Not currently recruiting at University of California Health

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

a study on Depression

Summary

Eligibility
for people ages 22-70 (full criteria)
Location
at UC Davis UCLA
Dates
study started
completion around
Principal Investigator
by Andrew Leuchter, MD (ucla)David Brandman, MD (ucdavis)

Description

Summary

The goal of this clinical trial is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using Deep Brain Stimulation (DBS) as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) in adults.

Official Title

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS

Details

The aim of this prospective, multi-centered, double-blind, randomized, delayed-stimulation/ Sham-stimulation controlled 12-month study is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using the Infinity™ Deep Brain Stimulation (DBS) system as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) for adults who are experiencing a Major Depressive Episode (MDE) with inadequate response to 4 or more antidepressant treatments.

In a double-blind fashion, half the subjects will receive active DBS therapy, while half will receive sham stimulation. After the 12-month endpoint, all subjects will be unblinded to their treatment group, and subjects in the control arm will receive active DBS therapy.

Keywords

Treatment Resistant Depression, DBS, Major Depressive Disorder, Bilateral Stimulation, Antidepressant Treatment, neurostimulation, ABT-CIP-10494, Depression, Depressive Disorder, Treatment-Resistant Depressive Disorder, Active-stimulation

Eligibility

You can join if…

Open to people ages 22-70

  1. The patient must be diagnosed with non-psychotic unipolar Major Depressive Disorder.
  2. The patient must be in a major depressive episode for ≥12 months or have had at least 3 lifetime depressive episodes.
  3. The patient has tried and failed a minimum of four different types of antidepressant treatments as measured by a tool designed for this purpose.
  4. Depression medication and treatment regimen must be stable for a minimum of 4 weeks before the first baseline visit

You CAN'T join if...

  1. Pregnant or those who plan to become pregnant during study
  2. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that could limit participation in the study or interfere with adherence to the study protocol.
  3. Current or lifetime history of psychotic features in any Major Depressive Episode.
  4. Has an intracranial Central Nervous System disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication.
  5. Significant acute suicide risk.
  6. Diagnosis of Substance Use Disorder or Alcohol Use Disorder without sustained remission (12 months or longer).
  7. Current and ongoing use of neurostimulation treatment that may interfere with DBS therapy/system.
  8. Treatment with another investigational device or investigational drugs.

Locations

  • UCLA Department of Psychiatry not yet accepting patients
    Los Angeles California 90095 United States
  • University of California at Davis not yet accepting patients
    Sacramento California 95817 United States
  • USC University Hospital not yet accepting patients
    Los Angeles California 90033 United States
  • CHI St. Luke's Health Baylor College of Medicine Med. Ctr accepting new patients
    Houston Texas 77030 United States
  • The Methodist Hospital not yet accepting patients
    Houston Texas 77030 United States
  • University of Minnesota Medical Center Fairview accepting new patients
    Minneapolis Minnesota 55455 United States

Lead Scientists at University of California Health

  • Andrew Leuchter, MD (ucla)
    Professor, Psychiatry and Biobehavioral Sciences, Medicine. Authored (or co-authored) 178 research publications
  • David Brandman, MD (ucdavis)
    Assistant Professor, Med: Neurological Surgery, School of Medicine. Authored (or co-authored) 27 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT06423430
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated