A Phase 4 interventional study of Psychopharmacological treatment and Cognitive-behavioral group treatment (CBGT-D) in Depression - Major Depressive Disorder, sponsored by Goethe University. Not yet recruiting at 3 sites in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Goethe University · Phase 4, Interventional, and Treatment
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Among 268 studies in Depression with a site in Germany — 40 open to participants now, 45 under way, 4 of them phase 3. Depression · Germany.
Among the 268 studies in Depression with a site in Germany, this one is the 128th largest by planned enrollment of the 219 interventional ones that give a count, is one of 9 that started in 2026, is one of 17 in phase 4, reaches primary completion later than 36 of the 44 other live ones, and was the 262nd registered.
8,590 studies on the registry are indexed under Depression; 1,728 are open to participants now.
Browse Depression studies →40 of the 268 studies in Depression with a site in Germany are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in Germany, United States, Australia and 12 more countries
Ages 18–75
University of Regensburg · Sites in Germany
Ages 18–70
Dr. Nils B. Kroemer · Sites in Germany
Ages 18–40 · Healthy volunteers
University Hospital, Essen · Sites in Germany
Ages 18+
Eli Lilly and Company · Sites in Germany, United States, Australia and 12 more countries
Ages 18–75
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 1,090 Depression studies recruiting now, 470 (43%) set no upper age limit and 520 (48%) stop at 75 or younger; 203 take children under 18; 311 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.
268 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 19 · Phase 3 34 · Phase 4 17
First in 1997; this study’s year is marked. 9 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 90 is above the median of 81 across 7,074 interventional studies indexed under Depression.
Median enrollment 120 across the 219 interventional studies, 205 across the 49 observational. Of the 184 that completed or were terminated, 27 (15%) have results posted.
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49 of 268 have an industry lead sponsor. The 10 most frequent:
Goethe University is the lead sponsor of 98 studies on the registry; 15 are open to participants now.
Goethe University has 3 studies filed under Depression — fewer than ten, so there is no comparison to draw.
13 of the studies in Depression with a site in Germany that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07076407Phase 3Xenon Pharmaceuticals Inc.A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3) | 2027-05 |
| NCT06793397Phase 3Cybin IRL LimitedA Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder | 2027-06-07 |
| NCT07159347Ludwig-Maximilians - University of MunichAssessment of Daily Stressors in Children With Depressive Symptoms for the Development of a Gamified Emotion Regulation App | 2026-12 |
| NCT07889739Technical University of MunichSensation Seeking and TMS Response in TRD | 2027-01-31 |
| NCT06831994Universitätsklinikum Hamburg-EppendorfDigital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity | 2027-02-28 |
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Among the 268 studies in Depression with a site in Germany, from their registry updates:
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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.
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Exclusion Criteria:
Participants receive psychopharmacological treatment according to guideline-based clinical practice.
Drug: Psychopharmacological treatment
Participants receive manualized cognitive-behavioral group psychotherapy.
Behavioral: Cognitive-behavioral group treatment (CBGT-D)
Combination of the aforementioned psychopharmacological and cognitive-behavioral group treatment.
Drug: Psychopharmacological treatment · Behavioral: Cognitive-behavioral group treatment (CBGT-D)
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.
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.
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.
Time frame: From Baseline (2 weeks) to immediately Post-Treatment (11 weeks)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Inclusion to immediately Mid-Treatment (7 weeks)
Plan to share: Undecided — Individual participant data that underlie reported results will be shared after deidentification.
Start is estimated for Feb 2026; primary completion for Jan 2028, 23 months later.
Of 110 non-industry phase 4 interventional studies under Depression, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 59. This study's planned 23 months is below that.
Counting every sponsor, half of 119 studies reached it within 32 months; a quarter within 17 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Goethe University