Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol and Risperidone

This study has been completed.
Sponsor:
Information provided by:
ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00361166
First received: August 3, 2006
Last updated: March 20, 2007
Last verified: March 2007

August 3, 2006
March 20, 2007
August 2005
Not Provided
Total score on the Positive and Negative Symptom Scale (PANSS).
Same as current
Complete list of historical versions of study NCT00361166 on ClinicalTrials.gov Archive Site
Clinical Global Impression-Severity (CGI-S), Simpson Angus Scale (SAS), Barnes Akathisia Scale (BAS), Calgary Depression Scale for Schizophrenia (CDSS)
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Schizophrenia
Drug: ACP-103
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
March 2007
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil
 
NCT00361166
ACP-103-008
Not Provided
Not Provided
ACADIA Pharmaceuticals Inc.
Not Provided
Study Chair: Daniel van Kammen, MD, PhD ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP