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ISLAND Depression Study

Title: Insula Assessed Needs for Depression (ISLAND)

Principal Investigator: Helen S. Mayberg, MD

Population:  Patients with Major Depression between the ages of 18-55 who are not currently taking medication and have never received Cognitive Behavioral Therapy (CBT) and have never met criteria for  Bipolar disorder, Psychotic Disorder, Dementia, Autism Spectrum Disorder, or Schizophrenia. Patients with a current primary diagnosis of Panic Disorder, OCD, PTSD, or an eating disorder are also excluded.

Summary: Although there are many effective options for treating a major depressive episode, there are no clinical markers that predict the likelihood of remission with an initial trial of either an antidepressant medication or psychotherapy. To test whether insula metabolism can predict treatment outcomes in MDD, patients will be randomized to a 12 week treatment of either CBT therapy or Escitalopram (Lexapro) and receive a PET and MRI scan at the beginning and end of Phase 1. Treatment success will be determined by blind ratings. The study aims to determine if brain scans might help physicians to select the most effective treatment for an individual patient with Major Depression.

Subjects will be randomized to receive either Escitalopram (Lexapro) or CBT for 12 weeks. Resting-state positron emission tomography (PET) and BOLD functional magnetic resonance imaging (fMRI) scans will be done before the treatment begins, and again at the end of treatment (week 12). Non-remitters to Lexapro or CBT will receive combination treatment with both Escitalopram and CBT for an additional 12 weeks of treatment.

Procedure: General screening process, physical exam, blood draw, self-report questionnaires, PET scan, MRI scan, treatment of CBT therapy or Escitalopram

Compensation: Phase 1: $10 gas card Baseline visit, Week 2, 4, 8, and 12. Phase 2: Non-remitters receive a $10 gas card at Week 14, 16, 20, 24.

Contact:
Phone (MAP Line): 404-778-6663 (MOOD)
Patients can go to:
www.emoryclinicaltrials.com
www.clinicaltrials.gov