Antipsychotic Medication Extended Dosing Study - Full Text View

Sponsors and Collaborators:	Centre for Addiction and Mental Health National Alliance for Research on Schizophrenia and Depression
Information provided by:	Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:	NCT00431574

Purpose

In patients stabilized on their antipsychotic and demonstrating evidence of good clinical response, there will not be a significant change in symptoms if their medication is decreased to every 2 days rather than daily. This decrease in antipsychotic exposure will lead to a reduction in side effects, as well as improved subjective response to treatment.

Condition	Intervention
Schizophrenia	Procedure: dosing

MedlinePlus related topics: Mental Health Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Antipsychotic Medication Extended Dosing Study

Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:

Clinical Global Impression every 2 weeks
Simpson and Angus Rating Scale for Extrapyramidal Effects every 2 weeks
Barnes Rating Scale for Drug-Induced Akathisia every 2 weeks
Abnormal Involuntary Movement Scale every 2 weeks
Drug Attitude Inventory every 2 weeks
Calgary Depression Scale for Schizophrenia every 2 weeks
Brief Psychiatric Rating Scale every 2 weeks

Estimated Enrollment:	40
Study Start Date:	August 2002
Study Completion Date:	October 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Detailed Description:

The present study is a 6-month, double-blind study of patients with schizophrenia stabilized on their current antipsychotic (monotherapy) for a period of at least 3 months. After providing informed consent, individuals will be randomly assigned to 1 of 2 treatment arms: regular daily antipsychotic dosing or active medication at the same daily dose every 2nd day. Various scales to measure clinical response and side effects will be administered at baseline, as well as every 2 weeks thereafter. Subjective scales will also be employed, and lab evaluations will include plasma antipsychotic levels at baseline and endpoint, as well as prolactin. Our sample size will be 20/group.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

DSM-IV diagnosis of schizophrenia or schizo-affective disorder
Capacity to provide written, informed consent
Stabilized* on a single oral antipsychotic for at least three months (excluding CLOZAPINE or QUETIAPINE)
Evidence of compliance with previous antipsychotic treatment, i.e. greater than 90%
- defined as 2 consecutively identical CGI evaluations (screening and baseline, at least one week apart)

Exclusion Criteria:

exposure to depot antipsychotic during 12 months prior to enrollment
substance-related disorders according to DSM-IV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431574

Locations

Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8

Sponsors and Collaborators

Centre for Addiction and Mental Health

National Alliance for Research on Schizophrenia and Depression

Investigators

Principal Investigator:

Gary J Remington, MD, PhD

Centre for Addiction and Mental Health

More Information

No publications provided

Responsible Party:	Centre for Addiction and Mental Health ( Dr. Gary Remington )
Study ID Numbers:	234/2003
Study First Received:	February 2, 2007
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00431574 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:

schizophrenia
schizoaffective
antipsychotic
randomized control trial

Study placed in the following topic categories:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Psychotropic Drugs

Central Nervous System Depressants
Psychotic Disorders
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009