Depressive Disorder, Treatment-ResistantNCT03109002
An Epidemiology Study of Treatment Resistant Depression in the United States (US)
An observational study of Depressive Disorder, Treatment-Resistant, run by Janssen Research & Development, LLC.
Trial summary
The purpose of this study is to describe the epidemiology of Treatment Resistant Depression (TRD) in the US, including the population incidence of TRD, and TRD as a proportion of Pharmacologically Treated Depression (PTD), and stratify the estimates by sex and age group, with separate estimates for the Medicaid… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Depressive Disorder, Treatment-Resistant
- How many people
- 200,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2017to 18 May 2017
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: US residents with medical insurance between 1 Jan, 2010 and 31 Dec, 2014 will be assessed.
Who may be able to join
- Have been in the database for the past year (ignoring breaks of < 30 days)
- Have not had, an excluded diagnosis or dispensing of an AD medication during the past year
- Are aged 14 to 60 years (if in the CCAE or MCDC databases), or are aged greater than or equal to (>=) 65 years (if in the MCDR database). Age is defined as age on Jan 1, 2011. The boundary at age 60 for the first two databases is intended to avoid loss to follow-up due to transfer to Medicare at age 65. The boundary at age 65 for the MCDR database reflects the fact that very few people described by that database are aged less than 65
Who cannot join
- Participants will be excluded when they receive diagnoses Schizophrenia, Bipolar disorder including mania or Dementia
About this study
Official title: Epidemiology of Treatment Resistant Depression in the US: Analysis of Health Services Databases
The purpose of this study is to describe the epidemiology of Treatment Resistant Depression (TRD) in the US, including the population incidence of TRD, and TRD as a proportion of Pharmacologically Treated Depression (PTD), and stratify the estimates by sex and age group, with separate estimates for the Medicaid population, the Medicare population, and the privately insured population. Anonymized participants data will be used for the analysis.
- Conditions
- Depressive Disorder, Treatment-Resistant
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
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 |
|---|---|---|
| Cohort: Pharmacologically Treated Depression (PTD) Cases | This study is based on anonymized health services data, study population include US residents with medical insurance between 1 Jan, 2010 and 31 Dec, 2014 as described by the Truven MarketScan Medicaid (MDCD), Truven MarketScan Medicare Supplemental (MCDR), and Truven MarketScan Commercial Claims and Encounters (CCAE) databases. Within each database, pharmacologically treated depression (PTD) cases incident during 2011 will be followed for up to 4 years to ascertain their TRD status and 1-year incidence rates for PTD and TRD. Participants will not receive any intervention as a part of this study. To assure they are incident rather than prevalent cases, study participants are required to have 1 year without a dispensing of an antidepressant medication before they can join the cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Treatment Resistant Depression
TRD will be defined as the failure of two medications, as marked by their replacement or supplementation with other medications using three alternative definitions. In one the time for a medication regimen to fail is limited to less than or equal to (<=) 3 months and in the second the time for a medication regimen to fail is limited to <= 6 months, both corresponding to the medication never providing adequate relief. In the third, the time for a medication regimen to fail will be limited to <= 2 years, corresponding to the medication not providing permanent or very long lasting relief.
Measured: Up to 4 years
Treatment Resistant Depression as a Proportion of Pharmacologically Treated Depression
An episode of PTD begins when a member of the study cohort receives a dispensing of an antidepressant (AD) medication and receives a diagnosis of depression between 180 days before that dispensing and 30 days after that dispensing.
Measured: Up to 4 years
Incidence Rate of Treatment Resistant Depression by Age Group and Sex
TRD incidence will be stratified by age group and sex under each of the three definitions of failure of a medication regimen.
Measured: Up to 4 years
Incidence Rate of TRD as Separate Estimates for the Medicaid Population, the Medicare Population, and the Privately Insured Population
TRD incidence will be stratified by data population (database): Medicaid, Medicare, Privately insured.
Measured: Up to 4 years
Secondary outcomes (2)
Incidence on TRD Based on Sensitivity Analysis
Sensitivity analyses are intended to clarify how the results of the present study will compare to the results of other studies that may define as The maximum time for failure of a regimen is changed to: 60, 120, 150, or 365 days, or is not limited; the requirement that a regimen include greater than or equal to (>=) 28 days' supply of the antidepressant medication and antipsychotic medication (if present) is changed to >= 42 days and 14 days supply; participants who get an excluded diagnosis are retroactively excluded from the study cohort; or the definition of an incident case adds a requirement for no depression diagnosis in the prior year.
Measured: Up to 4 years
Number of Participants With Selected Markers for Severity of Depression
The following markers of severity will be tabulated during the PTD episodes and stratified according to whether the participant develops or does not develop TRD during the study period: Electro-convulsive therapy, hospitalization with a diagnosis of depression, receiving a diagnosis of suicidal thoughts, receiving a diagnosis of self-harm, emergency department visit with a diagnosis of injury, emergency department visit with a diagnosis of poisoning.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start15 Jan 2017
- Primary completion18 May 2017
- Study completion18 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, Treatment-ResistantStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- 200,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109002
- Sponsor's protocol ID
- CR108308
- Other IDs
- RRA-18629
- Status last verified
- Apr 2025
- First submitted
- 6 Apr 2017
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data for this study came from health services databases to which access is available under contracts that limit further distribution.
Publications
Fife D, Reps J, Cepeda MS, Stang P, Blacketer M, Singh J. Treatment resistant depression incidence estimates from studies of health insurance databases depend strongly on the details of the operating definition. Heliyon. 2018 Jul 26;4(7):e00707. doi: 10.1016/j.heliyon.2018.e00707. eCollection 2018 Jul.
PubMed 30094377
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Treatment Resistant Depression in the US: Analysis of Health Services Databases
- ClinicalTrials.gov ID
- NCT03109002
- Acronym / sponsor ID
- CR108308
- Conditions
- Depressive Disorder, Treatment-Resistant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200,000 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 18 May 2017 (actual)
- Study completion
- 18 May 2017 (actual)
- First posted
- 11 Apr 2017 (actual)
- 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 purpose of this study is to describe the epidemiology of Treatment Resistant Depression (TRD) in the US, including the population incidence of TRD, and TRD as a proportion of Pharmacologically Treated Depression (PTD), and stratify the estimates by sex and age group, with separate estimates for the Medicaid population, the Medicare population, and the privately insured population. Anonymized participants data will be used for the analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort: Pharmacologically Treated Depression (PTD) Cases | – | –This study is based on anonymized health services data, study population include US residents with medical insurance between 1 Jan, 2010 and 31 Dec, 2014 as described by the Truven MarketScan Medicaid (MDCD), Truven MarketScan Medicare Supplemental (MCDR), and Truven MarketScan Commercial Claims and Encounters (CCAE) databases. Within each database, pharmacologically treated depression (PTD) cases incident during 2011 will be followed for up to 4 years to ascertain their TRD status and 1-year incidence rates for PTD and TRD. Participants will not receive any intervention as a part of this study. To assure they are incident rather than prevalent cases, study participants are required to have 1 year without a dispensing of an antidepressant medication before they can join the cohort. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- US residents with medical insurance between 1 Jan, 2010 and 31 Dec, 2014 will be assessed.
Key inclusion criteria (3 listed)
- Have been in the database for the past year (ignoring breaks of < 30 days)
- Have not had, an excluded diagnosis or dispensing of an AD medication during the past year
- Are aged 14 to 60 years (if in the CCAE or MCDC databases), or are aged greater than or equal to (>=) 65 years (if in the MCDR database). Age is defined as age on Jan 1, 2011. The boundary at age 60 for the first two databases is intended to avoid loss to follow-up due to transfer to Medicare at age 65. The boundary at age 65 for the MCDR database reflects the fact that very few people described by that database are aged less than 65
Key exclusion criteria (1 listed)
- Participants will be excluded when they receive diagnoses Schizophrenia, Bipolar disorder including mania or Dementia
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
Incidence Rate of Treatment Resistant Depression
Time frame: Up to 4 years
TRD will be defined as the failure of two medications, as marked by their replacement or supplementation with other medications using three alternative definitions. In one the time for a medication regimen to fail is limited to less than or equal to (<=) 3 months and in the second the time for a medication regimen to fail is limited to <= 6 months, both corresponding to the medication never providing adequate relief. In the third, the time for a medication regimen to fail will be limited to <= 2 years, corresponding to the medication not providing permanent or very long lasting relief.
Treatment Resistant Depression as a Proportion of Pharmacologically Treated Depression
Time frame: Up to 4 years
An episode of PTD begins when a member of the study cohort receives a dispensing of an antidepressant (AD) medication and receives a diagnosis of depression between 180 days before that dispensing and 30 days after that dispensing.
Incidence Rate of Treatment Resistant Depression by Age Group and Sex
Time frame: Up to 4 years
TRD incidence will be stratified by age group and sex under each of the three definitions of failure of a medication regimen.
Incidence Rate of TRD as Separate Estimates for the Medicaid Population, the Medicare Population, and the Privately Insured Population
Time frame: Up to 4 years
TRD incidence will be stratified by data population (database): Medicaid, Medicare, Privately insured.
2 secondary outcomes
Incidence on TRD Based on Sensitivity Analysis
Time frame: Up to 4 years
Number of Participants With Selected Markers for Severity of Depression
Time frame: Up to 4 years
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 27 Apr 2025.
- Results publication: PubMed 30094377Fife D, Reps J, Cepeda MS, Stang P, Blacketer M, Singh J. Treatment resistant depression incidence estimates from studies of health insurance databases depend strongly on the details of the operating definition. Heliyon. 2018 Jul 26;4(7):e00707. doi: 10.1016/j.heliyon.2018.e00707. eCollection 2018 Jul.
- Individual participant dataSharing planned: No. The data for this study came from health services databases to which access is available under contracts that limit further distribution.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Treatment-Resistant, run by Janssen Research & Development, LLC.
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 3 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 27 Apr 2025. 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?
Incidence Rate of Treatment Resistant Depression (time frame: Up to 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03109002, which also lists 1 linked publication.
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 27 Apr 2025.