The ISLAND Study: InSuLa Assessed Needs for Depression (ISLAND)

October 13, 2020 updated by: Boadie W. Dunlop, Emory University

Testing an Imaging Biomarker for Treatment Stratification in Major Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • 12 Executive Park Drive, 3rd floor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men or women aged 18-60 years.
  2. Primary psychiatric diagnosis of Major Depressive Disorder, without psychotic features, confirmed via SCID-IV structured diagnostic interview.
  3. Screening Hamilton Depression Rating Scale (HAMD) ≥ 18; and Baseline HAMD ≥ 15.
  4. If the patient is a woman of child-bearing potential, she must agree to use an acceptable form of birth control for duration of study participation.
  5. Able to understand and provide informed consent for participation.

Exclusion Criteria:

  1. Lifetime history of Bipolar Disorder, Dementia, Autism Spectrum Disorder, Schizophrenia, or any other Psychotic Disorder.
  2. Psychotic symptoms occurring at any time during the current major depressive episode.
  3. Current (past 12 months) diagnosis of Panic disorder, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, Anorexia Nervosa, or Bulimia Nervosa.
  4. Alcohol or Drug Dependence within 12 months or Abuse within 3 months (excluding nicotine and caffeine) of baseline visit, as assessed by history and urine drug screen.
  5. Clinical evidence of a severe Personality Disorder, as assessed by the study psychiatrist, which would impede participation or completion of the trial.
  6. Known neurological disorders or documented serious head injury.
  7. Serious and unstable medical illnesses including cardiovascular disease and cancer.
  8. Active medical conditions with known mood changes (endocrine, autoimmune disorders).
  9. Current diabetes mellitus.
  10. For women, pregnancy, lactation, or unwillingness to comply with birth control requirements.
  11. Use of any of the following treatments or any other alternative therapy within 2 weeks of the pre-treatment PET scan that may have beneficial effects on mood, including St John's Wort, S-adenosyl methionine (SAMe), n-3 fatty acids, or light therapy.
  12. Use of antidepressant medication within 1 month of the pre-treatment PET scan (within 5 weeks for fluoxetine and protryptyline).
  13. Failure to achieve a much improved status (i.e. equivalent to >50% symptom reduction) with 1) any lifetime treatment course of CBT (defined as a minimum of 4 sessions of a specified manual-driven therapy by a CBT-trained therapist) or 2) both escitalopram and sertraline (defined as a minimum of 6 weeks of at the minimum effective dose).
  14. Clinically significant active suicidal ideation or self-injurious behavior necessitating immediate treatment, as determined by the investigator.
  15. Received electroconvulsive therapy in the past 6 months or during the current depressive episode.
  16. Currently responding to medication treatment, without clinical reasons to change.
  17. Current treatment with weekly individual or group psychotherapy of any type targeted at depressive symptoms.
  18. QTc >500 milliseconds on EKG at screening.
  19. Contraindications for MRI, including, but not limited to pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, intra-uterine devices for birth control.

  20. Use of concomitant medications with the exception of:

    • Maintenance or prophylactic therapy for stable medical conditions.
    • Hypnotic medication prescribed or approved by the study physician, (up to a three doses per week) for insomnia, as long if not the night before a PET/MRI or clinic ratings visit. Antipsychotic medications, whether prescribed for sleep or other indications, are prohibited.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SSRI
Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks or Sertraline, pill form, 50 - 150 mg, daily for 12 weeks
Drug: Selective serotonin re-uptake inhibitor
Escitalopram, 20mg-40mg daily or Sertraline 50-150 mg daily for 12 weeks
Other Names:
  • SSRI
  • Escitalopram or Sertraline
  • Antidepressant medication
  • Depression treatment
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.
Other Names:
  • talk therapy
  • escitalopram
  • Crossover treatment
  • depression treatment
  • antidepressant
  • depression trial
Active Comparator: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) CBT will include 16 1-hour sessions provided 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.
Other Names:
  • talk therapy
  • escitalopram
  • Crossover treatment
  • depression treatment
  • antidepressant
  • depression trial
Behavioral: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy, standardized, 16 sessions over 12 weeks.
Other Names:
  • CBT
  • Depression Treatment
  • Talk therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Remission From Major Depressive Episode Events
Time Frame: 12 weeks
Remission from major depressive episode as assessed by 17-item Hamilton Depression Rating Scale.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Response to Treatment Events
Time Frame: 12 weeks
Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Boadie W Dunlop, MD/MS, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

October 24, 2019

Study Completion (Actual)

October 24, 2019

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

October 13, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00073702
  • R01MH073719 (U.S. NIH Grant/Contract)
  • 00073702 (Other Identifier: Emory)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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