N/A N=5 Randomized Quadruple-blind Treatment

Deep Brain Stimulation (DBS) for Treatment-Resistant Depression (TRD)

Treatment Resistant Depression · Depressive Disorder, Treatment-Resistant · Depression, Bipolar

Bottom Line

View on ClinicalTrials.gov: NCT01898429 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Sep 2018

Primary outcome: Primary: Comparison of 12 Weeks of Left Unilateral DBS vs. 12 Weeks Right Unilateral DBS on Change in 17-item Hamilton Depression Rating Scale (HDRS-17) — 22.35; 18.8; 21.4; 17.4 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SCC DBS (Device)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Paul Holtzheimer
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Comparison of 12 Weeks of Left Unilateral DBS vs. 12 Weeks Right Unilateral DBS on Change in 17-item Hamilton Depression Rating Scale (HDRS-17)	22.35; 18.8; 21.4; 17.4	—

Summary

In this pilot study, we propose to test whether high frequency stimulation of the subcallosal cingulate (SCC) is a safe and efficacious antidepressant treatment in five TRD patients, to compare the effects of left-sided vs. right-sided stimulation, and to investigate potential mechanisms of action of this intervention. Importantly, this study will be used to assess the need for and assist in planning a larger, more definitive trial of SCC DBS for TRD.

Eligibility Criteria

A partial list of eligibility criteria includes:

Age 18-70 years old
Ability to provide written informed consent
Current Major Depressive Episode (MDE), secondary to either Major Depressive Disorder or Bipolar Disorder (I, II or NOS)
A current depressive episode of at least 12 months duration
For patients with a bipolar disorder, the last hypomanic or manic episode must have been at least 2 years before study entry
A maximum Global Assessment of Functioning of 50
Able to tolerate general anesthesia, DBS surgery and MRI scans
No significant cerebrovascular risk factors or a previous stroke, documented major head trauma or neurodegenerative disorder
No currently active clinically significant Axis I psychiatric diagnosis or a personality disorder likely to interfere with the study
No evidence of global cognitive impairment
Lives locally or willing to relocate to the area for up to One Year

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01898429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.