Personalized deep brain stimulation for treating depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to optimize deep brain stimulation (DBS) for treatment-resistant depression by using personalized brain imaging and stereo-electroencephalography (SEEG). Participants will undergo a series of assessments, including preoperative evaluations, SEEG implantation, and long-term DBS treatment, to determine the most effective stimulation targets and parameters for each individual. The study will also explore neural biomarkers associated with depression symptoms and assess the efficacy of the personalized DBS strategies over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. A psychiatrist-confirmed diagnosis of major depressive disorder in accordance with the Diagnostic And Statistical Manual Of Mental Disorders.5th Ed (DSM-V);
2. A psychiatric examination by two trained psychiatrists and a diagnosis consistent with the DSM-V;
3. 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 treatment with 2 or more antidepressants of different mechanisms;
4. A 17-item score on the HAMD scale ⩾ 20 at initial screening;
5. A score of ≤ 50 on the Gross Assessment of Functioning (GAF) scale;
6. The patient himself/herself or legal guardian was able to fully understand the therapy and agreed to enroll after signing an informed consent form.

Exclusion Criteria:

1. Persons with severe or unstable cardiac, hepatic, renal, endocrine, hematologic, and other medical disorders and co-morbidities with psychotic symptoms, including personality disorders diagnosed by history, questioning, and clinical examination;
2. Persons with psychiatric disorders other than depression (except generalized anxiety);
3. Persons with a history of substance abuse within 12 months; persons with a previous history of epilepsy, and persons with febrile convulsions in childhood;
4. Patients with a history of suicide attempts within the past 6 months or more than 2 suicide attempts within the past 2 years;
5. Women who are breastfeeding, pregnant, and patients who are pregnant or intend to become pregnant during the clinical study;
6. Contraindications to DBS surgery and MRI;
7. Years of education less than or equal to 9 years;
8. Patients who are involuntarily hospitalized.

Where it's running

• The Second Affiliated Hospital of Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Junming Zhu, Ph.D.
• Email: dr.zhujunming@zju.edu.cn
• Phone: +86 13968055768

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.