PINS Stimulator System for Patients With Treatment Resistant Depression

Early Phase 1

• Conditions: Treatment-Resistant Depression
• Interventions: Device: Deep Brain Stimulation

• Registration Number: NCT02253355
• Lead Sponsor: Beijing Pins Medical Co., Ltd

Brief Summary

Evaluate the effects and safety of Deep Brain Stimulation (DBS) to treat on patients with Treatment-Resistant Depression (TRD) and using functional magnetic resonance imaging (fMRI)to evaluate the influence of acupuncture on patients, which will be afford objective evidence for the mechanism of Acupuncture on depression.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-27
• Study First Submitted QC: 2014-09-30
• Study First Posted: 2014-10-01
• Status Verified: 2016-08
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-14
• Study Start: 2016-12
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Subject is aged ages 20-70 years
2. Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by DSM-IV-TR criteria
3. First episode onset before age 45
4. Current episode > 12 months duration
5. In the current episode: Documented resistance (i.e. persistence of the major depressive episode) to a minimum of 4 adequate depression treatments from at least 3 different treatment categories (e.g. SSRI's)
6. SNRI's, TCA's, MAO-inhibitors, Mirtazipine, Nefazodone, Trazodone, Bupropion, lithium augmentation, thyroid augmentation, ECT); Adequacy of treatments as defined by a score of at least 3 according to the amended Antidepressant Treatment History Form (ATHF) criteria
7. Hamilton Depression Rating Scale (HDRS) of > 20 at 3 separate baseline visits, rated by 2 separate psychiatrists, Baseline 2 and Baseline 3 HDRS scores cannot improve ≥ 25%

Exclusion Criteria

1. Patients with hearing impairment
2. Failures of important organs and in severe conditions
3. Be reluctant or disabled to receive neuropsychological assessments;
4. Participate in other clinical trial
5. Has a life expectancy of < 1 year
6. The investigator and/or enrollment review committee, would preclude participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep Brain Stimulation	Deep Brain Stimulation	Stimulation is on
Placebo	Deep Brain Stimulation	Stimulation is off

Primary Outcome Measures

Name	Time	Method
Changes in the Hamilton Depression Rating Scale-17	1, 3, 6 and 12 months of stimulation

Secondary Outcome Measures

Name	Time	Method
The incidence of all adverse events	1, 3, 6 and 12 months of stimulation