Depression - Major Depressive DisorderPhase 4DYNDETNCT07488910
Dynamic Networks in Depression Treatment: Mechanisms of Change in Pharmacological, Psychological and Combined Treatment of Depression
A Phase 4 study testing Psychopharmacological treatment and Cognitive-behavioral group treatment (CBGT-D) in people with Depression - Major Depressive Disorder, run by Goethe University at 3 sites in Germany.
Trial summary
This study investigates how antidepressant pharmacotherapy, cognitive-behavioral therapy, or their combination modulate the temporal dynamics and connectivity of depressive symptom networks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Psychopharmacological treatment and Cognitive-behavioral group treatment (CBGT-D)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesGermany
- Study dates
- Feb 2026to Jan 2028
- Phase
- Phase 4
- 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
- Depressive disorder (mild to moderate symptom severity)
- 18-65 years
- must own a smartphone with internet access
Who cannot join
- severe depressive episode
- acute suicidality,
- bipolar disorder,
- substance use disorder
- psychotic depression
- severe medical or neurological illness
Show all 9Show fewer
- insufficient german language skills
- concurrent psychotherapeutic treatment
- conditions that may interfere with fMRI
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites
Clinical Psychology and Psychotherapy
Frankfurt, 60486
Ulrich Stangier, Prof. Dr., +496979823842, stangier@psych.uni-frankfurt.de
Mareike Ebert, M.Sc., m.ebert@psych.uni-frankfurt.de
Department of Psychiatry, Psychosomatics and Psychotherapy
Frankfurt, 60528
Oliver Grimm, PD Dr., +6906963012224, O.Grimm@med.uni-frankfurt.de
Department of Psychiatry and Psychotherapy
Marburg, 35039
Igor Nenadić, Prof. Dr., +4964215865002, nenadic@uni-marburg.de
About this study
Official title: Veränderungen Dynamischer Symptom-Netzwerke Unter Pharmakologischer, Psychotherapeutischer Und Kombinierter Behandlung Bei Depression (DYNDET)
This study investigates how antidepressant pharmacotherapy, cognitive-behavioral therapy, or their combination modulate the temporal dynamics and connectivity of depressive symptom networks. Using intensive longitudinal ecological momentary assessment data, the trial examines treatment-specific changes in symptom interactions.
By applying network-based analytic approaches, the study aims to elucidate differential and potentially complementary mechanisms of change across treatment modalities. Findings may contribute to more informed and individualized treatment strategies for major depressive disorder.
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- Psychopharmacological treatment, Cognitive-behavioral group treatment (CBGT-D)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychopharmacological treatmentDrug
Participants will receive outpatient treatment with escitalopram. Treatment will be initiated at 5 mg/day for three days and increased to a target dose of 10 mg/day. Clinical re-evaluations will take place after two and four weeks. In case of insufficient clinical response, the dose may be increased to 15 mg/day in accordance with guideline recommendations.
Cognitive-behavioral group treatment (CBGT-D)Behavioural
Consisting of a group treatment of the same time frame as the psychopharmacological treatment and includes the following components: psychoeducation, behavioral activation, cognitive restructuring, social problem-solving, homework assignments and relapse prevention.
| Study group | Role | What they receive |
|---|---|---|
| Psychopharmacological treatment | Experimental | Participants receive psychopharmacological treatment according to guideline-based clinical practice. Receives: Drug: Psychopharmacological treatment |
| Psychotherapeutical group treatment | Experimental | Participants receive manualized cognitive-behavioral group psychotherapy. Receives: Behavioral: Cognitive-behavioral group treatment (CBGT-D) |
| Combined intervention | Experimental | Combination of the aforementioned psychopharmacological and cognitive-behavioral group treatment. Receives: Drug: Psychopharmacological treatment; Behavioral: Cognitive-behavioral group treatment (CBGT-D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structure of symptom networks via multilevel vector autoregressive modeling (mlVAR)
Planned network intervention analyses will focus on intervention-specific effects at the symptom-network level. We will describe whether each of the three interventions shows differential direct associations with specific depressive symptoms or processes, operationalized as edges between intervention indicators and symptom/process nodes. We will also examine whether the interventions differ in their pattern of indirect associations within the network, that is, whether changes in some symptoms appear to be associated with downstream changes in other symptoms or processes. In addition, we will compare centrality metrics of depressive symptoms across interventions and over time.
Measured: From Baseline (2 weeks) to immediately Post-Treatment (11 weeks)
Secondary outcomes (10)
Hamilton rating scale for depression (HAM-D)
Observer rated scale of depression severity. Total score ranging from 0 to 51, with lower scores indicating less severity of depressive symptoms.
Measured: From Inclusion to immediately Post-Treatment (11 weeks)
Montgomery-Åsberg Depression Rating Scale (MADRS)
Observer rated scale of depression severity. Total score ranging from 0 to 60, with lower scores representing less severity of depressive symptoms.
Measured: From Inclusion to immediately Post-Treatment (11 weeks)
The Inventory of Depressive Symptomatology clinician (IDS-C)
Observer rated scale of depression severity. Total score ranging from 0 to 84, with lower scores indicating less severity of depressive symptoms.
Measured: From Inclusion to immediately Post-Treatment (11 weeks)
Social and Occupational Functioning Assessment Scale (SOFAS)
Observer rated scale of social and functional impairment. Scores ranging from 0 to 100, with higher scores representing a higher level of functioning.
Measured: Immediately at Inclusion
Positive and Negative Affect Schedule - Short Form (PANAS-SF)
Self report scale of positive and negative affect. Scores can range from 10 to 50 for both subscales (positive affect and negative affect). Higher scores indicate a higher level of either positive or negative affect
Measured: From Inclusion to immediately Mid-Treatment (7 weeks)
Perseverative Thinking Questionnaire (PTQ)
Self-rating scale for repetitive negative thinking. The score ranges from 0 to 60. Higher scores indicate a higher level of repetitive negative thinking
Measured: From Inclusion to immediately Mid-Treatment (7 weeks)
The Acceptance and Action Questionnaire (AAQ-2)
Self-rated measure of psychological flexibility. Score ranging from 7 to 49. Higher total scores indicate less flexibility, while lower total scores indicate more flexibility.
Measured: From Inclusion to immediately Mid-Treatment (7 weeks)
Fragebogen zur sozialen Unterstützung (F-SozU)
Self-report scale of social support. A higher score indicates a better outcome.
Measured: From Inclusion to immediately Mid-Treatment (7 weeks)
Couples Satisafction Index (CSI-4)
Self-report scale of relationship satisfaction in couples with a score range from 0 to 21. Higher scores are associated with higher levels of relationship satisfaction.
Measured: From Inclusion to immediately Mid-Treatment (7 weeks)
Perceived Deficits Questionnaire - Depression (PDQ-D)
Self-rating scale of cognitive dysfunction. Score ranging from 0 to 80. Higher scores representing higher cognitive dysfunction.
Measured: From Inclusion to immediately Mid-Treatment (7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study startFeb 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study employs a parallel-group design with three arms: selective serotonin reuptake inhibitor (SSRI) pharmacotherapy, cognitive behavioral therapy (CBT) delivered in a group format, and a combination of both interventions. The study is multicentred across two locations encompassing three study centres.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Collaborators
- Johann Wolfgang Goethe University Hospital, Philipps University Marburg
- Responsible party
- Principal investigator, Prof. Dr. Ulrich Stangier, Goethe University
- Investigators
- Igor Nenadic, Prof. Dr., Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488910
- Sponsor's protocol ID
- 2025-2718
- Acronym
- DYNDET
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data that underlie reported results will be shared after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veränderungen Dynamischer Symptom-Netzwerke Unter Pharmakologischer, Psychotherapeutischer Und Kombinierter Behandlung Bei Depression (DYNDET)
- ClinicalTrials.gov ID
- NCT07488910
- Acronym / sponsor ID
- DYNDET / 2025-2718
- Conditions
- Depression - Major Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Collaborators
- Johann Wolfgang Goethe University Hospital, Philipps University Marburg
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 23 Mar 2026 (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.
This study investigates how antidepressant pharmacotherapy, cognitive-behavioral therapy, or their combination modulate the temporal dynamics and connectivity of depressive symptom networks. Using intensive longitudinal ecological momentary assessment data, the trial examines treatment-specific changes in symptom interactions.
By applying network-based analytic approaches, the study aims to elucidate differential and potentially complementary mechanisms of change across treatment modalities. Findings may contribute to more informed and individualized treatment strategies for major depressive disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The study employs a parallel-group design with three arms: selective serotonin reuptake inhibitor (SSRI) pharmacotherapy, cognitive behavioral therapy (CBT) delivered in a group format, and a combination of both interventions. The study is multicentred across two locations encompassing three study centres.
| Arm | Type | Receives |
|---|---|---|
| Psychopharmacological treatment | Experimental | Drug: Psychopharmacological treatmentParticipants receive psychopharmacological treatment according to guideline-based clinical practice. |
| Psychotherapeutical group treatment | Experimental | Behavioral: Cognitive-behavioral group treatment (CBGT-D)Participants receive manualized cognitive-behavioral group psychotherapy. |
| Combined intervention | Experimental | Drug: Psychopharmacological treatment, Behavioral: Cognitive-behavioral group treatment (CBGT-D)Combination of the aforementioned psychopharmacological and cognitive-behavioral group treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Depressive disorder (mild to moderate symptom severity)
- 18-65 years
- must own a smartphone with internet access
Key exclusion criteria (9 listed)
- severe depressive episode
- acute suicidality,
- bipolar disorder,
- substance use disorder
- psychotic depression
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 |
|---|---|---|
| Psychopharmacological treatmentParticipants will receive outpatient treatment with escitalopram. Treatment will be initiated at 5 mg/day for three days and increased to a target dose of 10 mg/day. Clinical re-evaluations will take place after two and four weeks. In case of insufficient clinical response, the dose may be increased to 15 mg/day in accordance with guideline recommendations. | Drug | Combined intervention, Psychopharmacological treatment |
| Cognitive-behavioral group treatment (CBGT-D)Consisting of a group treatment of the same time frame as the psychopharmacological treatment and includes the following components: psychoeducation, behavioral activation, cognitive restructuring, social problem-solving, homework assignments and relapse prevention. | Behavioural | Combined intervention, Psychotherapeutical group treatment |
Primary outcome
Structure of symptom networks via multilevel vector autoregressive modeling (mlVAR)
Time frame: From Baseline (2 weeks) to immediately Post-Treatment (11 weeks)
Planned network intervention analyses will focus on intervention-specific effects at the symptom-network level. We will describe whether each of the three interventions shows differential direct associations with specific depressive symptoms or processes, operationalized as edges between intervention indicators and symptom/process nodes. We will also examine whether the interventions differ in their pattern of indirect associations within the network, that is, whether changes in some symptoms appear to be associated with downstream changes in other symptoms or processes. In addition, we will compare centrality metrics of depressive symptoms across interventions and over time.
10 secondary outcomes
Hamilton rating scale for depression (HAM-D)
Time frame: From Inclusion to immediately Post-Treatment (11 weeks)
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: From Inclusion to immediately Post-Treatment (11 weeks)
The Inventory of Depressive Symptomatology clinician (IDS-C)
Time frame: From Inclusion to immediately Post-Treatment (11 weeks)
Social and Occupational Functioning Assessment Scale (SOFAS)
Time frame: Immediately at Inclusion
Positive and Negative Affect Schedule - Short Form (PANAS-SF)
Time frame: From Inclusion to immediately Mid-Treatment (7 weeks)
Perseverative Thinking Questionnaire (PTQ)
Time frame: From Inclusion to immediately Mid-Treatment (7 weeks)
The Acceptance and Action Questionnaire (AAQ-2)
Time frame: From Inclusion to immediately Mid-Treatment (7 weeks)
Fragebogen zur sozialen Unterstützung (F-SozU)
Time frame: From Inclusion to immediately Mid-Treatment (7 weeks)
Couples Satisafction Index (CSI-4)
Time frame: From Inclusion to immediately Mid-Treatment (7 weeks)
Perceived Deficits Questionnaire - Depression (PDQ-D)
Time frame: From Inclusion to immediately Mid-Treatment (7 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 23 Mar 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data that underlie reported results will be shared after deidentification.
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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.
Department of Psychiatry, Psychosomatics and Psychotherapy
Frankfurt, Germany
Igor Nenadic, Prof. Dr. principal investigator
Philipps University Marburg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Psychopharmacological treatment and Cognitive-behavioral group treatment (CBGT-D) in people with Depression - Major Depressive Disorder, run by Goethe University at 3 sites in Germany.
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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structure of symptom networks via multilevel vector autoregressive modeling (mlVAR) (time frame: From Baseline (2 weeks) to immediately Post-Treatment (11 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 23 Mar 2026.