Efficacy and Safety of DBS in Patients With Treatment-Resistant Depression

Treatment Resistant Depressive Disorder Clinical Trial

Official title:

Efficacy and Safety of MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation in Patients With Treatment-Resistant Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03667872
• Other study ID #: PINS-029
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: June 18, 2022

Study information

• Verified date: December 2018
• Source: Beijing Pins Medical Co., Ltd
• Contact: Zhiyan Wang
• Phone: 010-60736388
• Email: wzyann[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The habenula (Hb) is an ancient structure, located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing number of studies indicated that the lateral habeluna (LHb) is overactivity during depressive behaviors in rats, where it could drive the changes in midbrain monoamine neurotransmitter linked to depression. However, the efficiency and mechanism of deep brain stimulation (DBS) of the LHb and/or its major afferent bundle (i.e., stria medullaris thalami) could treat treatment-resistant major depression (TRD) is still unclear. This research will investigate the effectiveness and mechanism of bilateral MRI Compatible and Long-term LFP Recordable DBS to habenula and/or its major afferent bundle for treatment TRD patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6
• Est. completion date: June 18, 2022
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70 years old;

• DSM-IV diagnosis of Major depression disorder of psychiatrists;

• More than 3 year's history of depression and failure to respond to a minimum of three different antidepressant treatments;

• Failure or intolerance or unwilling of an adequate course of electroconvulsive therapy (ECT) during any episode;

• HAMD-17=20;

• GAF=50;

• Capacity to provide informed consent (understanding of the study purpose and methods);

Exclusion Criteria:

• Obvious medical and psychiatric comorbidities;

• Alcohol or substance abuse/dependence within 12 months;

• Antisocial personality disorder, dementia, current tic disorder;

• Subject has a history of 2 or more suicide attempts < 12 months prior to the screening testing;

• Pregnancy and/or lactation;

• There are contraindications for DBS surgery and chronic stimulation.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depressive Disorder

Intervention

Procedure:
• Bilateral implantation of DBS system to Habeluna
Bilateral implantation of MRI compatible and LFP recordable DBS system to Habeluna

Locations

Country	Name	City	State
China	Habenula DBS	Shenzhen	Shenzhen

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Hamilton Anxiety Scale	Change in the Hamilton Anxiety Scale after the DBS on	Baseline(preoperative),3 months, 6 months, 12months