Status:
UNKNOWN
Transcranial Magnetic Stimulation in Patients With Depression and Non-suicidal Self-injury
Lead Sponsor:
Brain Institute of Rio Grande do Sul
Conditions:
Depressive Disorder, Major
Self-Injurious Behavior
Eligibility:
All Genders
18-29 years
Phase:
NA
Brief Summary
This clinical trial aims to investigate the effects of Transcranial Magnetic Stimulation (TMS) as an adjunctive treatment for young adult patients with depression and non-suicidal self-injury (NSSI). ...
Detailed Description
This comprehensive clinical trial seeks to explore the potential therapeutic benefits of Transcranial Magnetic Stimulation (TMS) when used as an adjunctive treatment for young adult patients grappling...
Eligibility Criteria
Inclusion
- Current diagnosis of major depressive disorder by the operational criteria of DSM-5 and non-suicidal self-injury behavior, defined by "engagement in and intentionally self-inflicted harm to the surface of one's body, likely resulting in bleeding, bruising, or pain (e.g., cutting, burning, puncturing, hitting, excessive rubbing), with the expectation that the injury will only lead to minor or moderate physical harm (i.e., no suicidal intent)". (at least one episode in the past year);
- Depression severity score ≥17 points (moderate depression criteria) on the 17-item Hamilton Depression Rating Scale (HAM-D-17);
- Currently receiving psychiatric treatment and/or engaged in psychotherapy with a minimum biweekly frequency;
- Consent to voluntary participation in the study, confirmed by signing the Informed Consent Form;
- Expressed willingness to comply with all study procedures, including imaging examinations and blood tests, with availability during the study, and to communicate with the study team regarding adverse events and other clinically important information;
- Commitment to access continuous psychiatric care before and after study completion;
- In good general health, as evidenced by medical history.
Exclusion
- Participants who present pre-established contraindications for undergoing EMT, based on positive responses in the "TMS Adult Safety Screen (TASS)" questionnaire, such as: cochlear implants, brain stimulators (DBS), electrode implants or aneurysm clips, history of previous seizures, use of pacemakers, presence of implantable defibrillators, brain injury (whether vascular, neoplastic, traumatic, infectious, or metabolic);
- Patients who present a moderate to severe suicide risk, as determined by clinical evaluation or requiring psychiatric hospitalization during the recruitment or EMT application period;
- Patients with severe clinical comorbidities or any other reason that impedes self-mobility, preventing attendance at daily EMT sessions;
- Pregnant patients or those of childbearing age who are sexually active without using contraceptive methods.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06110585
Start Date
November 1 2023
End Date
February 28 2025
Last Update
October 31 2023
Active Locations (1)
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1
Instituto do Cérebro do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000