Comparing Brain Stimulation and Antidepressant Medication for Early Depression Treatment
Compares magnetic brain stimulation with an antidepressant pill in adults with early major depression.
Plain-language title generated from the registry record
Registry title: Effects of rTMS Compared to SSRI as Early Treatment of Depression (Early-TMS)
Key facts
- Where
- Tübingen, GermanySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06545474, who can take part
Where in Germany
- University Hospital TuebingenTübingen, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital Tuebingen
- Trial code
- NCT06545474
- Record updated
- 10 November 2026
- Original description
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, 106 patients suffering from non-treatment resistant major depression (non-TR MD) will be randomized in Stage I to either 4 weeks bilateral theta burst stimulation (TBS) or 4 weeks antidepressant SSRI medication. The allocation to Stage II occurs therapy response-adapted. Patients receive either a maintenance treatment or a switch to the respective other treatment arm. The primary outcome is the comparison of the two study arms with regard to therapy response measured with the Montgomery-Asberg Depression Rating Scale (MADRS) after 4 weeks at the end of Stage I.Read full original descriptionShow less
Repetitive Transcranial Magnetic Stimulation (rTMS) as an Early Intervention in Major Depression (MD) Compared to Antidepressant Selective Serotonin Reuptake Inhibitor (SSRI) Medication (Early-TMS)
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, 106 patients suffering from non-treatment resistant major depression (non-TR MD) will be randomized in Stage I to either 4 weeks bilateral theta burst stimulation (TBS) or 4 weeks antidepressant SSRI medication. The allocation to Stage II occurs therapy response-adapted. Patients receive either a maintenance treatment or a switch to the respective other treatment arm. The primary outcome is the comparison of the two study arms with regard to therapy response measured with the Montgomery-Asberg Depression Rating Scale (MADRS) after 4 weeks at the end of Stage I.
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: antiepileptic drugs or benzodiazepines in a dosage equivalent to > 1 mg Lorazepam/d; treatment resistance defined as the failure of at least one adequate antidepressant treatment attempt in the current or previous depressive episode; intracranial metallic implants; previous rTMS treatment; comorbid Axis I disorder (except anxiety disorders and ADHD); presence of severe, clinically relevant, and predominant comorbid personality disorder; 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); other severe somatic diseases; pregnancy; acute suicidal ideation (MADRS item 10 score > 4); presence of psychotic symptoms; deep brain stimulation; contraindications for the use of escitalopram.