Status:
TERMINATED
Remotely Programmed Deep Brain Stimulation of the Bilateral Habenula for Treatment- Resistant Major Depression: An Open Label Pilot Trial
Lead Sponsor:
Ruijin Hospital
Conditions:
Treatment Resistant Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The habenula(Hb) is an epithalamic structure located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing number of st...
Eligibility Criteria
Inclusion
- Age 18-65 years old
- Proficiency in Mandarin language;
- DSM-IV diagnosis of Majior depression disorder;
- Current episode duration ≥ 2 years;
- Failure to respond to a minimum of four different antidepressant treatments;
- Failure or intolerance of an adequate course of electroconvulsive therapy (ECT) during any episode;
- Capacity to provide informed consent (understanding of the study purpose and methods);
Exclusion
- Schizophrenia or history of psychosis unrelated to MDD;
- Antisocial personality disorder, dementia, current tic disorder;
- Past stereotactic neurosurgical intervention;
- Alcohol or substance abuse/dependence within 6 months;
- Neurological disease (Abnormal PET-CT, MRI, EEG);
- Contraindications of MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator;
- Contraindications of stereotactic intervention, e.g. increased bleeding disposition, cerebrovascular diseases;
- Serious and unstable organic diseases (e.g. unstable coronal heart disease);
- HIV positive;
- Pregnancy and/or lactation;
Key Trial Info
Start Date :
July 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2019
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03254017
Start Date
July 24 2017
End Date
August 30 2019
Last Update
November 29 2019
Active Locations (2)
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1
Shanghai Ruijin Hospital Functional Neurosurgery
Shanghai, Shanghai Municipality, China, 200025
2
Shanghai Ruijin Hospital Functional Neurosurgery
Shanghai, Shanghai Municipality, China