Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: testing SSRI treatment for Major Depressive Disorder

The aim of this randomly assigned 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 randomly assigned in Stage I to either 4 weeks bilateral theta burst stimulation (TBS) or 4 weeks antidepressant SSRI medication.

Official registry: https://clinicaltrials.gov/study/NCT06545474 · University Hospital Tuebingen · enrollment listed as 106

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are bilateral theta burst stimulation, or SSRI treatment. The registry lists allocation as randomized. The aim of this randomly assigned multicentre phase 2 clinical trial is to compare the effects of rTMS and SSRI medication as early treatment of depression.

They plan to enroll about 106 people at Tübingen. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.

Official title (unrewritten)

Repetitive Transcranial Magnetic Stimulation (rTMS) as an Early Intervention in Major Depression (MD) Compared to Antidepressant Selective Serotonin Reuptake Inhibitor (SSRI) Medication (Early-TMS)

Interventions: bilateral theta burst stimulation, SSRI treatment

Primary outcome (registry wording): response rates after Stage I

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • 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;

Public study contact (from the registry)

Christian Plewnia, Prof. Dr.

+4970712984858

christian.plewnia@med.uni-tuebingen.de

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Related recruiting trials in this snapshot

RecruitingPhase 1 / Phase 2Boston, Massachusetts
Phase 1 / Phase 2: testing [F-18]PBR06 for Multiple Sclerosis

The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.

NCT02649985 · Official ClinicalTrials.gov record · Brigham and Women's Hospital

FAQ about this NCT record

Is NCT06545474 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06545474?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06545474?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary