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

Depressive Disorder, Major Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141400
• Other study ID #: CN138-587
• Status: Completed
• Phase: N/A
• First received: June 9, 2010
• Last updated: November 7, 2013
• Start date: June 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48865
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	sensitivity to cost-sharing will be examined as a function of treatment resistance	16 months of medical and prescription drug coverage after the initial antidepressant prescription claim	16 months	No

External Links

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