Clinical trial NCT06477276: Amygdala TIS for Depression
Official title: A Multicenter, Randomized, Controlled, Double-Blind Trial on the Efficacy and Safety of Amygdala Temporal Interference Stimulation for the Treatment of Depression.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Deep Brain Stimulation
Non-invasive
TI
Amygdala
Temporal Interference
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin Anding Hospital
name: Shanghai East Hospital
First posted: 2024-06-27
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current investigation employs a directed neuromodulation technique, specifically targeting the right amygdala, to ascertain its therapeutic efficacy in managing depressive episodes. The intervention's safety and efficacy will be evaluated using an assessment incorporating depressive symptomatology, cognitive abilities, and daily functions.


Eligibility criteria: Inclusion Criteria:

* Participants must be aged between 18 and 65, with no gender restrictions;
* A diagnosis of depression made by the study physician based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
* HAMD-17 score of 17 or higher;
* Participants must not have changed their antidepressant medication regimen from 30 days prior to signing the informed consent form through the duration of the experiment;
* Eligible individuals or their authorized representatives must demonstrate, as assessed by the study physician, a comprehensive understanding of the study's objectives and procedures, be capable of adhering to the requirements set forth in the study protocol and provide their signature on the informed consent form.

Exclusion Criteria:

* Eligible participants must not have a history of psychiatric disorders such as schizophrenia, as judged by the investigator, which may impact the evaluation of the study's efficacy;
* Participants must not have a history of seizures or prior episodes of epilepsy;
* The presence of metallic foreign objects within the cranial structure or metallic cardiac implants;
* Participants must not have a diagnosis of organic brain disease nor a history of significant cranial trauma or neurosurgical intervention;
* Participants received electroconvulsive therapy or other physical therapies (such as transcranial magnetic stimulation therapy);
* The researcher evaluated the individual's mental state and determined it to present a significant risk of suicidal ideation or behavior;
* Pregnant or breastfeeding;
* Participants who are concurrently engaged in other clinical interventional trials;
* Participants presenting with other circumstances that the investigator deems unsuitable for the intervention being studied.

Primary outcomes:
measure: Hamilton Depression Rating Scale (17-item version)
timeFrame: Baseline, 1 week, 4 weeks and 8 weeks
Secondary outcomes:
measure: Hamilton Depression Rating Scale (6-item version)
timeFrame: treatment completion day
measure: Snaith-Hamilton Pleasure Scale
timeFrame: Baseline, 1 week, 4 weeks and 8 weeks
measure: Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)
timeFrame: Baseline, 1 week, 4 weeks and 8 weeks
measure: Hamilton Anxiety Rating Scale
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, 4 weeks and 8 weeks
measure: 36-Item Short Form Health Survey
timeFrame: Baseline and 8 weeks
measure: World Health Organization Quality of Life Assessment - Brief Version
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Tianjin
country: China
facility: Tianjin Anding Hospital (Mental Health Center of Tianjin Medical University)
Study officials:
affiliation: Ruijin Hospital
name: Yiru Fang, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: