PINS Stimulator System for Patients With Treatment Resistant Depression

NCT02253355 | Unknown Early Phase 1 DMC

• 1 other identifier: PINS-006
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Changes in the Hamilton Depression Rating Scale-17

  1, 3, 6 and 12 months of stimulation

Secondary Outcomes (1)

• The incidence of all adverse events

  1, 3, 6 and 12 months of stimulation

Study Arms (2)

Deep Brain Stimulation

EXPERIMENTAL

Stimulation is on

Device: Deep Brain Stimulation

Placebo

SHAM COMPARATOR

Stimulation is off

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

Also known as: PINS Stimulator System

Deep Brain Stimulation; Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is aged ages 20-70 years
• Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by DSM-IV-TR criteria
• First episode onset before age 45
• Current episode \> 12 months duration
• 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)
• 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
• 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%

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Pins Medical Co., Ltd: lead
• Beijing Tiantan Hospital: collaborator

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Li Luming, PhD

  Tsinghua University

  STUDY CHAIR

Central Study Contacts

Jia Fumin, PhD

CONTACT

+86 010-59361265; pins_medical@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2014
• First Posted: October 1, 2014
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 14, 2016

Record last verified: 2016-08