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Compares treatment options for Treatment Resistant Depression (TRD)
Official title Algorithm Guided Treatment Versus Treatment as Usual (TAU) for Patients With Treatment Resistant Depression
ClinicalTrials.gov ID: NCT07080723
What this study is testing
- What it's testing
- The trial utilizes a pragmatic, randomized, open label design with two parallel arms. Participants aged 18-65 with a diagnosis of unipolar depressive disorder and without stable remission in the past 12 months are randomized 1:1 to receive either algorithm guided treatment (AGT) or treatment as usual (TAU).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- A diagnosis of unipolar depressive disorder according to ICD-10 based on documented completion of the Mini International Neuropsychiatric Interview...
- Have not achieved stable remission of depression in 12 months at investigator's clinical assessment.
- Severity of depression: A score of at least 21 on the self-reported Major Depression Inventory (MDI).
- Age criteria: people must be at least 18 years old and below 65 at the time of randomization.
- Signed document of informed consent.
You likely can't join if
- A diagnosis of dementia.
- Substance misuse influencing study participation as judged by the investigator.
- High risk of non-adherence at the investigator's discretion.
- Not understanding the Danish language as judged by the investigator.
- Suicidality according to C-SSRS with a positive response to question 4 or 5 within the last three months or upon investigator's discretion.
- Medical conditions such as cancer, kidney failure, epilepsy, deep brain stimulation device, or other medical conditions interfering with study the...
See the full eligibility criteria
- A diagnosis of unipolar depressive disorder according to ICD-10 based on documented completion of the Mini International Neuropsychiatric Interview, version 7.0.2 (MINI 7.0.2) at Screening and confirmed by medical...
- Have not achieved stable remission of depression in 12 months at investigator's clinical assessment.
- Severity of depression: A score of at least 21 on the self-reported Major Depression Inventory (MDI).
- Age criteria: people must be at least 18 years old and below 65 at the time of randomization.
- Signed document of informed consent.
- The participant is an outpatient.
- No significant change in medical treatment in the last 4 weeks before screening visit.
- The patient is pharmacologically treated for depression.
- A diagnosis of dementia.
- Substance misuse influencing study participation as judged by the investigator.
- High risk of non-adherence at the investigator's discretion.
- Not understanding the Danish language as judged by the investigator.
- Suicidality according to C-SSRS with a positive response to question 4 or 5 within the last three months or upon investigator's discretion.
- Medical conditions such as cancer, kidney failure, epilepsy, deep brain stimulation device, or other medical conditions interfering with study the outcome and safety as judged by investigator's discretion.
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.