A Clinical Pilot Study Examining Bilateral Inhibition of the Lateral Habenula as a Target for Deep Brain Stimulation in Intractable Depression
ID Number 12-1815Principal Investigator(s)
Department(s) or Division(s)
The Departments of Psychiatry and Neurosurgery at the Icahn School of Medicine at Mount Sinai are currently seeking participants with treatment-resistant depression (TRD) for research assessing the safety and preliminary efficacy of a neurosurgical intervention, Deep Brain Stimulation (DBS), targeting a brain region called the lateral habenula. The lateral habenula has been implicated in producing depressive symptoms in animals and in humans, and this pilot study will investigate whether DBS at this target might relieve depressive symptoms in six severe, treatment-resistant patients.
To pre-qualify for this study, patients must:
- Be between the ages of 21 and 70 years.
- Have a diagnosis of major depression secondary to either nonpsychotic unipolar major depressive disorder (MDD) or bipolar disorder (BD) I.
- Have failed to respond to a minimum of three adequate depression treatments from at least two different treatment categories (e.g., SSRIs, TCAs, other antidepressants, lithium addition, MAO inhibitor, augmentation with an atypical antipsychotic).
- Have failed to respond to a trial of ECT.
- Be medically stable.
All study procedures, including devices, surgery, and follow up psychiatric assessments will be provided at no cost to patients who enroll.
Recruiting Patients: Yes