Clinical trial NCT00431574: Antipsychotic Medication Extended Dosing Study
Official title: Antipsychotic Medication Extended Dosing Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
schizoaffective
antipsychotic
randomized control trial
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2007-02-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Clinical Global Impression every 2 weeks
measure: Simpson and Angus Rating Scale for Extrapyramidal Effects every 2 weeks
measure: Barnes Rating Scale for Drug-Induced Akathisia every 2 weeks
measure: Abnormal Involuntary Movement Scale every 2 weeks
measure: Drug Attitude Inventory every 2 weeks
measure: Calgary Depression Scale for Schizophrenia every 2 weeks
measure: Brief Psychiatric Rating Scale every 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Gary J Remington, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.