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

Algorithm Guided Treatment Versus Treatment as Usual (TAU) for Patients With Treatment Resistant Depression

This test will see if a stepwise, algorithm-guided plan for antidepressant treatment helps adults (18–65) with treatment-resistant unipolar depression reduce symptoms more than usual clinician-directed care over 12 weeks.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Aalborg University Hospital (Academic / other)
• Locations: 1 site (Aalborg)
• Trial ID: NCT07080723 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are outpatients aged 18–65 with ICD-10 unipolar depressive disorder who have not been in stable remission for the past 12 months, are currently receiving pharmacologic treatment, and score at least 21 on the Major Depression Inventory.

Not a fit: Patients with dementia, active substance misuse that affects participation, those judged at high risk of non-adherence, people not on pharmacologic treatment, or those already in stable remission are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could shorten the time to find an effective antidepressant plan and reduce the trial-and-error burden for people with treatment-resistant depression.

How similar studies have performed: Previous trials of algorithm-guided or measurement-based sequencing for depression have shown modest to moderate benefits in some settings, but overall results have been mixed and depend on implementation.

Eligibility criteria

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 this trial is running

Aalborg

• 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

Conditions Treatment Resistant Depression; Algorithm guided treatment; AGT; ALGO; Treatment as usual; TAU; Treatment resistant depression; TRD