Major Depressive DisorderNCT05952713
Comparative Responses to 15 Different Antidepressants in Major Depressive Disorder
An observational study of Major Depressive Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial summary
Achieving results from RCTs with high internal and external validity is a major challenge within psychiatry due to the nature of psychiatric illnesses. The Investigators will conduct a "real world" naturalistic nation-wide population-based longitudinal register linkage study comparing long-term responses to all kinds… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Antidepressant
- How many people
- 73,336 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2022to 1 Jul 2023
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a psychiatric contact (as inpatients or outpatients) in the period from 1995 to 2018 with a first main index diagnosis of a single depressive episode or recurrent depressive disorder (ICD-10 code: F32-F33.9) with an outpatient purchase of an antidepressant after the depression diagnosis (N=73.336).
Who may be able to join
- All patients with a psychiatric contact (as inpatients or outpatients) in the period from 1995 to 2018 with a first main index diagnosis of a single depressive episode or recurrent depressive disorder (ICD-10 code: F32-F33.9) with an outpatient purchase of an antidepressant after the depression diagnosis (N=73.336).
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Responses to 15 Different Antidepressants in Major Depressive Disorder - Results From a Long-term Nation-wide Population-based Study Emulating a Randomized Trial
Achieving results from RCTs with high internal and external validity is a major challenge within psychiatry due to the nature of psychiatric illnesses. The Investigators will conduct a "real world" naturalistic nation-wide population-based longitudinal register linkage study comparing long-term responses to all kinds of antidepressants in patients with major depressive disorder emulating a randomized trial.
- Conditions
- Major Depressive Disorder
- Being tested
- Antidepressant
- 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.
AntidepressantDrug
Also called sertraline, citalopram, fluoxetine, paroxetine, escitalopram, reboxetine, venlafaxine, duloxetine, mirtazapine, vortioxetine, agomelatine, amitriptyline, imipramine
Treatment with an antidepressant according to Danish register data.
| Study group | Role | What they receive |
|---|---|---|
| SSRI | Group 1: Selective serotonin reuptake inhibitors (reference: sertraline)
Comparisons of the following with sertraline:
Citalopram, Fluoxetine, Paroxetine, Escitalopram Receives: Drug: Antidepressant | |
| NARI | Group 2: Noradrenaline reuptake inhibitors (reference: sertraline) Comparisons of the following with sertraline: Reboxetine Receives: Drug: Antidepressant | |
| SNRI | Group 3: Serotonin and noradrenaline reuptake inhibitors (reference: venlafaxine) Comparisons of Duloxetine with venlafaxine Receives: Drug: Antidepressant | |
| ARI | Group 4: Adrenergic receptor inhibitors (reference: Mirtazapine) Comparisons of Mianserin with Mirtazapine Receives: Drug: Antidepressant | |
| Other drugs | Group 5: Other drugs (reference: sertraline) Comparisons of Vortioxetine and Agomelatine with sertraline Receives: Drug: Antidepressant | |
| TCA | Group 6: Tricyclic antidepressants (reference: amitriptyline)
Comparisons of Nortriptyline, Imipramine, Clomipramine and Dosulepin with amitriptyline Receives: Drug: Antidepressant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Response was defined as continuous monotherapy with an antidepressant drug without switch to or add-on of another antidepressant drug, an antipsychotic drug or lithium or hospitalization with a main ICD-10 diagnosis of a single depressive episode or recurrent depressive disorder .
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Oct 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- 73,336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952713
- Sponsor's protocol ID
- MHSCRDenmark_2
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Responses to 15 Different Antidepressants in Major Depressive Disorder - Results From a Long-term Nation-wide Population-based Study Emulating a Randomized Trial
- ClinicalTrials.gov ID
- NCT05952713
- Acronym / sponsor ID
- MHSCRDenmark_2
- Conditions
- Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73,336 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 19 Jul 2023 (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.
Achieving results from RCTs with high internal and external validity is a major challenge within psychiatry due to the nature of psychiatric illnesses. The Investigators will conduct a "real world" naturalistic nation-wide population-based longitudinal register linkage study comparing long-term responses to all kinds of antidepressants in patients with major depressive disorder emulating a randomized trial.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SSRI | – | Drug: AntidepressantGroup 1: Selective serotonin reuptake inhibitors (reference: sertraline) Comparisons of the following with sertraline: Citalopram, Fluoxetine, Paroxetine, Escitalopram |
| NARI | – | Drug: AntidepressantGroup 2: Noradrenaline reuptake inhibitors (reference: sertraline) Comparisons of the following with sertraline: Reboxetine |
| SNRI | – | Drug: AntidepressantGroup 3: Serotonin and noradrenaline reuptake inhibitors (reference: venlafaxine) Comparisons of Duloxetine with venlafaxine |
| ARI | – | Drug: AntidepressantGroup 4: Adrenergic receptor inhibitors (reference: Mirtazapine) Comparisons of Mianserin with Mirtazapine |
| Other drugs | – | Drug: AntidepressantGroup 5: Other drugs (reference: sertraline) Comparisons of Vortioxetine and Agomelatine with sertraline |
| TCA | – | Drug: AntidepressantGroup 6: Tricyclic antidepressants (reference: amitriptyline) Comparisons of Nortriptyline, Imipramine, Clomipramine and Dosulepin with amitriptyline |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a psychiatric contact (as inpatients or outpatients) in the period from 1995 to 2018 with a first main index diagnosis of a single depressive episode or recurrent depressive disorder (ICD-10 code: F32-F33.9) with an outpatient purchase of an antidepressant after the depression diagnosis (N=73.336).
Key inclusion criteria (1 listed)
- All patients with a psychiatric contact (as inpatients or outpatients) in the period from 1995 to 2018 with a first main index diagnosis of a single depressive episode or recurrent depressive disorder (ICD-10 code: F32-F33.9) with an outpatient purchase of an antidepressant after the depression diagnosis (N=73.336).
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntidepressantAlso: sertraline, citalopram, fluoxetine, paroxetine, escitalopram, reboxetine, venlafaxine, duloxetine, mirtazapine, vortioxetine, agomelatine, amitriptyline, imipramineTreatment with an antidepressant according to Danish register data. | Drug | ARI, NARI, Other drugs, SNRI, SSRI, TCA |
Primary outcome
Response
Time frame: 2 years
Response was defined as continuous monotherapy with an antidepressant drug without switch to or add-on of another antidepressant drug, an antipsychotic drug or lithium or hospitalization with a main ICD-10 diagnosis of a single depressive episode or recurrent depressive disorder .
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 18 Aug 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Response (time frame: 2 years). 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 18 Aug 2023.