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

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.

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Key information

Conditions

Schizophrenia Behavior Behavioral Symptoms Delusions Hallucinations Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Salvador, Estado de Bahia, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACP-103

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

ACADIA Pharmaceuticals Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2005
Study completion: 2007
First posted: Aug 7, 2006
Registry last updated: Mar 22, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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