The ISLAND Study: InSuLa Assessed Needs for Depression

NCT02137369 | Completed Phase 4 Results DMC FDA Drug

• 3 other identifiers: IRB00073702R01MH07371900073702
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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

Depression

Keywords

MDD; Major Depressive Disorder; Treatment; Antidepressants; Lexapro; Talk therapy

Outcome Measures

Primary Outcomes (1)

• Number of Remission From Major Depressive Episode Events

  Remission from major depressive episode as assessed by 17-item Hamilton Depression Rating Scale.

  12 weeks

Secondary Outcomes (1)

• Number of Response to Treatment Events

  12 weeks

Study Arms (2)

SSRI

ACTIVE COMPARATOR

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; Other: Combination treatment (SSRI + CBT)

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

Cognitive Behavioral Therapy (CBT) CBT will include 16 1-hour sessions provided over 12 weeks.

Behavioral: Cognitive Behavioral Therapy; Other: Combination treatment (SSRI + CBT)

Interventions

Selective serotonin re-uptake inhibitor DRUG

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

Also known as: Escitalopram or Sertraline, SSRI, Antidepressant medication, Depression treatment

SSRI

Cognitive Behavioral Therapy BEHAVIORAL

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

Also known as: CBT, Depression Treatment, Talk therapy

Cognitive Behavioral Therapy

Combination treatment (SSRI + CBT) OTHER

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

Also known as: Crossover treatment, escitalopram, depression treatment, antidepressant, talk therapy, depression trial

Cognitive Behavioral Therapy; SSRI

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men or women aged 18-60 years.
• Primary psychiatric diagnosis of Major Depressive Disorder, without psychotic features, confirmed via SCID-IV structured diagnostic interview.
• Screening Hamilton Depression Rating Scale (HAMD) ≥ 18; and Baseline HAMD ≥ 15.
• 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.
• Able to understand and provide informed consent for participation.

You may not qualify if:

• Lifetime history of Bipolar Disorder, Dementia, Autism Spectrum Disorder, Schizophrenia, or any other Psychotic Disorder.
• Psychotic symptoms occurring at any time during the current major depressive episode.
• Current (past 12 months) diagnosis of Panic disorder, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, Anorexia Nervosa, or Bulimia Nervosa.
• 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.
• Clinical evidence of a severe Personality Disorder, as assessed by the study psychiatrist, which would impede participation or completion of the trial.
• Known neurological disorders or documented serious head injury.
• Serious and unstable medical illnesses including cardiovascular disease and cancer.
• Active medical conditions with known mood changes (endocrine, autoimmune disorders).
• Current diabetes mellitus.
• For women, pregnancy, lactation, or unwillingness to comply with birth control requirements.
• 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.
• Use of antidepressant medication within 1 month of the pre-treatment PET scan (within 5 weeks for fluoxetine and protryptyline).
• 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).
• Clinically significant active suicidal ideation or self-injurious behavior necessitating immediate treatment, as determined by the investigator.
• Received electroconvulsive therapy in the past 6 months or during the current depressive episode.

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

12 Executive Park Drive, 3rd floor

Atlanta, Georgia, 30329, United States

Location

Related Publications (1)

• Kelley ME, Choi KS, Rajendra JK, Craighead WE, Rakofsky JJ, Dunlop BW, Mayberg HS. Establishing Evidence for Clinical Utility of a Neuroimaging Biomarker in Major Depressive Disorder: Prospective Testing and Implementation Challenges. Biol Psychiatry. 2021 Aug 15;90(4):236-242. doi: 10.1016/j.biopsych.2021.02.966. Epub 2021 Feb 26.

  PMID: 33896622 DERIVED

Related Links

• Study information

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Selective Serotonin Reuptake Inhibitors; Escitalopram; Sertraline; Antidepressive Agents; Cognitive Behavioral Therapy; Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Behavior Therapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Dunlop
• Organization: Emory University

bdunlop@emory.edu

404-727-8969

Study Officials

• Boadie W Dunlop, MD/MS

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 13, 2014
• Study Start: September 1, 2014
• Primary Completion: October 24, 2019
• Study Completion: October 24, 2019
• Last Updated: November 5, 2020
• Results First Posted: November 5, 2020

Record last verified: 2020-10

Locations

US (1)