negative Symptom Scale (PANSS) Total Score at Baseline
timeFrame: Baseline
measure: Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28
timeFrame: Baseline, Day 28
Secondary outcomes:
measure: Positive and Negative Symptom Scale (PANSS) Positive Subscale Score
timeFrame: Baseline, Day 7, 14, 21, 28
measure: Positive and Negative Symptom Scale (PANSS) Negative Subscale Score
timeFrame: Baseline, Day 7, 14, 21, 28
measure: Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score
timeFrame: Baseline, Day 7, 14, 21, 28
measure: Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score
timeFrame: Baseline, Day 7, 14, 21, 28
measure: Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score
timeFrame: Baseline, Day 7, 14, 21, 28
measure: Clinical Global Impression - Severity (CGI-S) Score
timeFrame: Baseline, Day 7, 14, 21, 28
measure: Clinical Global Impression - Improvement (CGI-I) Score
timeFrame: Day 7, 14, 21, 28
measure: Calgary Depression Scale for Schizophrenia (CDSS) Score
timeFrame: Baseline, Day 7, 14, 21, 28
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Cerritos
country: United States
facility: Pfizer Investigational Site
state: California
city: Escondido
country: United States
facility: Pfizer Investigational Site
state: California
city: Garden Grove
country: United States
facility: Pfizer Investigational Site
state: California
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Aventura
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hoffman Estates
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Lake Charles
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Rockville
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Hamilton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Willingboro
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Cedarhurst
country: United States
facility: Pfizer Investigational Site
state: New York
city: Holliswood
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Butner
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bellaire
country: United States
facility: Pfizer Investigational Site
state: Texas
city: DeSoto
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Portsmouth
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: