- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01728194
Emotional and Cognitive Control in Late-Onset Depression
September 11, 2020 updated by: Weill Medical College of Cornell University
White Matter and Emotional and Cognitive Control in Late-Onset Depression
This study may help identify how abnormalities in brain systems that control the ability to ignore irrelevant information may contribute to the development of depression in older adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Approximately half of those who develop depression in late life never had depression before.
The classic view is that changes taking place in our brains as we age contribute to the development of late-onset depression.
This view is supported by the relative absence of family history for those with late onset depression.
This research study will recruit 70 older adults with late life depression and 70 older adults without depression.
All participants will receive a sub-clinical, non-contrast (magnetic resonance imaging (MRI) scan at the beginning of the study and then again 12 weeks later at the completion of the study.
The depressed older participants will also receive a Food and Drug Administration (FDA)-approved antidepressant, escitalopram (Lexapro), as treatment for their depressive symptoms over 12 weeks.
This MRI study may help the researchers identify how abnormalities in brain systems that control our ability to ignore distractions, control our emotions, and anticipate reward may contribute to the development of depression in older adults.
The investigators hope that the findings promote the development of tests that may improve the detection of older adults at risk for poor treatment outcomes and eventually guide the development of novel treatments for depression.
Study Type
Interventional
Enrollment (Actual)
121
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Weill Cornell Medical College
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White Plains, New York, United States, 10605
- Weill Cornell Medical College - Westchester Division
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: 60-85 years, right-handed;
- 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:
- Psychotic depression by DSM-IV, i.e., presence of delusions with a SCID-R score higher than 2;
- 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;
- History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, and dysthymia are exclusion criteria);
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Escitalopram
Target dose 20mg for 12 weeks
|
20 mg target dose for 12 weeks
Other Names:
Structural and functional MRI of the brain for research purposes.
Other Names:
|
OTHER: Control
Non-psychiatric comparison participants.
|
Structural and functional MRI of the brain for research purposes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale)
Time Frame: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)
|
Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Montgomery Asberg Depression Rating Scale (MADRS).
This measure is a clinical rating of mood with a score range from 0 to 60. Higher scores indicate greater depression severity.
|
Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depression Severity (Measured by Hamilton Depression Rating Scale)
Time Frame: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)
|
Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Hamilton Depression Rating Scale (HAM-D).
This measure is a clinical rating of mood with a score range from 0 to 76. Higher scores indicate greater depression severity.
|
Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Faith Gunning, Ph.D., Weill Medical College of Cornell University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2012
Primary Completion (ACTUAL)
July 31, 2019
Study Completion (ACTUAL)
July 31, 2019
Study Registration Dates
First Submitted
November 12, 2012
First Submitted That Met QC Criteria
November 12, 2012
First Posted (ESTIMATE)
November 16, 2012
Study Record Updates
Last Update Posted (ACTUAL)
October 6, 2020
Last Update Submitted That Met QC Criteria
September 11, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
- Depression
- Mood Disorders
- Depressive Disorder
- Magnetic Resonance Imaging
- fMRI
- Physiological Effects of Drugs
- Central Nervous System Agents
- Mental Disorders
- Pharmacologic Actions
- Antidepressive Agents
- Therapeutic Uses
- Escitalopram
- Psychotropic Drugs
- Behavioral Symptoms
- Muscarinic Antagonists
- Serotonin Uptake Inhibitors
- Serotonin Agents
- Neurotransmitter Uptake Inhibitors
- Magnetic Resonance Imaging, Functional
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- 1205012392
- 1R01MH097735-01 (NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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