ACP-104 in Acutely Psychotic Subjects With Schizophrenia

NCT00490516 | Completed Phase 2 FDA Drug

• 1 other identifier: ACP-104-003
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 21

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.

Conditions

Schizophrenia

Keywords

Schizophrenia, psychotic disorders

Outcome Measures

Primary Outcomes (1)

• PANSS

  6 weeks

Study Arms (3)

1

EXPERIMENTAL

Drug: ACP-104

2

EXPERIMENTAL

Drug: ACP-104

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ACP-104 DRUG

200 mg, tablet, BID, 6 weeks

2

Placebo DRUG

placebo, tablet BID, 6 weeks

3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (21)

Unknown Facility

Anaheim, California, 92805, United States

Location

Unknown Facility

Costa Mesa, California, 92626, United States

Location

Unknown Facility

Covina, California, 91724, United States

Location

Unknown Facility

Culver City, California, 90232, United States

Location

Unknown Facility

Garden Grove, California, 92845, United States

Location

Unknown Facility

Glendale, California, 91206, United States

Location

Unknown Facility

Huntington Beach, California, 92647, United States

Location

Unknown Facility

Oceanside, California, 92056, United States

Location

Unknown Facility

Paramount, California, 90723, United States

Location

Unknown Facility

Pasadena, California, 91107, United States

Location

Unknown Facility

Pico Rivera, California, 90660, United States

Location

Unknown Facility

Riverside, California, 92506, United States

Location

Unknown Facility

San Diego, California, 92108, United States

Location

Unknown Facility

Bradenton, Florida, 34208, United States

Location

Unknown Facility

Kissimmee, Florida, 34741, United States

Location

Unknown Facility

Atlanta, Georgia, 30308, United States

Location

Unknown Facility

Baltimore, Maryland, 21202, United States

Location

Unknown Facility

St Louis, Missouri, 63118, United States

Location

Unknown Facility

Willingboro, New Jersey, 08046, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19139, United States

Location

Unknown Facility

Austin, Texas, 78754, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2007
• First Posted: June 22, 2007
• Study Start: June 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)