N/A
Completed N=5
Deep Brain Stimulation (DBS) for Treatment-Resistant Depression (TRD)
Depression · Depressive Disorder, Treatment-Resistant · Depression, Bipolar
Source: ClinicalTrials.gov NCT01898429 ↗
Enrolled (actual)
5
Serious AEs
20.0%
Results posted
Sep 2018
Primary outcomePrimary: 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
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.
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 | — |
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
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. Informational only — not medical advice.