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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: ACP-104; Drug: ACP-104; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Phase 2

Contacts and Locations

Study 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
  • Florida
    • Bradenton, Florida, United States, 34208
    • Kissimmee, Florida, United States, 34741
  • Georgia
    • Atlanta, Georgia, United States, 30308
  • Maryland
    • Baltimore, Maryland, United States, 21202
  • Missouri
    • Saint Louis, Missouri, United States, 63118
  • New Jersey
    • Willingboro, New Jersey, United States, 08046
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19139
  • Texas
    • Austin, Texas, United States, 78754

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	Drug: ACP-104; 200 mg, tablet, BID, 6 weeks; Drug: ACP-104; 100 mg, tablet, BID, 6 weeks
EXPERIMENTAL: 2	Drug: ACP-104; 200 mg, tablet, BID, 6 weeks; Drug: ACP-104; 100 mg, tablet, BID, 6 weeks
PLACEBO_COMPARATOR: 3	Drug: Placebo; placebo, tablet BID, 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PANSS	6 weeks

Collaborators and Investigators

• Sponsor: ACADIA Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (ACTUAL): February 1, 2008
• Study Completion (ACTUAL): February 1, 2008

Study Registration Dates

• First Submitted: June 21, 2007
• First Submitted That Met QC Criteria: June 21, 2007
• First Posted (ESTIMATE): June 22, 2007

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Schizophrenia, psychotic disorders
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: ACP-104-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No