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Depression | The ISLAND Study: InSuLa Assessed Needs for Depression

Depression research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:EscitalopramEscitalopram, 20mg-40mg daily for 12 weeks

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

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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

EscitalopramEscitalopram, pill form, 20mg-40mg, daily, for 12 weeks

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

Study Status

Recruiting

Start Date: September 2014

Completed Date: June 2019

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Remission from major depressive episode

Secondary Outcome: Response to treatment

Study sponsors, principal investigator, and references

Principal Investigator: Boadie W Dunlop, MD/MS

Lead Sponsor: Emory University

Collaborator: National Institute of Mental Health (NIMH)

More information:https://clinicaltrials.gov/show/NCT02137369

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