ACP-104 in Acutely Psychotic Subjects With Schizophrenia - Full Text View

Sponsor:	ACADIA Pharmaceuticals Inc.
Information provided by:	ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00490516

Purpose

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	Intervention	Phase
Schizophrenia	Drug: ACP-104 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Psychotic Disorders Schizophrenia

U.S. FDA Resources

Further study details as provided by ACADIA Pharmaceuticals Inc.:

Primary Outcome Measures:

PANSS [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	250
Study Start Date:	June 2007
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: ACP-104 100 mg, tablet, BID, 6 weeks
2: Experimental	Drug: ACP-104 200 mg, tablet, BID, 6 weeks
3: Placebo Comparator	Drug: Placebo placebo, tablet BID, 6 weeks

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490516

Locations

United States, California

San Diego, California, United States, 92108

Garden Grove, California, United States, 92845

Culver City, California, United States, 90232

Paramount, California, United States, 90723

Glendale, California, United States, 91206

Covina, California, United States, 91724

Anaheim, California, United States, 92805

Pico Rivera, California, United States, 90660

Pasadena, California, United States, 91107

Oceanside, California, United States, 92056

Riverside, California, United States, 92506

Huntington Beach, California, United States, 92647

Costa Mesa, California, United States, 92626
United States, Florida

Bradenton, Florida, United States, 34208

Kissimme, Florida, United States, 34741
United States, Georgia

Atlanta, Georgia, United States, 30308
United States, Maryland

Baltimore, Maryland, United States, 21202
United States, Missouri

St. Louis, Missouri, United States, 63118
United States, New Jersey

Willingboro, New Jersey, United States, 08046
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19139
United States, Texas

Austin, Texas, United States, 78754

Sponsors and Collaborators

ACADIA Pharmaceuticals Inc.

More Information

No publications provided

Responsible Party:	ACADIA Pharmaceuticals Inc. ( Sue Vetuschi )
Study ID Numbers:	ACP-104-003
Study First Received:	June 21, 2007
Last Updated:	February 22, 2008
ClinicalTrials.gov Identifier:	NCT00490516 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by ACADIA Pharmaceuticals Inc.:

Schizophrenia, psychotic disorders

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 08, 2010