Phase
Condition
Depression
Treatment
Deep Brain Stimulation(DBS)
Esketamine
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
A psychiatrist-confirmed diagnosis of major depressive disorder in accordance withthe Diagnostic And Statistical Manual Of Mental Disorders.5th Ed (DSM-V);
A psychiatric examination by two trained psychiatrists and a diagnosis consistentwith the DSM-V;
A history of depression of at least 12 months duration in depressed patients (including MECT) who have failed to respond to a full dose and course of treatmentwith 2 or more antidepressants of different mechanisms;
A 17-item score on the HAMD scale ⩾ 20 at initial screening;
A score of ≤ 50 on the Gross Assessment of Functioning (GAF) scale;
The patient himself/herself or legal guardian was able to fully understand thetherapy and agreed to enroll after signing an informed consent form.
Exclusion
Exclusion Criteria:
Persons with severe or unstable cardiac, hepatic, renal, endocrine, hematologic, andother medical disorders and co-morbidities with psychotic symptoms, includingpersonality disorders diagnosed by history, questioning, and clinical examination;
Persons with psychiatric disorders other than depression (except generalizedanxiety);
Persons with a history of substance abuse within 12 months; persons with a previoushistory of epilepsy, and persons with febrile convulsions in childhood;
Patients with a history of suicide attempts within the past 6 months or more than 2suicide attempts within the past 2 years;
Women who are breastfeeding, pregnant, and patients who are pregnant or intend tobecome pregnant during the clinical study;
Contraindications to DBS surgery and MRI;
Years of education less than or equal to 9 years;
Patients who are involuntarily hospitalized.
Study Design
Study Description
Connect with a study center
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou City, Zhejiang 310000
ChinaActive - Recruiting
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