PINS Stimulator System for Patients With Treatment Resistant Depression

Treatment-Resistant Depression Clinical Trial

Official title:

PINS Stimulator System for Patients With Treatment Resistant Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02253355
• Other study ID #: PINS-006
• Status: Not yet recruiting
• Phase: Phase 0
• First received: September 27, 2014
• Last updated: October 13, 2016
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: Beijing Pins Medical Co., Ltd
• Contact: Jia Fumin, PhD
• Phone: +86 010-59361265
• Email: pins_medical[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment-Resistant Depression

Intervention

Device:
• Deep Brain Stimulation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd	Beijing Tiantan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Hamilton Depression Rating Scale-17		1, 3, 6 and 12 months of stimulation	Yes
Secondary	The incidence of all adverse events		1, 3, 6 and 12 months of stimulation	Yes