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

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ClinicalTrials.gov Identifier: NCT01141400
Recruitment Status : Completed
First Posted : June 10, 2010
Last Update Posted : November 8, 2013
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

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.

Condition or disease
Depressive Disorder, Major

Study Type : Observational
Actual Enrollment : 48865 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Effect of Patient Cost-Sharing on Antidepressant and Adjunctive Therapy Use
Study Start Date : June 2009
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources

Group/Cohort
depression & initial prescription for an antidepressant
A sample of adults with a diagnosis of depression and an initial prescription fill for an antidepressant



Primary Outcome Measures :
  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). [ Time Frame: 16 months ]
    16 months of medical and prescription drug coverage after the initial antidepressant prescription claim


Secondary Outcome Measures :
  1. sensitivity to cost-sharing will be examined as a function of treatment resistance [ Time Frame: 16 months ]
    16 months of medical and prescription drug coverage after the initial antidepressant prescription claim



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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): NCT01141400


Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01141400     History of Changes
Other Study ID Numbers: CN138-587
First Posted: June 10, 2010    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2010

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs