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

December 4, 2025 updated by: René Ernst Nielsen, Aalborg University Hospital

Optimising Treatment for Patients With Depressive Episodes in General Practice Through Algorithm-Based Treatment: A Randomised, Open-label Controlled Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

171

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sarah Bloch, MD and PhD student
  • Phone Number: 0045 40196342
  • Email: s.bloch@rn.dk

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Recruiting
        • Aalborg University Hospital, Department of Psychiatry
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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.
Other Names:
  • Treatment as usual by a general practitioner
  • TAU-GP
Other: Treatment 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.
Other Names:
  • Treatment as usual by a psychologist
  • TAU-P
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)
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.
Other Names:
  • Treatment as usual by a general practitioner
  • TAU-GP
Other: Treatment 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.
Other Names:
  • Treatment as usual by a psychologist
  • TAU-P
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
This is an open-label pharmacological intervention.
Other Names:
  • ALGO
  • Algorithm-guided treatment
  • Algorithm treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Hamilton Rating Scale for Depression, 6 item version (HAM-D6)
Time Frame: From enrollment to the end of treatment at 12 weeks.
From enrollment to the end of treatment at 12 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
The Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: From enrollment to the end of treatment at 12 weeks.
From enrollment to the end of treatment at 12 weeks.
The Major Depression Inventory (MDI)
Time Frame: From enrollment to the end of treatment at 12 weeks.
From enrollment to the end of treatment at 12 weeks.
The Personal and Social Performance Scale (PSP)
Time Frame: From enrollment to the end of treatment at 12 weeks
From enrollment to the end of treatment at 12 weeks
The Danish Adult Reading Test (DART)
Time Frame: At enrollment
At enrollment
The Brief INSPIRE-O
Time Frame: At the end of the treatment at 12 weeks.
At the end of the treatment at 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Estimated)

December 4, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20250019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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