PINS Stimulator System for Patients With Treatment Resistant Depression

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02253355

Enrollment

Registered

2014-10-01

Start date

2016-12-31

Completion date

2018-12-31

Last updated

2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment-Resistant Depression

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.

Interventions

DEVICEDeep Brain Stimulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Changes in the Hamilton Depression Rating Scale-17	1, 3, 6 and 12 months of stimulation

Secondary

Measure	Time frame
The incidence of all adverse events	1, 3, 6 and 12 months of stimulation

Contacts

Primary ContactJia Fumin, PhD

pins_medical@163.com+86 010-59361265

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026