Depressive DisorderODEGANCT07263321
Improving Treatment for Depression in General Practice Using a Step-by-Step Care Plan.
A study testing Algorithm-Based Treatment and Treatment as usual (TAU) in people with Depressive Disorder and Depression - Major Depressive Disorder, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Depression - Major Depressive Disorder, Depressive Disorder, Major Depressive Disorder
- What is being tested?
- Algorithm-Based Treatment and Treatment as usual (TAU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant must be referred to the study with a diagnosis of unipolar depressive disorder, as judge by the GP.
- Severity of the depressive episode corresponding to moderate depression, as judged by the GP.
- Clinical uncertainty regarding which of the treatments, medication or psychotherapy, would be the better choice in the case concerned.
- Age criteria: Participants must be at least 18 years old and no more than 65 years old at the time of randomisation.
- The participant must be a patient in general practice.
- Participants must be able to participate in virtual meetings (e.g. by phone or computer) and have e-Boks.
- The participant must be willing to receive psychotherapy by a psychologist and/or medication.
- Must have signed the document of informed consent.
Who cannot join
- Misuse of substances that might influence the study, as judged by the investigator.
- Difficulty in understanding the Danish language, as judged by the investigator.
- A diagnosis of dementia.
- Medical conditions that might interfere with the study outcome or safety, judged so by the investigator.
- Pregnancy.
- High risk of non-adherence at the investigator's discretion.
- Suicidality: according to C-SSRS with a positive response to question 4 or 5 within the last three months or upon investigator's discretion.
- No current medical or psychotherapy treatment initiated within the last 4 weeks prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University Hospital, Department of Psychiatry
Aalborg
Sarah Bloch, 0045 40196342, s.bloch@rn.dk
About this study
Official title: 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:
Read more
- 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).
- 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).
- 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:
- Receive one of the three treatments for 12 weeks.
- 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.
- Conditions
- Depressive Disorder, Depression - Major Depressive Disorder, Depressive Disorder, Major Depressive Disorder, Depressive Disorders, Depression, Depressive Episodes
- Being tested
- Algorithm-Based Treatment, Treatment as usual (TAU)
- 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
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algorithm-Based TreatmentOther
Also called ALGO, Algorithm-guided treatment, Algorithm treatment
This is an open-label pharmacological intervention.
Also called Treatment as usual by a general practitioner, TAU-GP
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 called Treatment as usual by a psychologist, TAU-P
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual by a general practitioner (TAU-GP). | Other | 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. Receives: Other: Treatment as usual (TAU) |
| Treatment as usual by a psychologist (TAU-P). | Other | 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). Receives: Other: Treatment as usual (TAU) |
| Algorithm-based pharmacological treatment by a general practitioner (ALGO). | Experimental | 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. Receives: Other: Algorithm-Based Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Hamilton Rating Scale for Depression, 6 item version (HAM-D6)
Measured: From enrollment to the end of treatment at 12 weeks.
Secondary outcomes (5)
The Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: From enrollment to the end of treatment at 12 weeks.
The Major Depression Inventory (MDI)
Measured: From enrollment to the end of treatment at 12 weeks.
The Personal and Social Performance Scale (PSP)
Measured: From enrollment to the end of treatment at 12 weeks
The Danish Adult Reading Test (DART)
Measured: At enrollment
The Brief INSPIRE-O
Measured: At the end of the treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, René Ernst Nielsen, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263321
- Sponsor's protocol ID
- N-20250019
- Acronym
- ODEGA
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Treatment for Patients With Depressive Episodes in General Practice Through Algorithm-Based Treatment: A Randomised, Open-label Controlled Trial.
- ClinicalTrials.gov ID
- NCT07263321
- Acronym / sponsor ID
- ODEGA / N-20250019
- Conditions
- Depressive Disorder, Depression - Major Depressive Disorder, Depressive Disorder, Major Depressive Disorder, Depressive Disorders, Depression, Depressive Episodes
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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).
- 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:
- Receive one of the three treatments for 12 weeks.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual by a general practitioner (TAU-GP). | Other | Other: Treatment as usual (TAU)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. |
| Treatment as usual by a psychologist (TAU-P). | Other | Other: Treatment as usual (TAU)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). |
| Algorithm-based pharmacological treatment by a general practitioner (ALGO). | Experimental | Other: Algorithm-Based TreatmentIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The participant must be referred to the study with a diagnosis of unipolar depressive disorder, as judge by the GP.
- Severity of the depressive episode corresponding to moderate depression, as judged by the GP.
- Clinical uncertainty regarding which of the treatments, medication or psychotherapy, would be the better choice in the case concerned.
- Age criteria: Participants must be at least 18 years old and no more than 65 years old at the time of randomisation.
- The participant must be a patient in general practice.
Key exclusion criteria (8 listed)
- Misuse of substances that might influence the study, as judged by the investigator.
- Difficulty in understanding the Danish language, as judged by the investigator.
- A diagnosis of dementia.
- Medical conditions that might interfere with the study outcome or safety, judged so by the investigator.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algorithm-Based TreatmentAlso: ALGO, Algorithm-guided treatment, Algorithm treatmentThis is an open-label pharmacological intervention. | Other | Algorithm-based pharmacological treatment by a general practitioner (ALGO). |
| Treatment as usual (TAU)Also: Treatment as usual by a general practitioner, TAU-GPThis 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 | Treatment as usual by a general practitioner (TAU-GP). |
| Treatment as usual (TAU)Also: Treatment as usual by a psychologist, TAU-PThis 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 | Treatment as usual by a psychologist (TAU-P). |
Primary outcome
The Hamilton Rating Scale for Depression, 6 item version (HAM-D6)
Time frame: From enrollment to the end of treatment at 12 weeks.
5 secondary outcomes
The Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 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.
The Personal and Social Performance Scale (PSP)
Time frame: From enrollment to the end of treatment at 12 weeks
The Danish Adult Reading Test (DART)
Time frame: At enrollment
The Brief INSPIRE-O
Time frame: At the end of the treatment at 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithm-Based Treatment and Treatment as usual (TAU) in people with Depressive Disorder and Depression - Major Depressive Disorder, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Bloch, MD and PhD student (0045 40196342, s.bloch@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Hamilton Rating Scale for Depression, 6 item version (HAM-D6) (time frame: From enrollment to the end of treatment at 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.