Depressive Disorder, MajorNCT01141400
The Effect of Patient Cost-Sharing on Antidepressant and Adjunctive Therapy Use
An observational study of Depressive Disorder, Major, run by Otsuka Pharmaceutical Development & Commercialization, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depressive Disorder, Major
- How many people
- 48,865 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
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)
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| depression & initial prescription for an antidepressant | A sample of adults with a diagnosis of depression and an initial prescription fill for an antidepressant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJun 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 48,865 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141400
- Sponsor's protocol ID
- CN138-587
- Status last verified
- Nov 2010
- First submitted
- 9 Jun 2010
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Patient Cost-Sharing on Antidepressant and Adjunctive Therapy Use
- ClinicalTrials.gov ID
- NCT01141400
- Acronym / sponsor ID
- CN138-587
- Conditions
- Depressive Disorder, Major
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48,865 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Jun 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| depression & initial prescription for an antidepressant | – | –A sample of adults with a diagnosis of depression and an initial prescription fill for an antidepressant |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
sensitivity to cost-sharing will be examined as a function of treatment resistance
Time frame: 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htmLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Major, run by Otsuka Pharmaceutical Development & Commercialization, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013.