New treatment option for Depressive Disorder
Official title Improving Treatment for Depression in General Practice Using a Step-by-Step Care Plan.
ClinicalTrials.gov ID: NCT07263321
What this study is testing
- What it's testing
- The goal of this clinical trial is to compare three different treatments for depression in patients with moderate depression in General Practice, aged 18-65 years. We wish to investigate the effect of the treatment approaches, and 171 patients will be included in the trial.
- 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
- The participant must be referred to the study with a diagnosis of unipolar depressive disorder, as judge by the GP.
- Severity of the depressive episode corresponding to moderate depression, as judged by the GP.
- Clinical uncertainty regarding which of the treatments, medication or psychotherapy, would be the better choice in the case concerned.
- Age criteria: Participants must be at least 18 years old and no more than 65 years old at the time of randomisation.
- The participant must be a patient in general practice.
You likely can't join if
- Misuse of substances that might influence the study, as judged by the investigator.
- Difficulty in understanding the Danish language, as judged by the investigator.
- A diagnosis of dementia.
- Medical conditions that might interfere with the study outcome or safety, judged so by the investigator.
- Pregnancy.
- High risk of non-adherence at the investigator's discretion.
See the full eligibility criteria
- The participant must be referred to the study with a diagnosis of unipolar depressive disorder, as judge by the GP.
- Severity of the depressive episode corresponding to moderate depression, as judged by the GP.
- Clinical uncertainty regarding which of the treatments, medication or psychotherapy, would be the better choice in the case concerned.
- Age criteria: Participants must be at least 18 years old and no more than 65 years old at the time of randomisation.
- The participant must be a patient in general practice.
- Participants must be able to participate in virtual meetings (e.g. by phone or computer) and have e-Boks.
- The participant must be willing to receive psychotherapy by a psychologist and/or medication.
- Must have signed the document of informed consent.
- Misuse of substances that might influence the study, as judged by the investigator.
- Difficulty in understanding the Danish language, as judged by the investigator.
- A diagnosis of dementia.
- Medical conditions that might interfere with the study outcome or safety, judged so by the investigator.
- Pregnancy.
- High risk of non-adherence at the investigator's discretion.
- Suicidality: according to C-SSRS with a positive response to question 4 or 5 within the last three months or upon investigator's discretion.
- No current medical or psychotherapy treatment initiated within the last 4 weeks prior to screening.
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.