NCT07080723RecruitingPhase 4
Algorithm Guided Treatment Versus Treatment as Usual (TAU) for Patients With Treatment Resistant Depression
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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). The AGT approach incorporates pre-defined treatment steps, critical decision points, and "if-then" rules based on symptom response. It leverages prior treatment history, current symptomatology, and tolerability profiles to personalize the therapeutic sequence and reduce treatment inertia. In contrast, TAU reflects standard clinical practice, where treatment decisions are left to clinician discretion without algorithmic structure. The primary objective of the study is to determine whether AGT leads to a greater reduction in depressive symptoms over a 12-week treatment period, as measured by the 6-item Hamilton Depression Rating Scale (HAMD-6). Secondary objectives include evaluating cognitive and psychosocial functioning, suicide risk, treatment adherence, tolerability, number of medication changes, and long-term outcomes at a 24-week follow-up, providing insights into the longer-term trajectory of TRD management.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 7 Jul 2025
- Start date
- Aug 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- Aalborg University Hospital
- Diseases
- Depression
- NCT number
- NCT07080723
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 80
- From Aug 2025 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A diagnosis of dementia.
- 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.
Other
- 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.
Who the study is looking for
- 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.
- 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: Subjects 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.