The Effect of Patient Cost-Sharing on Antidepressant and Adjunctive Therapy Use

NCT01141400 | Completed

• 1 other identifier: CN138-587
• Study Type: observational
• Target: 48,865
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• 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).

  16 months of medical and prescription drug coverage after the initial antidepressant prescription claim

  16 months

Secondary Outcomes (1)

• sensitivity to cost-sharing will be examined as a function of treatment resistance

  16 months

Study Arms (1)

depression & initial prescription for an antidepressant

A sample of adults with a diagnosis of depression and an initial prescription fill for an antidepressant

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Related Links

• BMS Clinical Trials Disclosure
• Investigator Inquiry form
• For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 10, 2010
• Study Start: June 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 8, 2013

Record last verified: 2010-11