Depressive Disorder, Major Clinical Trial
Official title:
Transcranial Magnetic Stimulation: Evaluation of Improvement of Transdiagnostic Psychiatric Symptoms and Changes in Functional Neuroiming in Young Adults Patients With Major Depressive Disorder and Non-suicidal Self-injury
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). The main questions this study aims to answer are: - Does adjunctive TMS reduce psychiatric symptoms in young adults with major depressive disorder and non-suicidal self-injury? - Does adjunctive TMS cause any changes in neuroimaging markers in young adults with major depressive disorder and non-suicidal self-injury? - Does adjunctive TMS cause any effects on blood biomarkers in young adults with major depressive disorder and non-suicidal self-injury? Participants in this study will undergo an extensive clinical evaluation, functional neuroimaging tests (MRI and fNIRS), and peripheral blood collection. They will be randomly assigned to one of two interventions: (1) 20 sessions of TMS using the intermittent theta burst stimulation (iTBS) protocol, or (2) 20 sham sessions using a placebo procedure with the TMS equipment. After the 20 sessions, additional clinical assessments, neuroimaging and blood tests will be conducted. The data analysis will compare the two groups in terms of response and remission of internalizing and externalizing psychiatric symptoms, as well as neuroimaging and blood tests outcomes.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | February 28, 2025 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 29 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto do Cérebro do Rio Grande do Sul | Porto Alegre | RS |
Lead Sponsor | Collaborator |
---|---|
Brain Institute of Rio Grande do Sul |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Depression Rating Scale | Proportion of individuals with a 50% or more score reduction between before and after intervention | Week 1 prior to TMS treatment and week 1 after completion of TMS treatment | |
Primary | Patient Health Questionnaire-9 | Proportion of individuals with a 50% or more score reduction between before and after intervention | Week 1 prior to TMS treatment and week 1 after completion of TMS treatment | |
Primary | Montgomery-Asberg Depression Rating Scale | Proportion of individuals with a 50% or more score reduction between before and after intervention | Week 1 prior to TMS treatment and week 1 after completion of TMS treatment | |
Primary | fMRI assessed neural network connectivity | Change on functional connectivity | Week 1 prior to TMS treatment and week 1 after completion of TMS treatment | |
Primary | fMRI-assessed resting connectivity | Change (e.g. normalization) of baseline network-level deficits. | Week 1 prior to TMS treatment and week 1 after completion of TMS treatment | |
Secondary | Functional Assessment of Self-Mutilation (FASM) | Difference in score between before and after the intervention | Week 1 prior to TMS treatment and week 1 after completion of TMS treatment | |
Secondary | Hamilton Depression Rating Scale | Proportion of individuals with a 50% or more score reduction between before and after intervention | 1, 3 , 6 and 12 months after completion of TMS treatment | |
Secondary | Patient Health Questionnaire-9 | Proportion of individuals with a 50% or more score reduction between before and after intervention | 1, 3 , 6 and 12 months after completion of TMS treatment | |
Secondary | Montgomery-Asberg Depression Rating Scale | Proportion of individuals with a 50% or more score reduction between before and after intervention | 1, 3 , 6 and 12 months after completion of TMS treatment | |
Secondary | fNIRS- assessed changes in blood oxygenation levels in the brain | Changes in blood oxygenation levels in the brain measured by fNIRS (functional near-infrared spectroscopy) to infer neural activity | Week 1 prior to TMS treatment and week 1 after completion of TMS treatment | |
Secondary | Brain-Derived Neurotrophic Factor (BDNF) | Changes in BDNF levels comparing pre- and post-treatment | Week 1 prior to TMS treatment and week 1 after completion of TMS treatment | |
Secondary | Ciliary Neurotrophic Factor (CNTF) | Changes in CNTF levels comparing pre- and post-treatment | Week 1 prior to TMS treatment and week 1 after completion of TMS treatment | |
Secondary | Glial Cell-Derived Neurotrophic Factor (GDNF) | Changes in GDNF levels comparing pre- and post-treatment | Week 1 prior to TMS treatment and week 1 after completion of TMS treatment | |
Secondary | Nerve Growth Factor (NGF) | Changes in GDNF levels comparing pre- and post-treatment | Week 1 prior to TMS treatment and week 1 after completion of TMS treatment |
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