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Completed

NCT Number: NCT01728194

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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Weill Cornell Medical College, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Escitalopram

Drug

20 mg target dose for 12 weeks

Other names: Lexapro, 76184942

Magnetic Resonance Imaging

Other

Structural and functional MRI of the brain for research purposes.

Other names: MRI

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

White Matter and Emotional and Cognitive Control in Late-Onset Depression

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Nov 16, 2012
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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