A Phase 4 interventional study of Algorithm guided treatment (AGT) and Treatment as usual (TAU) in Treatment Resistant Depression (TRD), sponsored by Aalborg University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Aalborg University Hospital · Phase 4, Interventional, and Treatment
Among 10 studies in Depressive Disorder, Treatment-Resistant with a site in Denmark — 4 open to participants now, 5 under way, 1 of them phase 3. Depressive Disorder, Treatment-Resistant · Denmark.
Among the 10 studies in Depressive Disorder, Treatment-Resistant with a site in Denmark, this one is the 5th largest by planned enrollment, is one of 2 that started in 2025, is the only one in phase 4, and was the 10th registered.
448 studies on the registry are indexed under Depressive Disorder, Treatment-Resistant; 147 are open to participants now.
Browse Depressive Disorder, Treatment-Resistant studies →4 of the 10 studies in Depressive Disorder, Treatment-Resistant with a site in Denmark are open now. Recruiting first, the newest first:
Danish Research Centre for Magnetic Resonance · Sites in Denmark
Klaus Martiny · Sites in Denmark
Region of Southern Denmark · Sites in Denmark
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 115 Depressive Disorder, Treatment-Resistant studies recruiting now, 26 (23%) set no upper age limit and 77 (67%) stop at 75 or younger; 1 take children under 18; 14 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 2 started in 2025.
This study's planned enrollment of 80 is above the median of 59 across 372 interventional studies indexed under Depressive Disorder, Treatment-Resistant.
Median enrollment 79 across the 10 interventional studies. Of the 5 that completed or were terminated, 2 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 10 have an industry lead sponsor. The 8 most frequent:
Aalborg University Hospital is the lead sponsor of 198 studies on the registry; 41 are open to participants now.
Aalborg University Hospital has 1 study filed under Depressive Disorder, Treatment-Resistant — fewer than ten, so there is no comparison to draw.
2 of the studies in Depressive Disorder, Treatment-Resistant with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07080723Aalborg University HospitalAlgorithm Guided Treatment Versus Treatment as Usual (TAU) for Patients With Treatment Resistant Depression | 2027-06 |
| NCT05680220Klaus Martiny40 Hz Light Neurostimulation for Patients With Depression (FELIX) | 2027-06-30 |
Among the 10 studies in Depressive Disorder, Treatment-Resistant with a site in Denmark, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
The study period consists of 12 weeks in the randomized phase and 12-week extended follow up period during which all participants are monitored and treated at the clinician's discretion. After baseline, study visits are planned at 4, 8, 12 and 24 weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment choice is defined in the AGT group by predetermined steps and critical decision points. The critical decision point moment is predetermined and marks the patient's outpatient visit. At these timepoint, HAMD score is determined and change from last visit is calculated, and based on this evaluation, specific treatment revisions are made following established "if-then" decision rules. This implies that the subsequent step is determined by the outcome of the assessment. If the patient's condition is assessed satisfactory, one step is selected and if the desired outcome is not achieved, an alternative step is pursued. Treatment choice for each step is based on patients medical history, previous therapy effect, adverse events, evidence based medicine and is selected a priori when patients are randomized by discussion with a senior consultant. AGT consists of which treatments to use at each step, how to implement each treatment and in what order to implement different treatments.
Other: Algorithm guided treatment (AGT)
TAU group treatment is defined and supervised by senior consultants with an experience in a treatment of patients with treatment resistant depression.
Other: Treatment as usual (TAU)
AGTs consist of strategies (which treatments to use), tactics (how to implement each treatment) and treatment steps (in what order to implement the different treatments). Furthermore, AGTs also define critical decision points during the treatment at which the effects of a certain treatment are assessed and based on this assessment recommend specific treatment revisions according to preset "if-then rules." This is most often done by implementing measurement-based care.
TAU includes the standard clinical care for patients with TRD as determined by a senior consultant.
Hamilton Depression Scale, 6 item version (HAMD-6)
The primary outcome measure is the Hamilton Depression Scale, 6 item version (HAMD-6), used as a continuous variable. The primary outcome is the difference in differences (DID) between patients randomized to receive algorithm-guided treatment as compared to treatment as usual, as measured by HAMD-6, based on the mITT population. The 6-item version of the Hamilton Depression Rating Scale ranges from 0 to 22, with higher scores indicating a worse outcome.
Time frame: From baseline to end of study (12 weeks)
HAMD-17
All secondary outcomes are based on the mITT population unless otherwise specified. A Per Protocol (PP) analysis at 12 weeks and at the end of follow-up is performed for all continuous secondary outcomes. Difference-in-difference in HAMD-17. The 17-item version of the Hamilton Depression Rating Scale ranges from 0 to 52, with higher scores indicating a worse outcome.
Time frame: Up to 24 weeks
HAMD-6
Difference-in-difference in HAMD-6 for the PP12 and the PP24 population. The 6-item version of the Hamilton Depression Rating Scale ranges from 0 to 22, with higher scores indicating a worse outcome.
Time frame: Up to 24 weeks
UKU
Difference in difference in UKU adverse events scale
Time frame: Up to 24 weeks
SCIP
Difference-in-difference in Screen for Cognitive Impairment in Psychiatry (SCIP). Values range from 0 to 64+, higher scores indicating a better outcome.
Time frame: Up to 12 weeks
FAST
Difference-in-difference in the Functioning Assessment Short Test (FAST). Values range from 0 to 72, higher scores indicating a worse outcome).
Time frame: Up to 12 weeks
COBRA
Difference in difference in Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA). Values range from 0 to 48, higher scores indicating a worse outcome.
Time frame: Up to 12 weeks
CGI
Difference in difference in the Clinical Global Impression Scale (CGI). Values range from 1 to 7, higher scores indicating a worse outcome.
Time frame: Up to 12 weeks
C-SSRS
Difference in difference in the Columbia-Suicide Severity Rating Scale (C-SSRS). Values range from 1 to 5, higher scores indicating a worse outcome.
Time frame: Up to 12 weeks
Between-groups difference in proportion of responders and remitters in HAMD-6 score
Responders are defined as subjects with a reduction of at least 50 % in their HAMD-6 scores between baseline and the endpoint of interest. Remitters are defined as subjects with HAMD-6 score below 5 at the endpoint of interest. Both are measured at 8 weeks or at a premature endpoint before last-observation-carried-forward (LOCF) and at 12 weeks or at a premature endpoint before LOCF.
Time frame: Week 8 and 12
Between-group differences in reason for all cause treatment discontinuation
Between-group differences in reason for all cause treatment discontinuation (lack of effect, lack of tolerability, lost to follow-up, or other cause)
Time frame: Up to 24 weeks
Between-group differences in time to all cause treatment discontinuation
Between-group differences in time to all cause treatment discontinuation
Time frame: Up to 24 weeks
Between-group differences in number of changes in treatment strategies
Between-group differences in number of changes in treatment strategies
Time frame: Up to 12 weeks
Between-group differences in number of changes in the number of different prescribed medications over the treatment period
Between-group differences in number of changes in the number of different prescribed medications over the treatment period
Time frame: Up to 12 weeks
Between-group difference for the ITT population in reasons for premature discontinuation
Between-group difference for the ITT population in reasons for premature discontinuation
Time frame: Up to 24 weeks
Between-group difference for the ITT population in reasons for time to all cause discontinuation
Between-group difference for the ITT population in reasons for time to all cause discontinuation
Time frame: Up to 24 weeks
Between-group difference for the ITT population in adverse events and serious adverse events
Between-group difference for the ITT population in adverse events and serious adverse events
Time frame: Up to 12 weeks
Between-groups difference from original randomization in proportion of responders and remitters at end of follow-up
Between-groups difference from original randomization in proportion of responders and remitters at end of follow-up
Time frame: Up to 24 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Jun 2027, 22 months after the start.
Of 18 phase 4 interventional studies under Depressive Disorder, Treatment-Resistant, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 59. This study's planned 22 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Depressive Disorder, Treatment-Resistant →