Status:
NOT_YET_RECRUITING
Effects of rTMS Compared to SSRI as Early Treatment of Depression (Early-TMS)
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
German Center for Mental Health (DZPG; www.dzpg.org)
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The aim of this randomized multicentre phase 2 clinical trial is to compare the effects of rTMS and SSRI medication as early treatment of depression. In this two-stage, therapy response-adapted trial,...
Detailed Description
This is a therapy response-adapted, two-phase, randomized and controlled study. Initially, the study participants will be randomized to two treatment arms (Stage I: 4 weeks TBS vs. SSRI). After comple...
Eligibility Criteria
Inclusion
- male, female, or diverse gender;
- age between 18 and 65 years;
- moderate to severe MD according to the diagnostic criteria of DSM-5;
- MADRS Score ≥ 20 points;
- the duration of the episode must be at least 2 weeks and not exceed a period of 2 years;
- no previous antidepressant treatment; indication for antidepressant medication;
- patients must be capable of giving informed consent.
Exclusion
- acute suicidal ideation (MADRS item 10 score \> 4);
- presence of psychotic symptoms;
- antiepileptic drugs or benzodiazepines in a dosage equivalent to \> 1 mg Lorazepam/d;
- comorbid Axis I disorder (except anxiety disorders);
- presence of severe, clinically relevant, and predominant comorbid personality disorder;
- treatment resistance defined as the failure of at least one adequate antidepressant treatment attempt in the current or previous depressive episode;
- neurological pre-existing conditions such as severe traumatic brain injury, neoplasms, brain surgery, stroke within the last 3 months, neurodegenerative diseases: epilepsy or history of epileptic seizures;
- cardiac pacemaker (not compatible with MRI);
- intracranial metallic implants;
- previous rTMS treatment;
- deep brain stimulation;
- other severe somatic diseases; pregnancy;
- contraindications for the use of escitalopram.
Key Trial Info
Start Date :
September 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06545474
Start Date
September 15 2024
End Date
December 31 2026
Last Update
August 19 2024
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