PINS Stimulator System for Patients With Treatment Resistant Depression

NCT ID: NCT02253355

Last Updated: 2016-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-12-31

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.

Conditions

Treatment-Resistant Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Deep Brain Stimulation

Stimulation is on

Group Type: EXPERIMENTAL

Deep Brain Stimulation

Intervention Type: DEVICE

Placebo

Stimulation is off

Group Type: SHAM_COMPARATOR

Deep Brain Stimulation

Intervention Type: DEVICE

Interventions

Deep Brain Stimulation

Intervention Type: DEVICE

Other Intervention Names

PINS Stimulator System

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: collaborator

Beijing Pins Medical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Luming, PhD

Role: STUDY_CHAIR

Tsinghua University

Central Contacts

Jia Fumin, PhD

Role: CONTACT

pins_medical@163.com

+86 010-59361265

Other Identifiers

PINS-006

Identifier Type: -

Identifier Source: org_study_id