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New treatment option for Treatment-resistant Depression (TRD)
Official title Personalized DBS Targeting for Treating Depression
ClinicalTrials.gov ID: NCT06784388
What this study is testing
What is Esketamine?
Esketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for treatment-resistant depression (trd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to optimize the target brain areas for deep brain stimulation (DBS) for depression based on personalized brain imaging and stereo-electroencephalography（SEEG), to administer long-term DBS treatment in the target brain areas, to assess the effectiveness and safety of DBS for refractory depression and to validate the method of personalized optimization of DBS targets. The main questions it aims to answer are: 1.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- A psychiatrist-confirmed diagnosis of major depressive disorder in accordance with the Diagnostic And Statistical Manual Of Mental Disorders.5th Ed...
- A psychiatric examination by two trained psychiatrists and a diagnosis consistent with 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...
- A 17-item score on the HAMD scale ⩾ 20 at initial screening;
- A score of ≤ 50 on the Gross Assessment of Functioning (GAF) scale;
You likely can't join if
- Persons with severe or unstable cardiac, hepatic, renal, endocrine, hematologic, and other medical disorders and co-morbidities with psychotic...
- Persons with psychiatric disorders other than depression (except generalized anxiety);
- Persons with a history of substance abuse within 12 months; persons with a previous history of epilepsy, and persons with febrile convulsions in...
- Patients with a history of suicide attempts within the past 6 months or more than 2 suicide attempts within the past 2 years;
- Women who are breastfeeding, pregnant, and patients who are pregnant or intend to become pregnant during the clinical study;
- Contraindications to DBS surgery and MRI;
See the full eligibility criteria
- A psychiatrist-confirmed diagnosis of major depressive disorder in accordance with the Diagnostic And Statistical Manual Of Mental Disorders.5th Ed (DSM-V);
- A psychiatric examination by two trained psychiatrists and a diagnosis consistent with 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 treatment with 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 the therapy and agreed to enroll after signing an informed consent form.
- 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...
- Persons with psychiatric disorders other than depression (except generalized anxiety);
- Persons with a history of substance abuse within 12 months; persons with a previous history of epilepsy, and persons with febrile convulsions in childhood;
- Patients with a history of suicide attempts within the past 6 months or more than 2 suicide attempts within the past 2 years;
- Women who are breastfeeding, pregnant, and patients who are pregnant or intend to become 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.