CClinicalTrials.gg
Sign In
RecruitingNCT07263321ODEGAUpdated Dec 10, 2025

Improving Treatment for Depression in General Practice Using a Step-by-Step Care Plan.

An interventional study of Algorithm-Based Treatment and Treatment as usual (TAU) in Depressive Disorder, Depression - Major Depressive Disorder and Depressive Disorder, Major Depressive Disorder, 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 2025-12-10.

Sponsored by Aalborg University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
171
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The goal of this clinical trial is to compare three different treatments for depression in patients with moderate depression in General Practice, aged 18-65 years.

We wish to investigate the effect of the treatment approaches, and 171 patients will be included in the trial. The participants will be randomised to one of the following three treatments:

  1. Standard treatment provided by a general practitioner (i.e. the general practitioner treats the patient as he/she would normally do, when treating a patient with depression).
  2. Standard treatment provided by a psychologist in the form behavioural therapy (i.e. the psychologist treats the patient as he/she would normally do, when treating a patient with depression).
  3. A step-by-step treatment plan carried out by a general practitioner. The plan includes pre-determined follow-ups and a pre-determined, structured plan for which medications to use and when to increase dose or switch medication.

The hypothesis is that a structured and step-by-step treatment approach regarding patients with depression, treated in general practice, is more effective than standard treatment provided by a general practitioner and a psychologist.

All the participants will:

  1. Receive one of the three treatments for 12 weeks.
  2. Have meetings with the project staff every 4 weeks (week 0, 4, 8 and 12) were rating scales will be completed, e.g. a rating scale to measure progress or deterioration in the participant's depression.
02

Conditions studied

  • Depressive Disorder
  • Depression - Major Depressive Disorder
  • Depressive Disorder, Major Depressive Disorder
  • Depressive Disorders
  • Depression
  • Depressive Episodes
  • Depressive Episode

Keywords

  • Treatment for depressive disorder in General Practice
  • Algorithm-based treatment in General Practice
  • Algorithm-guided treatment in General Practice
  • Algorithm-based treatment for depression in General Practice
  • Algorithm-based treatment for depressive disorder in General Practice
  • Algorithm-based treatment for depressive episodes in General Practice
  • Algorithm-guided treatment for depressive episodes in General Practice
  • Optimising treatment for depressive episodes in general practice
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's planned enrollment of 171 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Aalborg University Hospital is the lead sponsor of 195 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The participant must be referred to the study with a diagnosis of unipolar depressive disorder, as judge by the GP.
  2. Severity of the depressive episode corresponding to moderate depression, as judged by the GP.
  3. Clinical uncertainty regarding which of the treatments, medication or psychotherapy, would be the better choice in the case concerned.
  4. Age criteria: Participants must be at least 18 years old and no more than 65 years old at the time of randomisation.
  5. The participant must be a patient in general practice.
  6. Participants must be able to participate in virtual meetings (e.g. by phone or computer) and have e-Boks.
  7. The participant must be willing to receive psychotherapy by a psychologist and/or medication.
  8. Must have signed the document of informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Misuse of substances that might influence the study, as judged by the investigator.
  2. Difficulty in understanding the Danish language, as judged by the investigator.
  3. A diagnosis of dementia.
  4. Medical conditions that might interfere with the study outcome or safety, judged so by the investigator.
  5. Pregnancy.
  6. High risk of non-adherence at the investigator's discretion.
  7. Suicidality: according to C-SSRS with a positive response to question 4 or 5 within the last three months or upon investigator's discretion.
  8. No current medical or psychotherapy treatment initiated within the last 4 weeks prior to screening.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
171 participants (estimated)

Study arms

  • Other
    Treatment as usual by a general practitioner (TAU-GP).

    The participants in this arm will receive "treatment as usual" (TAU), administered by a general practitioner (GP), i.e. the practitioner will implement a standard treatment (e.g. pharmacological) that he or she would normally use when treating a patient with depression in general practice.

    Other: Treatment as usual (TAU)

  • Other
    Treatment as usual by a psychologist (TAU-P).

    The participants in this arm will receive "treatment as usual", meaning a standard treatment in the form of Cognitive Behavioural Therapy (CBT) administered by a psychologist (P).

    Other: Treatment as usual (TAU)

  • Experimental
    Algorithm-based pharmacological treatment by a general practitioner (ALGO).

    In this arm the general practitioner designs a pharmacological, pre-determined and structured step-by-step care plan, including measurement-based care (e.g. Hamilton Rating Scale for Depression), critical decision points and follow ups at week 4, 8 and 12. At these decision points, rating scales are reviewed, and the score results will trigger the next action according to the pre-determined plan.

    Other: Algorithm-Based Treatment

Interventions

  • OtherAlgorithm-Based Treatment

    This is an open-label pharmacological intervention.

    Also known as: ALGO, Algorithm-guided treatment, Algorithm treatment

  • OtherTreatment as usual (TAU)

    This is a "treatment as usual" provided by a general practitioner (GP). The GP will implement a standard treatment he or she normally would use, when treating a patient with moderate depression in general practice.

    Also known as: Treatment as usual by a general practitioner, TAU-GP

  • OtherTreatment as usual (TAU)

    This is a "treatment as usual" provided by a psychologist (P). The psychologist will implement Cognitive Behavioural Therapy as the standard treatment, since this is a widely used and recognised treatment strategy for patients with depression.

    Also known as: Treatment as usual by a psychologist, TAU-P

06

What researchers measure

Primary outcomes

  1. The Hamilton Rating Scale for Depression, 6 item version (HAM-D6)

    Time frame: From enrollment to the end of treatment at 12 weeks.

Secondary outcomes

  1. The Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: From enrollment to the end of treatment at 12 weeks.

  2. The Major Depression Inventory (MDI)

    Time frame: From enrollment to the end of treatment at 12 weeks.

  3. The Personal and Social Performance Scale (PSP)

    Time frame: From enrollment to the end of treatment at 12 weeks

  4. The Danish Adult Reading Test (DART)

    Time frame: At enrollment

  5. The Brief INSPIRE-O

    Time frame: At the end of the treatment at 12 weeks.

07

Study locations

1 of 1 sites recruiting
  • Aalborg University Hospital, Department of Psychiatry
    Aalborg, Denmark
    Recruiting
08

References and documents

Study documents

  • Study protocol · Oct 10, 2025

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07263321
Lead sponsor
Aalborg University Hospital
Responsible party
René Ernst Nielsen (MD, Professor and PhD., Aalborg University Hospital) — Principal investigator
First posted
Dec 4, 2025
Start date
Dec 2025 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Dec 10, 2025

Study contacts

Sarah Bloch, MD and PhD student
Contact
s.bloch@rn.dk
0045 40196342

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions 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.

Other studies in this condition

Depressive Disorder→

Other studies from this sponsor

Aalborg University Hospital

Start the discussion