ACP-104 in Acutely Psychotic Subjects With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00490516
First received: June 21, 2007
Last updated: February 22, 2008
Last verified: February 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Anaheim, California, United States, 92805
Costa Mesa, California, United States, 92626
Covina, California, United States, 91724
Culver City, California, United States, 90232
Garden Grove, California, United States, 92845
Glendale, California, United States, 91206
Huntington Beach, California, United States, 92647
Oceanside, California, United States, 92056
Paramount, California, United States, 90723
Pasadena, California, United States, 91107
Pico Rivera, California, United States, 90660
Riverside, California, United States, 92506
San Diego, California, United States, 92108
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: Sue Vetuschi, ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00490516     History of Changes
Other Study ID Numbers: ACP-104-003
Study First Received: June 21, 2007
Last Updated: February 22, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by ACADIA Pharmaceuticals Inc.:
Schizophrenia, psychotic disorders

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 19, 2014