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CompletedNCT01141400Updated Nov 8, 2013

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

An observational study in Depressive Disorder, Major, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2013-11-08.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
48,865
Ages
18 Years to 64 Years
Sex
All
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Study 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.

02

Conditions studied

  • Depressive Disorder, Major
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In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 48,865 is above the median of 150 across 653 observational studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.

Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
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)

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

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
48,865 participants (actual)

Groups and cohorts

  • depression & initial prescription for an antidepressant

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

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What researchers measure

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

    Time frame: 16 months

Secondary outcomes

  1. 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

    Time frame: 16 months

07

Study locations

No study locations are listed for this record.

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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01141400
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka Pharmaceutical Co., Ltd.
First posted
Jun 10, 2010
Start date
Jun 2009
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Nov 8, 2013

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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