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

This study is currently recruiting participants.
Verified November 2016 by Helen Mayberg, Emory University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02137369
First Posted: May 13, 2014
Last Update Posted: November 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Helen Mayberg, Emory University
  Purpose

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 escitalopram ((s-CIT) - Lexapro®), an FDA approved antidepressant. The study aims to determine if bran scan findings might help physicians to select the most effective antidepressant treatment for an individual patient.

At total of 150 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.


Condition Intervention Phase
Depression Drug: Escitalopram Behavioral: Cognitive Behavioral Therapy Other: Combination treatment (Escitalopram + CBT) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Testing an Imaging Biomarker for Treatment Stratification in Major Depression

Resource links provided by NLM:


Further study details as provided by Helen Mayberg, Emory University:

Primary Outcome Measures:
  • Remission from major depressive episode [ Time Frame: 12 weeks ]
    Remission from major depressive episode as assessed by 17-item Hamilton Depression Rating Scale.


Secondary Outcome Measures:
  • Response to treatment [ Time Frame: 12 weeks ]
    Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks


Estimated Enrollment: 150
Study Start Date: September 2014
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Escitalopram
Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks
Drug: Escitalopram
Escitalopram, 20mg-40mg daily for 12 weeks
Other Names:
  • Lexapro
  • SSRI
  • Antidepressant medication
  • Depression treatment
Other: Combination treatment (Escitalopram + 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:
  • Crossover treatment
  • escitalopram
  • depression treatment
  • antidepressant
  • talk therapy
  • depression trial
Active Comparator: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) CBT will include 16 1-hour sessions provided over 12 weeks.
Behavioral: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy, standardized, 16 sessions over 12 weeks.
Other Names:
  • CBT
  • Depression Treatment
  • Talk therapy
Other: Combination treatment (Escitalopram + 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:
  • Crossover treatment
  • escitalopram
  • depression treatment
  • antidepressant
  • talk therapy
  • depression trial

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 escitalopram (defined as a minimum of 6 weeks of at least 10 mg/day).
  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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137369


Contacts
Contact: Tanja C Mletzko Crowe, MA 404-712-5063 tmletzk@emory.edu
Contact: Boadie W Dunlop, MD/MS 404-778-6663 bdunlop@emory.edu

Locations
United States, Georgia
12 Executive Park Drive, 3rd floor Recruiting
Atlanta, Georgia, United States, 30329
Principal Investigator: Helen Mayberg, MD         
Sub-Investigator: Boadie W Dunlop, MD/MS         
Sub-Investigator: W. Edward Craighead, PhD         
Sponsors and Collaborators
Emory University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Helen Mayberg, MD Emory University
Study Director: Boadie W Dunlop, MD/MS Emory University
  More Information

Additional Information:
Responsible Party: Helen Mayberg, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02137369     History of Changes
Other Study ID Numbers: IRB00073702
R01MH073719 ( U.S. NIH Grant/Contract )
00073702 ( Other Identifier: Emory )
First Submitted: May 12, 2014
First Posted: May 13, 2014
Last Update Posted: November 23, 2016
Last Verified: November 2016

Keywords provided by Helen Mayberg, Emory University:
MDD
Major Depressive Disorder
Treatment
Antidepressants
Lexapro
Talk therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Citalopram
Dexetimide
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents