Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

Purpose

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.

Keywords: DBS, Deep Brain Stimulation, Major Depressive Disorder, Depression, MDD, Bilateral Stimulation, Antidepressant Treatment, neurostimulation, ABT-CIP-10494, Depressive Disorder, Mood Disorders, Mental Disorders, Treatment-Resistant Depressive Disorder

Study Sites

University of Southern California Health Sciences Campus, Los Angeles, California 90033

 
  • Men & Women
Age icon
22 - 70
 
 
To find out if you qualify for the study contact Janet Sobell at Sobell@med.usc.edu or (424) 240-9310. 
 

What's involved?

Study length

  • 12 Months

Number of visits

  • Contact the study team for more information.

Prescription
    None
Procedures
Compensation

  • May be available, please contact the study team.

Medical cost coverage
    None

Why participate?

Medical advances are impossible without volunteers.

Eligibility

Must have

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

Can't have

  • Pregnant or those who plan to become pregnant during study.
  • 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.
  • Current or lifetime history of psychotic features in any Major Depressive Episode.
  • Has an intracranial Central Nervous System disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication.
  • Significant acute suicide risk.
  • Diagnosis of Substance Use Disorder or Alcohol Use Disorder without sustained remission (12 months or longer).
  • Current and ongoing use of neurostimulation treatment that may interfere with DBS therapy/system.
  • Treatment with another investigational device or investigational drugs.

Visit our Website

https://sites.usc.edu/FrankOCDLab/current-research/

Study Team

Photohandler
Principal Investigator
Adam Frank

For questions about this study, contact:

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