Repetitive Transcranial Magnetic Stimulation in Pharmaco-naïve Patients With Major Depression (NAIV)

  • STATUS
    Recruiting
  • End date
    May 1, 2024
  • participants needed
    20
  • sponsor
    University Hospital, Bonn
Updated on 9 June 2022
depression
antidepressants
transcranial magnetic stimulation
major depressive disorder

Summary

Repetitive transcranial magnetic stimulation (rTMS) has become a safe and efficacious treatment for patients with treatment-resistant depression. In several studies investigating the antidepressant efficacy of rTMS, it has been shown that in low treatment-resistant patients rTMS is more efficacious than in patients where several treatment attempts have failed. Albeit this finding, most studies to date primarily recruited patients with relatively high degrees of treatment-resistance and there is a lack of trials investigating rTMS as a first-line treatment. Therefore, this trials aims to compare the antidepressant efficacy of 4 weeks open-label theta-burst TMS in non-treatment-resistant patients with a comparable group of treatment-resistant MDD patients.

Description

Repetitive transcranial magnetic stimulation (rTMS) has become a safe and efficacious treatment for patients with treatment-resistant depression (Mutz et al., 2019). Consequently, several countries including Australia, Brazil, Canada, Israel and the United States have approved rTMS as second-line treatment for major depressive disorder (MDD), while others have included rTMS in their guidelines for good clinical practice (e.g. Finland, Germany and Serbia). Historically, rTMS was conceptualized as a "soft" alternative to electroconvulsive therapy. Therefore, most studies to date primarily recruited patients with relatively high degrees of treatment-resistance (> two failed treatment attempts) and there is a lack of trials investigating rTMS as a first or second line treatment. This finding is contrasted by the fact that on the most stable predictors of response to rTMS is low-treatment resistance.

Therefore, this trial aims to compare the antidepressant efficacy of 20 pharmaco-naïve patients with 20 treatment-resistant patients diagnosed with major depressive disorder. In this open label trial, patients will receive four weeks high-frequency left-sided theta burst TMS (lDLFPC). The target will be located by neuronavigation to the target ascertained by Fox et al.

Details
Condition Major Depressive Disorder
Treatment intermittent theta burst stimulation (iTBS)
Clinical Study IdentifierNCT04000022
SponsorUniversity Hospital, Bonn
Last Modified on9 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant is able to provide consent
Diagnosis of Major Depressive Disorder according to DSM-V criteria
The duration of the current episode is at least four weeks and no more than five years
During the current episode, pharmacological intervention was prescribed (and taken) by the patient

Exclusion Criteria

The participant does not fulfill requirements for iTBS treatment according to safety guidelines
Cardiac or neurological surgery, active implants, metal parts within the body, claustrophobia
Pregnancy or breast-feeding
Psychiatric illness, e.g. substance abuse, psychosis, bipolar disorder, anorexia, obsessive compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, panic disorder, personality disorder
Antipsychotic medication not approved for the treatment of depression
Acute suicidality
Conditions related to increased intracranial pressure
Brain injury or stroke
History of epilepsy in patient or in first-degree relative
Cerebral aneurysm
Neurological illness (e.g. dementia (score of less than 25 in Mini Mental State Exam), Parkinson's disease, chorea huntington, multiple sclerosis)
Course of electroconvulsive therapy (ECT) within the last three months
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