Algorithm-guided treatment versus usual care for treatment-resistant depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 18–65 with unipolar treatment-resistant depression are randomized 1:1 in an open-label, pragmatic design to receive either algorithm-guided treatment (AGT) or treatment as usual (TAU). AGT follows predefined treatment steps, decision points, and if-then rules that use prior treatment history, current symptoms, and tolerability to guide medication sequencing, while TAU leaves choices to the treating clinician. The primary outcome is change in depressive symptoms over 12 weeks measured with the 6-item HAMD, with study visits at baseline, 4, 8, 12 and a 24-week follow-up. After the 12-week randomized phase all participants enter a 12-week extended follow-up during which care is managed at clinician discretion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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 records or a healthcare professional.
2. Have not achieved stable remission of depression in 12 months at investigator's clinical assessment.
3. Severity of depression: A score of at least 21 on the self-reported Major Depression Inventory (MDI).
4. Age criteria: Subjects must be at least 18 years old and below 65 at the time of randomization.
5. Signed document of informed consent.
6. The participant is an outpatient.
7. No significant change in medical treatment in the last 4 weeks before screening visit.
8. The patient is pharmacologically treated for depression.

Exclusion Criteria:

1. A diagnosis of dementia.
2. Substance misuse influencing study participation as judged by the investigator.
3. High risk of non-adherence at the investigator's discretion.
4. Not understanding the Danish language as judged by the investigator.
5. Suicidality according to C-SSRS with a positive response to question 4 or 5 within the last three months or upon investigator's discretion.
6. 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.

Where it's running

• Aalborg University Hospital
  Aalborg, Denmark Recruiting

Study contacts

• Principal investigator: René Ernst Nielsen, Prof., MD, PhD — Aalborg University Hospital, Psychiatry, Denmark
• Study coordinator: Deni Rkman, MD
• Email: deni.rkman@rn.dk
• Phone: +4593856194

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.