Antipsychotic Medication Extended Dosing Study

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Schizophrenia	Procedure: dosing	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Antipsychotic Medication Extended Dosing Study
Study Start Date :	August 2002
Actual Primary Completion Date :	June 2007
Actual Study Completion Date :	October 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Remington G, Seeman P, Feingold A, Mann S, Shammi C, Kapur S. "Extended" antipsychotic dosing in the maintenance treatment of schizophrenia: a double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Aug;72(8):1042-8. doi: 10.4088/JCP.09m05866yel. Epub 2010 Sep 7.

Responsible Party:	Dr. Gary Remington, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:	NCT00431574 History of Changes
Other Study ID Numbers:	234/2003
First Posted:	February 6, 2007
Last Update Posted:	February 26, 2008
Last Verified:	February 2008

Keywords provided by Centre for Addiction and Mental Health:

schizophrenia; schizoaffective; antipsychotic; randomized control trial

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Antipsychotic Agents	Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs