aiTBS for Relieving NSSI in Depressive Patients (NCT05384405) | Clinical Trial Compass
UnknownNot Applicable
aiTBS for Relieving NSSI in Depressive Patients
China60 participantsStarted 2022-07-01
Plain-language summary
Repetitive transcranial magnetic stimulation (rTMS) has been successfully used to help patients with treatment resistant depression. However, its role in alleviating self injuries without suicidal ideation remained uncertain. This trial will compare the effectiveness of active accelerated intermittent theta burst stimulation (aiTBS) rTMS to a placebo control on non-suicidal self injury (NSSI) in patients with unipolar disorder and bipolar disorder.
Who can participate
Age range12 Years – 18 Years
SexALL
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Inclusion criteria
✓. Documentation of DSM-5 criteria for current major depressive disorder (MDD) or bipolar disorder (BD) will be required for study entry.
✓. Ages between 12 and 18 years
✓. At least 1 caregivers to supervise the patient within 3 month.
✓. A score of greater than 17 on the HAM-D17.
✓. Occurrences of self injury behavior consistent with the DSM-5 criteria of NSSI more than 3 times in a month.
✓. Willingness to participate in the study and sign informed consents
Exclusion criteria
✕. Substance abusers such as psychoactive drugs or alcohol.
✕. Severe physical disability and unable to complete follow-up.
✕. Comorbid other major mental illnesses that meet the DSM-5 criteria, such as schizophrenia, mental retardation, dementia, severe cognitive impairment, attention deficit hyperactivity disorder, etc.
✕. Currently in a manic episode, YMRS\>12; rapid-cycling bipolar disorder, bipolar disorder with mixed features.
✕. Suffering from any severe physical disease, neurological disease, traumatic brain injury, etc, that affects the structure or function of the brain in the lifetime.
✕. Unable to read, understand and complete the assessment or to cooperate with the investigators.
What they're measuring
1
Changes in the Deliberate Self-Harm Inventory (DSHI)
Timeframe: Baseline, after 5 treatment days, 2 week and 4 week post-treatment