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The ISLAND Study: InSuLa Assessed Needs for Depression

NCT02137369 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2020-11-05

Study results available
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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.

Conditions

Interventions

DRUG

Selective serotonin re-uptake inhibitor

Escitalopram, 20mg-40mg daily or Sertraline 50-150 mg daily for 12 weeks

BEHAVIORAL

Cognitive Behavioral Therapy

Cognitive Behavioral Therapy, standardized, 16 sessions over 12 weeks.

OTHER

Combination treatment (SSRI + CBT)

study participants who do not remit in the first 12 weeks will be offered combination treatment of both treatments for 12 more weeks.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Boadie W Dunlop, MD/MS · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2019-10-24
Completion
2019-10-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02137369 on ClinicalTrials.gov