- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00361166
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
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.
Study Overview
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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BA
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Salvador, BA, Brazil, 40325-090
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GO
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Aparecida de Goiânia, GO, Brazil, 74922-810
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PR
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Curitiba, PR, Brazil, 80430-050
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Curitiba, PR, Brazil, 80520-000
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RJ
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Rio de Janeiro, RJ, Brazil, 21020-130
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SP
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São Paulo, SP, Brazil, 05403-010
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California
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Cerritos, California, United States, 90703
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Garden Grove, California, United States, 92845
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Glendale, California, United States, 91206
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Paramount, California, United States, 90723
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Pico Rivera, California, United States, 90660
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San Diego, California, United States, 92123
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San Diego, California, United States, 92126
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District of Columbia
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Washington, District of Columbia, United States, 20016
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Missouri
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St. Louis, Missouri, United States, 63118
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Texas
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Austin, Texas, United States, 78756
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Irving, Texas, United States, 75062
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Total score on the Positive and Negative Symptom Scale (PANSS).
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Secondary Outcome Measures
Outcome Measure |
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Clinical Global Impression-Severity (CGI-S), Simpson Angus Scale (SAS), Barnes Akathisia Scale (BAS), Calgary Depression Scale for Schizophrenia (CDSS)
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Daniel van Kammen, MD, PhD, ACADIA Pharmaceuticals Inc.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Pimavanserin
Other Study ID Numbers
- ACP-103-008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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