Status:
UNKNOWN
PINS Stimulator System for Patients With Treatment Resistant Depression
Lead Sponsor:
Beijing Pins Medical Co., Ltd
Collaborating Sponsors:
Beijing Tiantan Hospital
Conditions:
Treatment-Resistant Depression
Eligibility:
All Genders
20-70 years
Phase:
EARLY_PHASE1
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 inf...
Eligibility Criteria
Inclusion
- 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%
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02253355
Start Date
December 1 2016
End Date
December 1 2018
Last Update
October 14 2016
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