Effects of rTMS Compared to SSRI as Early Treatment of Depression (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 Criteria: * 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 Criteria: * 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 and ADHD); * 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.