Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
77 participants
INTERVENTIONAL
2014-09-30
2019-10-24
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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SSRI
Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks or Sertraline, pill form, 50 - 150 mg, daily for 12 weeks
Selective serotonin re-uptake inhibitor
Escitalopram, 20mg-40mg daily or Sertraline 50-150 mg daily for 12 weeks
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.
Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) CBT will include 16 1-hour sessions provided over 12 weeks.
Cognitive Behavioral Therapy
Cognitive Behavioral Therapy, standardized, 16 sessions over 12 weeks.
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.
Interventions
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Selective serotonin re-uptake inhibitor
Escitalopram, 20mg-40mg daily or Sertraline 50-150 mg daily for 12 weeks
Cognitive Behavioral Therapy
Cognitive Behavioral Therapy, standardized, 16 sessions over 12 weeks.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
60 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Emory University
OTHER
Responsible Party
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Boadie W. Dunlop
Professor
Principal Investigators
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Boadie W Dunlop, MD/MS
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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12 Executive Park Drive, 3rd floor
Atlanta, Georgia, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Study information
Other Identifiers
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00073702
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00073702
Identifier Type: -
Identifier Source: org_study_id