The ACHIEVA Study of Enhanced Pharmacist Care on Antidepressant Use and Response
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00356655|
Recruitment Status : Terminated (Low recruitment)
First Posted : July 26, 2006
Last Update Posted : May 14, 2008
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder||Behavioral: Psychoeducation||Not Applicable|
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 (n=621 phase 1, n=106 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A COHORT AND INTERVENTION STUDY EVALUATING ANTIDEPRESSANT EPIDEMIOLOGY AND ADHERENCE: The ACHIEVA Study|
|Study Start Date :||July 2006|
|Estimated Study Completion Date :||January 2009|
- Adherence (mean possession ratio)
- Beck Depression Inventory symptom improvement
- Beck Anxiety Inventory symptom improvement
- Change in antidepressant compliance questionnaire responses
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356655
|Edmonton, Alberta, Canada, T6G 2C8|
|Principal Investigator:||David M Gardner, PharmD||Dalhousie University|