ACP-104 in Acutely Psychotic Subjects With Schizophrenia
NCT ID: NCT00490516
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
247 participants
INTERVENTIONAL
2007-06-30
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
ACP-104
100 mg, tablet, BID, 6 weeks
2
ACP-104
200 mg, tablet, BID, 6 weeks
3
Placebo
placebo, tablet BID, 6 weeks
Interventions
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ACP-104
200 mg, tablet, BID, 6 weeks
ACP-104
100 mg, tablet, BID, 6 weeks
Placebo
placebo, tablet BID, 6 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
60 Years
ALL
No
Sponsors
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ACADIA Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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Anaheim, California, United States
Costa Mesa, California, United States
Covina, California, United States
Culver City, California, United States
Garden Grove, California, United States
Glendale, California, United States
Huntington Beach, California, United States
Oceanside, California, United States
Paramount, California, United States
Pasadena, California, United States
Pico Rivera, California, United States
Riverside, California, United States
San Diego, California, United States
Bradenton, Florida, United States
Kissimmee, Florida, United States
Atlanta, Georgia, United States
Baltimore, Maryland, United States
St Louis, Missouri, United States
Willingboro, New Jersey, United States
Philadelphia, Pennsylvania, United States
Austin, Texas, United States
Countries
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Other Identifiers
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ACP-104-003
Identifier Type: -
Identifier Source: org_study_id
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