Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol and Risperidone
Information source: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: ACP-103 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: ACADIA Pharmaceuticals Inc. Official(s) and/or principal investigator(s):
Daniel van Kammen, MD, PhD, Study Chair, Affiliation: ACADIA Pharmaceuticals Inc.
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Total score on the Positive and Negative Symptom Scale (PANSS).
Secondary outcome: Clinical Global Impression-Severity (CGI-S), Simpson Angus Scale (SAS), Barnes Akathisia Scale (BAS), Calgary Depression Scale for Schizophrenia (CDSS)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Salvador, BA 40325-090, Brazil
Cerritos, California 90703, United States
Garden Grove, California 92845, United States
Glendale, California 91206, United States
Paramount, California 90723, United States
Pico Rivera, California 90660, United States
San Diego, California 92126, United States
San Diego, California 92123, United States
Washington, District of Columbia 20016, United States
Aparecida de Goiânia, GO 74922-810, Brazil
St. Louis, Missouri 63118, United States
Curitiba, PR 80430-050, Brazil
Curitiba, PR 80520-000, Brazil
Rio de Janeiro, RJ 21020-130, Brazil
São Paulo, SP 05403-010, Brazil
Austin, Texas 78756, United States
Irving, Texas 75062, United States
Additional Information
Starting date: August 2005
Last updated: March 20, 2007
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