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Emotional and Cognitive Control in Late-Onset Depression

Primary Purpose

Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Magnetic Resonance Imaging
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression focused on measuring Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Mental Disorders, Escitalopram, Central Nervous System Agents, Therapeutic Uses, Pharmacologic Actions, Physiological Effects of Drugs, Muscarinic Antagonists, Antidepressive Agents, Psychotropic Drugs, Serotonin Uptake Inhibitors, Neurotransmitter Uptake Inhibitors, Serotonin Agents, Magnetic Resonance Imaging, Functional, fMRI, Magnetic Resonance Imaging

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Weill Cornell Medical College
  • Weill Cornell Medical College - Westchester Division

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Escitalopram

Control

Arm Description

Target dose 20mg for 12 weeks

Non-psychiatric comparison participants.

Outcomes

Primary Outcome Measures

Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale)
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.

Secondary Outcome Measures

Change in Depression Severity (Measured by Hamilton Depression Rating Scale)
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.

Full Information

First Posted
November 12, 2012
Last Updated
September 11, 2020
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01728194
Brief Title
Emotional and Cognitive Control in Late-Onset Depression
Official Title
White Matter and Emotional and Cognitive Control in Late-Onset Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Mental Disorders, Escitalopram, Central Nervous System Agents, Therapeutic Uses, Pharmacologic Actions, Physiological Effects of Drugs, Muscarinic Antagonists, Antidepressive Agents, Psychotropic Drugs, Serotonin Uptake Inhibitors, Neurotransmitter Uptake Inhibitors, Serotonin Agents, Magnetic Resonance Imaging, Functional, fMRI, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
Target dose 20mg for 12 weeks
Arm Title
Control
Arm Type
Other
Arm Description
Non-psychiatric comparison participants.
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro, 76184942
Intervention Description
20 mg target dose for 12 weeks
Intervention Type
Other
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
MRI
Intervention Description
Structural and functional MRI of the brain for research purposes.
Primary Outcome Measure Information:
Title
Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale)
Description
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.
Time Frame
Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)
Secondary Outcome Measure Information:
Title
Change in Depression Severity (Measured by Hamilton Depression Rating Scale)
Description
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.
Time Frame
Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faith Gunning, Ph.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College - Westchester Division
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30236759
Citation
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.
Results Reference
background
PubMed Identifier
35895056
Citation
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.
Results Reference
derived
PubMed Identifier
31901436
Citation
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.
Results Reference
derived
PubMed Identifier
31077981
Citation
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.
Results Reference
derived

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Emotional and Cognitive Control in Late-Onset Depression

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