ACP-104 in Acutely Psychotic Subjects With Schizophrenia

Sponsor

ACADIA Pharmaceuticals Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00490516

Collaborator

(none)

247

Enrollment

Locations

Arms

Duration (Months)

11.8

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, double-blind, placebo-controlled parallel-group, 6-week study, evaluating two dose levels of ACP-104 or Placebo twice a day in patients with schizophrenia who are experiencing an acute psychotic episode.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: ACP-104 Drug: ACP-104 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

247 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Six-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase II Study of the Efficacy and Safety of ACP-104 in Acutely Psychotic Subjects With Schizophrenia

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: ACP-104 100 mg, tablet, BID, 6 weeks
Experimental: 2	Drug: ACP-104 200 mg, tablet, BID, 6 weeks
Placebo Comparator: 3	Drug: Placebo placebo, tablet BID, 6 weeks

Arm

Intervention/Treatment

Experimental: 1

Drug: ACP-104

100 mg, tablet, BID, 6 weeks

Experimental: 2

Drug: ACP-104

200 mg, tablet, BID, 6 weeks

Placebo Comparator: 3

Drug: Placebo

placebo, tablet BID, 6 weeks

Outcome Measures

Primary Outcome Measures

PANSS [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female; 18-60 years of age
The subject is physically healthy and medically stable.
The subject is able to provide informed consent
The subject has been diagnosed with schizophrenia for at least 1 year
Currently experiencing an acute episode of psychosis
The subject is willing to comply with all study-related events including in-patient hospitalization for at least 3 weeks.
The subject has a caregiver who is willing and able to support the subject to ensure compliance with treatment and outpatient visits.
If the subject is female, subject must be of non-childbearing potential - OR- if she is capable of becoming pregnant, agrees to commit to use one of the approved methods of contraception, as defined by the protocol.

Exclusion Criteria:

If the subject is a pregnant or lactating (breast-feeding) female.
The subject has a significant risk of suicide, homicide, and/or harm to self or others.
Subject's psychotic symptoms have not improved with a therapeutic dose of antipsychotic treatment over the last 2 years.
The subject is experiencing his/her first episode of schizophrenia.
The subject has another psychotic disorder or has a history of autistic disorder or other pervasive developmental disorder (for example, mental retardation).
The subject has been prescribed or exposed to clozapine before.
The subject has donated blood or plasma within 56 days prior to the Screening Visit.
The subject has participated in any clinical study within 30 days prior to the Screening Visit.

In addition to the criteria described above, subjects will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of the subject's health, including psychosis (mental health -the extent to which subject is unable to think clearly), heart condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline condition does not meet all protocol-specified entry criteria).

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Anaheim	California	United States	92805
2	Costa Mesa	California	United States	92626
3	Covina	California	United States	91724
4	Culver City	California	United States	90232
5	Garden Grove	California	United States	92845
6	Glendale	California	United States	91206
7	Huntington Beach	California	United States	92647
8	Oceanside	California	United States	92056
9	Paramount	California	United States	90723
10	Pasadena	California	United States	91107
11	Pico Rivera	California	United States	90660
12	Riverside	California	United States	92506
13	San Diego	California	United States	92108
14	Bradenton	Florida	United States	34208
15	Kissimmee	Florida	United States	34741
16	Atlanta	Georgia	United States	30308
17	Baltimore	Maryland	United States	21202
18	Saint Louis	Missouri	United States	63118
19	Willingboro	New Jersey	United States	08046
20	Philadelphia	Pennsylvania	United States	19139
21	Austin	Texas	United States	78754

Sponsors and Collaborators

ACADIA Pharmaceuticals Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ACADIA Pharmaceuticals Inc.

ClinicalTrials.gov Identifier:

NCT00490516

Other Study ID Numbers:

ACP-104-003

First Posted:

Jun 22, 2007

Last Update Posted:

Apr 20, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by ACADIA Pharmaceuticals Inc.

Schizophrenia, psychotic disorders

Additional relevant MeSH terms:

Schizophrenia

Mental Disorders

Psychotic Disorders

Study Results

No Results Posted as of Apr 20, 2017