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PINS Stimulator System for Patients With Treatment Resistant Depression

This study is not yet open for participant recruitment.
Verified August 2016 by Beijing Pins Medical Co., Ltd
Sponsor:
ClinicalTrials.gov Identifier:
NCT02253355
First Posted: October 1, 2014
Last Update Posted: October 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Beijing Pins Medical Co., Ltd
  Purpose
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.

Condition Intervention Phase
Treatment-Resistant Depression Device: Deep Brain Stimulation Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PINS Stimulator System for Patients With Treatment Resistant Depression

Further study details as provided by Beijing Pins Medical Co., Ltd:

Primary Outcome Measures:
  • Changes in the Hamilton Depression Rating Scale-17 [ Time Frame: 1, 3, 6 and 12 months of stimulation ]

Secondary Outcome Measures:
  • The incidence of all adverse events [ Time Frame: 1, 3, 6 and 12 months of stimulation ]

Estimated Enrollment: 20
Study Start Date: December 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deep Brain Stimulation
Stimulation is on
Device: Deep Brain Stimulation
Other Name: PINS Stimulator System
Sham Comparator: Placebo
Stimulation is off
Device: Deep Brain Stimulation
Other Name: PINS Stimulator System

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253355


Contacts
Contact: Jia Fumin, PhD +86 010-59361265 pins_medical@163.com

Sponsors and Collaborators
Beijing Pins Medical Co., Ltd
Beijing Tiantan Hospital
Investigators
Study Chair: Li Luming, PhD Tsinghua University
  More Information

Responsible Party: Beijing Pins Medical Co., Ltd
ClinicalTrials.gov Identifier: NCT02253355     History of Changes
Other Study ID Numbers: PINS-006
First Submitted: September 27, 2014
First Posted: October 1, 2014
Last Update Posted: October 14, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders