Antipsychotic Medication Extended Dosing Study
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Aug 2002
Longer than P75 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 2, 2007
CompletedFirst Posted
Study publicly available on registry
February 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFebruary 7, 2024
February 1, 2008
4.8 years
February 2, 2007
February 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- exposure to depot antipsychotic during 12 months prior to enrollment
- substance-related disorders according to DSM-IV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8, Canada
Related Publications (1)
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.
PMID: 20868639DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary J Remington, MD, PhD
Centre for Addiction and Mental Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2007
First Posted
February 6, 2007
Study Start
August 1, 2002
Primary Completion
June 1, 2007
Study Completion
October 1, 2007
Last Updated
February 7, 2024
Record last verified: 2008-02