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NCT05716555
Deep Brain Stimulation for Treatment Resistant Depression
Conditions: Depressive Disorder, Major
Sex: All
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 2
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Location: China
Summary
This study will investigate the safety and efficacy of deep brain stimulation (DBS) in lateral habenula (LH) for patients with treatment-resistant depression.
Eligibility Criteria
Inclusion Criteria:Age 18-70, regardless of gender;Diagnostic And Statistical Manual Of Mental Disorders 5th Ed (DSM-V), for Psychiatrists' Examination of Severe Depressive Disorders;Same diagnostic conclusions based on DSM-V made by two independent psychiatrists;A minimum of 24 months of depressive history, over 2 or more adequate antidepressant trials with Hamilton Depression Rating Scale (HAMD) reduction rate ≤20% (including MECT) ;HAMD-17 scores ⩾ 20 at screening;Functional General Assessment Table (GAF) rating ≤50;Able to comply with the operational and administrative requirements of participation in the study, and able to give written informed consent.Exclusion Criteria:Patients with severe or unstable mental, liver, kidney, endocrine, hematological diseases, or those with psychotic co-morbidities, including personality disorders;History of substance abuse in the past 12 months; history of epilepsy, or febrile seizure in childhood;Patients who have attempted suicide within the past 6 months, or have had a secondary suicide attempt within the past 2 years;Women who are breastfeeding, pregnant, or intend to be pregnant during the clinical study;Any surgical contraindications to undergoing deep brain stimulation (DBS);Patients who cannot give full informed consent.
Source: ClinicalTrials.gov (NCT05716555). StuddyBuddy aggregates publicly available trial information.