Study Evaluating Vabicaserin in Subjects With Schizophrenia

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Other: placebo; Drug: risperidone; Drug: vabicaserin

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 4X3
      • Pfizer Investigational Site
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72201
      • Pfizer Investigational Site
  • California
    • Cerritos, California, United States, 90703
      • Pfizer Investigational Site
    • Escondido, California, United States, 92025
      • Pfizer Investigational Site
    • Garden Grove, California, United States, 92845
      • Pfizer Investigational Site
    • Glendale, California, United States, 91206
      • Pfizer Investigational Site
    • San Diego, California, United States, 92103
      • Pfizer Investigational Site
    • San Diego, California, United States, 92123
      • Pfizer Investigational Site
    • Torrance, California, United States, 90502
      • Pfizer Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Pfizer Investigational Site
  • Florida
    • Aventura, Florida, United States, 33180
      • Pfizer Investigational Site
    • Hollywood, Florida, United States, 33021
      • Pfizer Investigational Site
    • Kissimmee, Florida, United States, 34741
      • Pfizer Investigational Site
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Pfizer Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46222
      • Pfizer Investigational Site
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Pfizer Investigational Site
    • Rockville, Maryland, United States, 20850
      • Pfizer Investigational Site
  • New Jersey
    • Hamilton, New Jersey, United States, 08619
      • Pfizer Investigational Site
    • Willingboro, New Jersey, United States, 08046
      • Pfizer Investigational Site
  • New York
    • Cedarhurst, New York, United States, 11516
      • Pfizer Investigational Site
    • Holliswood, New York, United States, 11423
      • Pfizer Investigational Site
    • New York, New York, United States, 10032
      • Pfizer Investigational Site
  • North Carolina
    • Butner, North Carolina, United States, 27509
      • Pfizer Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Pfizer Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19131
      • Pfizer Investigational Site
  • Texas
    • Austin, Texas, United States, 78756
      • Pfizer Investigational Site
    • Austin, Texas, United States, 78754
      • Pfizer Investigational Site
    • Bellaire, Texas, United States, 77008
      • Pfizer Investigational Site
    • DeSoto, Texas, United States, 75115
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77008
      • Pfizer Investigational Site
  • Virginia
    • Arlington, Virginia, United States, 22201
      • Pfizer Investigational Site
    • Portsmouth, Virginia, United States, 23707
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: vabicaserin; 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
Active Comparator: 2; 4mg/day	Drug: risperidone
Placebo Comparator: 3; matching placebo	Other: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and Negative Symptom Scale (PANSS) Positive Subscale Score	PANSS positive subscale assesses positive symptoms associated with schizophrenia. The positive subscale consists of 7 items (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49; higher score indicates greater severity.	Baseline, Day 7, 14, 21, 28
Positive and Negative Symptom Scale (PANSS) Negative Subscale Score	PANSS negative subscale assesses negative symptoms associated with schizophrenia. The negative subscale consists of 7 items (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49; higher score indicates greater severity.	Baseline, Day 7, 14, 21, 28
Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score	General psychopathology subscale assesses general psychopathology symptoms associated with schizophrenia. The general psychopathology subscale consists of 16 items (somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total general psychopathology subscale scores range from 16 to 112; higher score indicates greater severity.	Baseline, Day 7, 14, 21, 28
Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score	Cognition cluster subscale assesses cognitive symptoms associated with schizophrenia. The cognition cluster subscale score is a sum of 5 items from positive, negative and general psychopathology subscales (conceptual disorganization, difficulty in abstract thinking, poor attention, lack of judgment and insight, and preoccupation). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total cognition cluster subscale scores range from 5 to 35; higher score indicates greater severity.	Baseline, Day 7, 14, 21, 28
Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score	Responders were defined as 20 percent (%) responders and 50 % responders. A 20% responder was a participant whose PANSS total score was decreased by at least 20% from baseline to the week of assessment. A 50% responder was a participant whose PANSS total score was decreased by at least 50 % from baseline to the week of assessment. PANSS total score 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 7, 14, 21, 28
Clinical Global Impression - Severity (CGI-S) Score	CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).	Baseline, Day 7, 14, 21, 28
Clinical Global Impression - Improvement (CGI-I) Score	CGI-I: 7-point clinician rated scale to assess global improvement in the participant's clinical state compared to baseline; range: 1 (very much improved) to 7 (very much worse).	Day 7, 14, 21, 28
Calgary Depression Scale for Schizophrenia (CDSS) Score	CDSS: 9-item clinician rated scale, validated for rating the severity of depressive symptoms in participants with schizophrenia. Each item is rated on a 4-point scale ranging from 0 (absent) to 3 (severe). CDSS total score is the sum of each item scores and ranges from 0 to 27; higher score indicates more severity of symptoms.	Baseline, Day 7, 14, 21, 28

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: November 21, 2007
• First Submitted That Met QC Criteria: November 21, 2007
• First Posted (Estimate): November 26, 2007

Study Record Updates

• Last Update Posted (Estimate): March 20, 2014
• Last Update Submitted That Met QC Criteria: February 3, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: 3153A1-2203; B1911032