NCT06545474Not yet recruiting
Effects of rTMS Compared to SSRI as Early Treatment of Depression (Early-TMS)
Repetitive Transcranial Magnetic Stimulation (rTMS) as an Early Intervention in Major Depression (MD) Compared to Antidepressant Selective Serotonin Reuptake Inhibitor (SSRI) Medication (Early-TMS)
Source: ClinicalTrials.gov · Last updated 19 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 106 (estimated)
- First submitted
- 5 Aug 2024
- Start date
- Sept 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- University Hospital Tuebingen
- Diseases
- Depression
- NCT number
- NCT06545474
What you commit to
- Study type: Interventional
- Planned participants: 106
- From Sept 2024 to the primary completion date, Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- comorbid Axis I disorder (except anxiety disorders);
- 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;
Other
- acute suicidal ideation (MADRS item 10 score \> 4);
- presence of psychotic symptoms;
- deep brain stimulation;
- contraindications for the use of escitalopram.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.