Emotional and Cognitive Control in Late-Onset Depression

NCT01728194 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 12050123921R01MH097735-01
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)

Secondary Outcomes (1)

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

  Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)

Study Arms (2)

Escitalopram

EXPERIMENTAL

Target dose 20mg for 12 weeks

Drug: Escitalopram; Other: Magnetic Resonance Imaging

Control

OTHER

Non-psychiatric comparison participants.

Other: Magnetic Resonance Imaging

Interventions

Escitalopram DRUG

20 mg target dose for 12 weeks

Also known as: Lexapro, 76184942

Escitalopram

Magnetic Resonance Imaging OTHER

Structural and functional MRI of the brain for research purposes.

Also known as: MRI

Control; Escitalopram

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Weill Cornell Medical College - Westchester Division

White Plains, New York, 10605, United States

Location

Related Publications (4)

• 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.

  PMID: 30236759 BACKGROUND

• 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.

  PMID: 35895056 DERIVED

• 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.

  PMID: 31901436 DERIVED

• 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.

  PMID: 31077981 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders

Interventions

Escitalopram; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Faith M. Gunning, PhD, Vice Chair for Research, Dept of Psychiatry
• Organization: Well Cornell Medicine

fgd2002@med.cornell.edu

212-746-5832

Study Officials

• Faith Gunning, Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2012
• First Posted: November 16, 2012
• Study Start: July 1, 2012
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: October 6, 2020
• Results First Posted: October 6, 2020

Record last verified: 2020-09

Locations

US (2)