Study Evaluating Vabicaserin in Subjects With Schizophrenia

NCT00563706 | Completed Phase 2 Results DMC

• 2 other identifiers: 3153A1-2203B1911032
• Study Type: interventional
• Target: 199
• Locations: 2 countries
• Sites: 33

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Positive and Negative Symptom Scale (PANSS) Total Score at Baseline

  PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.

  Baseline

• Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28

  PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.

  Baseline, Day 28

Secondary Outcomes (8)

• Positive and Negative Symptom Scale (PANSS) Positive Subscale Score

  Baseline, Day 7, 14, 21, 28

• Positive and Negative Symptom Scale (PANSS) Negative Subscale Score

  Baseline, Day 7, 14, 21, 28

• Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score

  Baseline, Day 7, 14, 21, 28

• Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score

  Baseline, Day 7, 14, 21, 28

• Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score

  Baseline, Day 7, 14, 21, 28

Study Arms (3)

1

EXPERIMENTAL

Drug: vabicaserin

2

ACTIVE COMPARATOR

4mg/day

Drug: risperidone

3

PLACEBO COMPARATOR

matching placebo

Other: placebo

Interventions

vabicaserin DRUG

This study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study

1

risperidone DRUG

2

placebo OTHER

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (33)

Pfizer Investigational Site

Little Rock, Arkansas, 72201, United States

Location

Pfizer Investigational Site

Cerritos, California, 90703, United States

Location

Pfizer Investigational Site

Escondido, California, 92025, United States

Location

Pfizer Investigational Site

Garden Grove, California, 92845, United States

Location

Pfizer Investigational Site

Glendale, California, 91206, United States

Location

Pfizer Investigational Site

San Diego, California, 92103, United States

Location

Pfizer Investigational Site

San Diego, California, 92123, United States

Location

Pfizer Investigational Site

Torrance, California, 90502, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20016, United States

Location

Pfizer Investigational Site

Aventura, Florida, 33180, United States

Location

Pfizer Investigational Site

Hollywood, Florida, 33021, United States

Location

Pfizer Investigational Site

Kissimmee, Florida, 34741, United States

Location

Pfizer Investigational Site

Hoffman Estates, Illinois, 60169, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46222, United States

Location

Pfizer Investigational Site

Lake Charles, Louisiana, 70601, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21202, United States

Location

Pfizer Investigational Site

Rockville, Maryland, 20850, United States

Location

Pfizer Investigational Site

Hamilton, New Jersey, 08619, United States

Location

Pfizer Investigational Site

Willingboro, New Jersey, 08046, United States

Location

Pfizer Investigational Site

Cedarhurst, New York, 11516, United States

Location

Pfizer Investigational Site

Holliswood, New York, 11423, United States

Location

Pfizer Investigational Site

New York, New York, 10032, United States

Location

Pfizer Investigational Site

Butner, North Carolina, 27509, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19131, United States

Location

Pfizer Investigational Site

Austin, Texas, 78754, United States

Location

Pfizer Investigational Site

Austin, Texas, 78756, United States

Location

Pfizer Investigational Site

Bellaire, Texas, 77008, United States

Location

Pfizer Investigational Site

DeSoto, Texas, 75115, United States

Location

Pfizer Investigational Site

Houston, Texas, 77008, United States

Location

Pfizer Investigational Site

Arlington, Virginia, 22201, United States

Location

Pfizer Investigational Site

Portsmouth, Virginia, 23707, United States

Location

Pfizer Investigational Site

Kingston, Ontario, K7L 4X3, Canada

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Schizophrenia

Interventions

vabicaserin; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 26, 2007
• Study Start: December 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: March 20, 2014
• Results First Posted: March 20, 2014

Record last verified: 2014-02

Locations

US (32); CA (1)