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

Sponsor

ACADIA Pharmaceuticals Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00361166

Collaborator

(none)

400

Enrollment

Locations

Duration (Months)

23.5

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: ACP-103	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2005

Actual Study Completion Date :

Mar 1, 2007

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Cerritos	California	United States	90703
2	Garden Grove	California	United States	92845
3	Glendale	California	United States	91206
4	Paramount	California	United States	90723
5	Pico Rivera	California	United States	90660
6	San Diego	California	United States	92123
7	San Diego	California	United States	92126
8	Washington	District of Columbia	United States	20016
9	St. Louis	Missouri	United States	63118
10	Austin	Texas	United States	78756
11	Irving	Texas	United States	75062
12	Salvador	BA	Brazil	40325-090
13	Aparecida de Goiânia	GO	Brazil	74922-810
14	Curitiba	PR	Brazil	80430-050
15	Curitiba	PR	Brazil	80520-000
16	Rio de Janeiro	RJ	Brazil	21020-130
17	São Paulo	SP	Brazil	05403-010