The ISLAND Study: InSuLa Assessed Needs for Depression
Status:
Completed
Trial end date:
2019-10-24
Target enrollment:
Participant gender:
Summary
While 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. The goal of this study is to test how brain
function changes in depress patients treated with cognitive behavioral therapy (CBT) compared
to patients treated with a selective serotonin reuptake inhibitor (SSRI, either escitalopram
or sertraline), which are FDA approved antidepressants. The study aims to determine if bran
scan findings might help physicians to select the most effective antidepressant treatment for
an individual patient.
Up to 100 male and female outpatients who are between 21-55 years old will be enrolled.
Participation in the study will last from 14-26 weeks.
Subjects will be randomized to receive either escitalopram (s-CIT) 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-responders to s-cIT or CBT will be crossed over to receive an
additional 12 weeks of treatment with the alternative intervention.