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Trial record 25 of 2812 for:    Rating | "Depressive Disorder"

Emotional and Cognitive Control in Late-Onset Depression

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ClinicalTrials.gov Identifier: NCT01728194
Recruitment Status : Recruiting
First Posted : November 16, 2012
Last Update Posted : February 27, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Faith Gunning, Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Depression Drug: Escitalopram Phase 4

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  (Clinical Trial)
Estimated Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: White Matter and Emotional and Cognitive Control in Late-Onset Depression
Study Start Date : July 2012
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Escitalopram
Target dose 20mg for 12 weeks
Drug: Escitalopram
20 mg target dose for 12 weeks
Other Names:
  • Lexapro
  • 76184942




Primary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale (Depression Severity) [ Time Frame: 12 weeks ]
    A clinician rating of mood.


Secondary Outcome Measures :
  1. Hamilton Depression Rating Scale (Depression Severity) [ Time Frame: 12 weeks ]
    A clinician rating of mood.



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 ≥ 60 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728194


Contacts
Contact: Faith Gunning, Ph.D. 914-997-8643 fgd2002@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College - Westchester Division Recruiting
White Plains, New York, United States, 10605
Contact: Faith Gunning, Ph.D.    914-997-8643    fgd2002@med.cornell.edu   
Principal Investigator: Faith Gunning, Ph.D.         
Sub-Investigator: George Alexopoulos, M.D.         
Sub-Investigator: Sibel Klimstra, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Faith Gunning, Ph.D. Weill Medical College of Cornell University

Responsible Party: Faith Gunning, Associate Professor of Psychology in Psychiatry at Weill Cornell, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01728194     History of Changes
Other Study ID Numbers: 1R01MH097735-01 ( U.S. NIH Grant/Contract )
1R01MH097735-01 ( U.S. NIH Grant/Contract )
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

Keywords provided by Faith Gunning, Weill Medical College of Cornell University:
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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Dexetimide
Serotonin
Neurotransmitter Uptake Inhibitors
Serotonin Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Serotonin Receptor Agonists