Comparing a Step-by-Step Treatment Guide With Usual Care for Treatment Resistant Depression
Compares a guided treatment plan with usual care in adults with treatment resistant depression.
Plain-language title generated from the registry record
Registry title: Algorithm Guided Treatment Versus Treatment as Usual (TAU) for Patients With Treatment Resistant Depression
Key facts
- Where
- Aalborg, DenmarkSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07080723, who can take part
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aalborg University Hospital
- Trial code
- NCT07080723
- Record updated
- 27 April 2026
- Original description
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.Read full original descriptionShow less
Algorithm Guided Treatment Versus Treatment as Usual (TAU) for Patients With Treatment Resistant Depression
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.
Inclusion: 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.
Exclusion: 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; 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.