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

This study has been completed.
Information provided by:
ACADIA Pharmaceuticals Inc. Identifier:
First received: August 3, 2006
Last updated: March 20, 2007
Last verified: March 2007

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.

Condition Intervention Phase
Drug: ACP-103
Phase 2

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

Resource links provided by NLM:

Further study details as provided by ACADIA Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Total score on the Positive and Negative Symptom Scale (PANSS).

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

Estimated Enrollment: 400
Study Start Date: August 2005
Study Completion Date: March 2007

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00361166

United States, California
Cerritos, California, United States, 90703
Garden Grove, California, United States, 92845
Glendale, California, United States, 91206
Paramount, California, United States, 90723
Pico Rivera, California, United States, 90660
San Diego, California, United States, 92126
San Diego, California, United States, 92123
United States, District of Columbia
Washington, District of Columbia, United States, 20016
United States, Missouri
St. Louis, Missouri, United States, 63118
United States, Texas
Austin, Texas, United States, 78756
Irving, Texas, United States, 75062
Salvador, BA, Brazil, 40325-090
Aparecida de Goiânia, GO, Brazil, 74922-810
Curitiba, PR, Brazil, 80430-050
Curitiba, PR, Brazil, 80520-000
Rio de Janeiro, RJ, Brazil, 21020-130
São Paulo, SP, Brazil, 05403-010
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
Study Chair: Daniel van Kammen, MD, PhD ACADIA Pharmaceuticals Inc.
  More Information Identifier: NCT00361166     History of Changes
Other Study ID Numbers: ACP-103-008 
Study First Received: August 3, 2006
Last Updated: March 20, 2007
Health Authority: United States: Food and Drug Administration
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research

Keywords provided by ACADIA Pharmaceuticals Inc.:

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Antipsychotic Agents
Anti-Dyskinesia Agents
Antiparkinson Agents
Autonomic Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Agonists
Serotonin Agents
Serotonin Receptor Agonists
Tranquilizing Agents processed this record on May 26, 2016