The Effect of Patient Cost-Sharing on Antidepressant and Adjunctive Therapy Use
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01141400
First received: June 9, 2010
Last updated: November 30, 2010
Last verified: November 2010
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Purpose
The primary objective of this study is to measure the effects of patient cost-sharing on the initiation of adjunctive treatment and subsequent healthcare utilization and expenditures among a population of commercially insured adults on antidepressant therapy.
| Condition |
|---|
|
Depressive Disorder, Major |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | The Effect of Patient Cost-Sharing on Antidepressant and Adjunctive Therapy Use |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- The primary outcome is any use of adjunctive treatment (combined and by class) and the time to initiation of adjunctive treatment (combined and by class). [ Time Frame: 16 months ] [ Designated as safety issue: No ]16 months of medical and prescription drug coverage after the initial antidepressant prescription claim
Secondary Outcome Measures:
- sensitivity to cost-sharing will be examined as a function of treatment resistance [ Time Frame: 16 months ] [ Designated as safety issue: No ]16 months of medical and prescription drug coverage after the initial antidepressant prescription claim
| Enrollment: | 48865 |
| Study Start Date: | June 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
depression & initial prescription for an antidepressant
A sample of adults with a diagnosis of depression and an initial prescription fill for an antidepressant
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients will be selected from the MarketScan Commercial Database between January 1, 2004 and September 30, 2008 (the last month of data available)
Criteria
Inclusion Criteria:
- Adult patients (aged 18-64) will be selected from the MarketScan Commercial Database between January 1, 2004, and September 30, 2008, if they have at least two medical claims with a diagnosis of depression and at least one prescription fill for an antidepressant medication.
Exclusion Criteria:
- Patients who have any claim with a diagnosis of dementia, schizophrenia, delusional disorder, psychoses, pervasive development disorder, mental retardation, cerebral degenerations, Parkinson's disease, senility, manic depression, bipolar disorder, or major depressive disorder with psychotic symptoms.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01141400 History of Changes |
| Other Study ID Numbers: | CN138-587 |
| Study First Received: | June 9, 2010 |
| Last Updated: | November 30, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms |
Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013