Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 21, 2007
February 22, 2008
June 2007
February 2008   (final data collection date for primary outcome measure)
PANSS [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00490516 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
ACP-104 in Acutely Psychotic Subjects With Schizophrenia
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: ACP-104
    200 mg, tablet, BID, 6 weeks
  • Drug: ACP-104
    100 mg, tablet, BID, 6 weeks
  • Drug: Placebo
    placebo, tablet BID, 6 weeks
  • Experimental: 1
    Intervention: Drug: ACP-104
  • Experimental: 2
    Intervention: Drug: ACP-104
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
Not Provided
February 2008   (final data collection date for primary outcome measure)

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).

Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00490516
ACP-104-003
Not Provided
Sue Vetuschi, ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Not Provided
Not Provided
ACADIA Pharmaceuticals Inc.
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP