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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ACP-103
Sponsored by
ACADIA Pharmaceuticals Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, psychosis, delusions, hallucination

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Total score on the Positive and Negative Symptom Scale (PANSS).

Secondary Outcome Measures

Clinical Global Impression-Severity (CGI-S), Simpson Angus Scale (SAS), Barnes Akathisia Scale (BAS), Calgary Depression Scale for Schizophrenia (CDSS)

Full Information

First Posted
August 3, 2006
Last Updated
March 20, 2007
Sponsor
ACADIA Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00361166
Brief Title
Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol and Risperidone
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 Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ACADIA Pharmaceuticals Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, psychosis, delusions, hallucination

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ACP-103
Primary Outcome Measure Information:
Title
Total score on the Positive and Negative Symptom Scale (PANSS).
Secondary Outcome Measure Information:
Title
Clinical Global Impression-Severity (CGI-S), Simpson Angus Scale (SAS), Barnes Akathisia Scale (BAS), Calgary Depression Scale for Schizophrenia (CDSS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel van Kammen, MD, PhD
Organizational Affiliation
ACADIA Pharmaceuticals Inc.
Official's Role
Study Chair
Facility Information:
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92126
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
City
Salvador
State/Province
BA
ZIP/Postal Code
40325-090
Country
Brazil
City
Aparecida de Goiânia
State/Province
GO
ZIP/Postal Code
74922-810
Country
Brazil
City
Curitiba
State/Province
PR
ZIP/Postal Code
80430-050
Country
Brazil
City
Curitiba
State/Province
PR
ZIP/Postal Code
80520-000
Country
Brazil
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21020-130
Country
Brazil
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil

12. IPD Sharing Statement

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

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