Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol and Risperidone
A Randomized, Double Blind, Multi-Center Study to Assess the Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol or Risperidone to Schizophrenic Subjects
1 other identifier
interventional
400
2 countries
17
Brief Summary
The primary purpose of this study is to determine whether a combination of ACP-103 (the study medication) with either haloperidol or risperidone will show antipsychotic efficacy and that it is safe and well tolerated. Further purposes of this study are to determine whether ACP-103, in combination with either haloperidol or risperidone, will enhance their antipsychotic effectiveness, demonstrate effectiveness against the negative symptoms, improve motoric tolerability, and is safe and well tolerated. This is a seven-week study (one week screening and six weeks of study medication) where a total of 400 patients who meet entrance criteria will randomly be assigned to receive one of five groups of study treatments of either low dose haloperidol plus ACP-103, low dose haloperidol plus placebo (a substance similar to a sugar pill), low dose risperidone plus ACP-103, low dose risperidone plus placebo, or high dose risperidone plus placebo. The study will begin with with a three to seven day drug-free period followed by six weeks of a stable daily dosage of study medication. Study subjects will be treated as hospital in-patients during screening and for the first 14 days of the study. Study subjects will be closely monitored throughout the study.
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 Aug 2005
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 3, 2006
CompletedFirst Posted
Study publicly available on registry
August 7, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedMarch 22, 2007
March 1, 2007
August 3, 2006
March 20, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total score on the Positive and Negative Symptom Scale (PANSS).
Secondary Outcomes (1)
Clinical Global Impression-Severity (CGI-S), Simpson Angus Scale (SAS), Barnes Akathisia Scale (BAS), Calgary Depression Scale for Schizophrenia (CDSS)
Interventions
Eligibility Criteria
You may qualify if:
- male or female subjects ages 18-65 diagnosed with schizophrenia
- experiencing an acute exacerbation of psychosis
- has had prior response to antipsychotic therapy within the previous 3 years
- female subjects must be of non-childbearing potential or must comply with double-barrier protection methods against conception
- ability of subject or caregiver or legally authorized representative to provide informed consent
- subjects must be hospitalized at screening and must be willing to remain in the hospital at least 14 days after baseline and must comply with all study events through completion of the study
You may not qualify if:
- inability of the subject or caregiver or legally authorized representative to provide consent
- any female subject who is pregnant or breast feeding
- any subject with concurrent mental illness or disability
- any subject considered to be a danger to themselves or others
- recent use of certain antipsychotics or other medications that might interfere with this study's medication
- abnormal clinical laboratory values
- presence, or recent history, of serious medical conditions or drug abuse
- likely allergy or sensitivity to ACP-103, haloperidol, or risperidone, based on known allergies to drugs of the same class
- any subject who has participated in a prior clinical trial of ACP-103
- any subject judged by the Principal Investigator to be inappropriate for the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Cerritos, California, 90703, United States
Unknown Facility
Garden Grove, California, 92845, United States
Unknown Facility
Glendale, California, 91206, United States
Unknown Facility
Paramount, California, 90723, United States
Unknown Facility
Pico Rivera, California, 90660, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
San Diego, California, 92126, United States
Unknown Facility
Washington D.C., District of Columbia, 20016, United States
Unknown Facility
St Louis, Missouri, 63118, United States
Unknown Facility
Austin, Texas, 78756, United States
Unknown Facility
Irving, Texas, 75062, United States
Unknown Facility
Salvador, Estado de Bahia, 40325-090, Brazil
Unknown Facility
Aparecida de Goiânia, Goiás, 74922-810, Brazil
Unknown Facility
Curitiba, Paraná, 80430-050, Brazil
Unknown Facility
Curitiba, Paraná, 80520-000, Brazil
Unknown Facility
Rio de Janeiro, Rio de Janeiro, 21020-130, Brazil
Unknown Facility
São Paulo, São Paulo, 05403-010, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Daniel van Kammen, MD, PhD
ACADIA Pharmaceuticals Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 3, 2006
First Posted
August 7, 2006
Study Start
August 1, 2005
Study Completion
March 1, 2007
Last Updated
March 22, 2007
Record last verified: 2007-03