Early use of rTMS vs an SSRI for non-treatment resistant depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, multicenter phase 2 trial enrolling adults with moderate to severe major depressive disorder who have not previously received antidepressants. In stage I, participants are randomly assigned to 4 weeks of bilateral theta burst stimulation or an SSRI antidepressant. After stage I, therapy response guides stage II, which may continue the same treatment as maintenance, switch to the other treatment, or tailor based on remission and patient preference. The primary outcome compares treatment arms on response status using the MADRS after 4 weeks. The study aims to determine if 4 weeks of bilateral TBS is not inferior to standard SSRI treatment in efficacy and tolerability. Safety and tolerability data will also be collected throughout the trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospital Tuebingen
  Tübingen, Germany Recruiting

Study contacts

• Study coordinator: Christian Plewnia, Prof. Dr.
• Email: christian.plewnia@med.uni-tuebingen.de
• Phone: +4970712984858

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.