Emotional and Cognitive Control in Late-Onset Depression
NCT ID: NCT01728194
Last Updated: 2020-10-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
121 participants
INTERVENTIONAL
2012-07-31
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Escitalopram
Target dose 20mg for 12 weeks
Escitalopram
20 mg target dose for 12 weeks
Magnetic Resonance Imaging
Structural and functional MRI of the brain for research purposes.
Control
Non-psychiatric comparison participants.
Magnetic Resonance Imaging
Structural and functional MRI of the brain for research purposes.
Interventions
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Escitalopram
20 mg target dose for 12 weeks
Magnetic Resonance Imaging
Structural and functional MRI of the brain for research purposes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis: Major depression, unipolar (by Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)IV (SCID-R) and DSM-IV criteria);
* Age of onset of first episode ≥ 50 years with up to three depressive episodes;
* Severity of depression: A 24-Item Hamilton Depression Rating Scale (HDRS) ≥ 20.
Exclusion Criteria
* High suicide risk, i.e. intent or plan to attempt suicide in near future;
* Presence of any Axis I psychiatric disorder (other than unipolar major depression) or substance abuse;
* Dementia: Diagnosis of dementia by DSM-IV;
* Mild Cognitive Impairment (MCI);
* Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or use of drugs known to cause depression, e.g., reserpine, alpha-methyl-dopa, steroids, sympathomimetics withdrawal;
* Neurological brain disease and/or history of electroconvulsive therapy;
* History of any use of citalopram or escitalopram during the current episode or need for drugs that may interact with these agents, i.e. drug metabolized by the 2D6 P450 isoenzyme system;
* Current involvement in psychotherapy;
* Contraindications to MRI scanning including cardiac pacemaker, metallic objects and metallic implants contraindicating MRI, cardiac stent, claustrophobia;
* Inability to speak English;
* Corrected visual acuity \< 20/70; Color blindness.
60 Years
85 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Faith Gunning, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Weill Cornell Medical College
New York, New York, United States
Weill Cornell Medical College - Westchester Division
White Plains, New York, United States
Countries
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References
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Victoria LW, Alexopoulos GS, Ilieva I, Stein AT, Hoptman MJ, Chowdhury N, Respino M, Morimoto SS, Kanellopoulos D, Avari JN, Gunning FM. White matter abnormalities predict residual negative self-referential thinking following treatment of late-life depression with escitalopram: A preliminary study. J Affect Disord. 2019 Jan 15;243:62-69. doi: 10.1016/j.jad.2018.09.013. Epub 2018 Sep 11.
Oberlin LE, Victoria LW, Ilieva I, Dunlop K, Hoptman MJ, Avari J, Alexopoulos GS, Gunning FM. Comparison of Functional and Structural Neural Network Features in Older Adults With Depression With vs Without Apathy and Association With Response to Escitalopram: Secondary Analysis of a Nonrandomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2224142. doi: 10.1001/jamanetworkopen.2022.24142.
Respino M, Hoptman MJ, Victoria LW, Alexopoulos GS, Solomonov N, Stein AT, Coluccio M, Morimoto SS, Blau CJ, Abreu L, Burdick KE, Liston C, Gunning FM. Cognitive Control Network Homogeneity and Executive Functions in Late-Life Depression. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Feb;5(2):213-221. doi: 10.1016/j.bpsc.2019.10.013. Epub 2019 Nov 7.
Respino M, Jaywant A, Kuceyeski A, Victoria LW, Hoptman MJ, Scult MA, Sankin L, Pimontel M, Liston C, Belvederi Murri M, Alexopoulos GS, Gunning FM. The impact of white matter hyperintensities on the structural connectome in late-life depression: Relationship to executive functions. Neuroimage Clin. 2019;23:101852. doi: 10.1016/j.nicl.2019.101852. Epub 2019 May 3.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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1205012392
Identifier Type: -
Identifier Source: org_study_id
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