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Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol and Risperidone

Information source: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: ACP-103 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: ACADIA Pharmaceuticals Inc.

Official(s) and/or principal investigator(s):
Daniel van Kammen, MD, PhD, Study Chair, Affiliation: ACADIA Pharmaceuticals Inc.

Summary

The primary purpose of this study is to determine whether a combination of ACP-103 (the study medication) with either haloperidol or risperidone will show antipsychotic efficacy and that it is safe and well tolerated. Further purposes of this study are to determine whether ACP-103, in combination with either haloperidol or risperidone, will enhance their antipsychotic effectiveness, demonstrate effectiveness against the negative symptoms, improve motoric tolerability, and is safe and well tolerated. This is a seven-week study (one week screening and six weeks of study medication) where a total of 400 patients who meet entrance criteria will randomly be assigned to receive one of five groups of study treatments of either low dose haloperidol plus ACP-103, low dose haloperidol plus placebo (a substance similar to a sugar pill), low dose risperidone plus ACP-103, low dose risperidone plus placebo, or high dose risperidone plus placebo. The study will begin with with a three to seven day drug-free period followed by six weeks of a stable daily dosage of study medication. Study subjects will be treated as hospital in-patients during screening and for the first 14 days of the study. Study subjects will be closely monitored throughout the study.

Clinical Details

Official title: A Randomized, Double Blind, Multi-Center Study to Assess the Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol or Risperidone to Schizophrenic Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Total score on the Positive and Negative Symptom Scale (PANSS).

Secondary outcome: Clinical Global Impression-Severity (CGI-S), Simpson Angus Scale (SAS), Barnes Akathisia Scale (BAS), Calgary Depression Scale for Schizophrenia (CDSS)

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- male or female subjects ages 18-65 diagnosed with schizophrenia

- experiencing an acute exacerbation of psychosis

- has had prior response to antipsychotic therapy within the previous 3 years

- female subjects must be of non-childbearing potential or must comply with

double-barrier protection methods against conception

- ability of subject or caregiver or legally authorized representative to provide

informed consent

- subjects must be hospitalized at screening and must be willing to remain in the

hospital at least 14 days after baseline and must comply with all study events through completion of the study Exclusion Criteria:

- inability of the subject or caregiver or legally authorized representative to provide

consent

- any female subject who is pregnant or breast feeding

- any subject with concurrent mental illness or disability

- any subject considered to be a danger to themselves or others

- recent use of certain antipsychotics or other medications that might interfere with

this study's medication

- abnormal clinical laboratory values

- presence, or recent history, of serious medical conditions or drug abuse

- likely allergy or sensitivity to ACP-103, haloperidol, or risperidone, based on known

allergies to drugs of the same class

- any subject who has participated in a prior clinical trial of ACP-103

- any subject judged by the Principal Investigator to be inappropriate for the study

Locations and Contacts

Salvador, BA 40325-090, Brazil

Cerritos, California 90703, United States

Garden Grove, California 92845, United States

Glendale, California 91206, United States

Paramount, California 90723, United States

Pico Rivera, California 90660, United States

San Diego, California 92126, United States

San Diego, California 92123, United States

Washington, District of Columbia 20016, United States

Aparecida de Goiânia, GO 74922-810, Brazil

St. Louis, Missouri 63118, United States

Curitiba, PR 80430-050, Brazil

Curitiba, PR 80520-000, Brazil

Rio de Janeiro, RJ 21020-130, Brazil

São Paulo, SP 05403-010, Brazil

Austin, Texas 78756, United States

Irving, Texas 75062, United States

Additional Information

Starting date: August 2005
Last updated: March 20, 2007

Page last updated: August 23, 2015

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