PINS Stimulator System for Patients With Treatment Resistant Depression

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.

Study Overview

• Status: Unknown
• Conditions: Treatment-Resistant Depression
• Intervention / Treatment: Device: Deep Brain Stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Deep Brain Stimulation; Stimulation is on	Device: Deep Brain Stimulation; Other Names: PINS Stimulator System
SHAM_COMPARATOR: Placebo; Stimulation is off	Device: Deep Brain Stimulation; Other Names: PINS Stimulator System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in the Hamilton Depression Rating Scale-17	1, 3, 6 and 12 months of stimulation

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence of all adverse events	1, 3, 6 and 12 months of stimulation

Collaborators and Investigators

• Sponsor: Beijing Pins Medical Co., Ltd
• Collaborators: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: September 27, 2014
• First Submitted That Met QC Criteria: September 30, 2014
• First Posted (ESTIMATE): October 1, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): October 14, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
• Other Study ID Numbers: PINS-006