Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00356655
Status:
TERMINATED
Last Update Posted:
2022-04-11
First Post:
2006-07-24
Brief Title:
The ACHIEVA Study of Enhanced Pharmacist Care on Antidepressant Use and Response
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
A COHORT AND INTERVENTION STUDY EVALUATING ANTIDEPRESSANT EPIDEMIOLOGY AND ADHERENCE The ACHIEVA Study
Status:
TERMINATED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This a comparative study of enhanced pharmacist care and regular care of patients starting on antidepressants When providing participants with enhanced care pharmacists will use the Health Professionals Antidepressant Communications Tool Health PACT a minimum of three times during face-to-face discussions This tool was developed specifically for this study All participants will be followed for 26 weeks and will be assessed for duration of use of their antidepressant adherence to treatment and clinical response
Detailed Description:
This proposal describes a combined observational study Phase I and randomized controlled trial Phase II The primary aim of the observational study is to determine the disorders in particular the types of depression for which family physicians prescribe antidepressants The primary aim of the randomized controlled trial RCT is to compare the effect of a brief psycho-educational intervention by pharmacists with usual care on antidepressant persistence
Subjects n621 phase 1 n106 phase 2 will be patients presenting to a pharmacy in Edmonton with a prescription for an antidepressant from a family physician and meeting the following criteria no antidepressants taken in the preceding six months 18 years of age or older and fluent in English Subjects will be interviewed using modified versions of the depression generalized anxiety disorder and panic disorder sections of the Diagnostic Interview Schedule the Beck Depression Inventory the Beck Anxiety Inventory and a question on recent stressful life events For Phase 1 the proportion of subjects with the following DSM-IV diagnoses will be estimated major depression minor depression generalized anxiety disorder panic disorder minor depression will be categorized into adjustment disorder with depressed mood and adjustment disorder with mixed anxiety and depressed mood The family doctor will be contacted and asked for the diagnosis that prompted the antidepressant prescription
Subjects with DSM IV depression will be invited to participate in Phase 2 Individuals will be randomized to a pharmacist intervention with the Health PACT or to usual care Using the newly-developed Antidepressant Compliance Questionnaire information on predictors of adherence will be collected at the baseline interview At weeks 4 8 16 and 26 subjects will be contacted by phone and questioned on antidepressant adherence and persistence At week 8 or the exit interview if a subject leaves the study early we will administer the Beck Depression Inventory and the Beck Anxiety Inventory The primary outcome is treatment persistence defined as the time to stop antidepressant use Adherence defined by the medication possession ratio MPR will be also be measured
Subjects n621 phase 1 n106 phase 2 will be patients presenting to a pharmacy in Edmonton with a prescription for an antidepressant from a family physician and meeting the following criteria no antidepressants taken in the preceding six months 18 years of age or older and fluent in English Subjects will be interviewed using modified versions of the depression generalized anxiety disorder and panic disorder sections of the Diagnostic Interview Schedule the Beck Depression Inventory the Beck Anxiety Inventory and a question on recent stressful life events For Phase 1 the proportion of subjects with the following DSM-IV diagnoses will be estimated major depression minor depression generalized anxiety disorder panic disorder minor depression will be categorized into adjustment disorder with depressed mood and adjustment disorder with mixed anxiety and depressed mood The family doctor will be contacted and asked for the diagnosis that prompted the antidepressant prescription
Subjects with DSM IV depression will be invited to participate in Phase 2 Individuals will be randomized to a pharmacist intervention with the Health PACT or to usual care Using the newly-developed Antidepressant Compliance Questionnaire information on predictors of adherence will be collected at the baseline interview At weeks 4 8 16 and 26 subjects will be contacted by phone and questioned on antidepressant adherence and persistence At week 8 or the exit interview if a subject leaves the study early we will administer the Beck Depression Inventory and the Beck Anxiety Inventory The primary outcome is treatment persistence defined as the time to stop antidepressant use Adherence defined by the medication possession ratio MPR will be also be measured
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None