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Trial record 7 of 490 for:    ESCITALOPRAM AND Antagonists

Emotional and Cognitive Control in Late-Onset Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01728194
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : August 30, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 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
Actual Study Start Date : July 2012
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

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. Range from 0 to 72 with 0 being lowest symptom severity and 72 indicating severe depression


Secondary Outcome Measures :
  1. Hamilton Depression Rating Scale (Depression Severity) [ Time Frame: 12 weeks ]
    A clinician rating of mood. Range from 0 to 72 with 0 being lowest symptom severity and 72 indicating severe depression


Other Outcome Measures:
  1. Diagnostic Status [ Time Frame: Baseline ]
    Diagnostic status based on structured clinical interview



Information from the National Library of Medicine

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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 ≥ 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.

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


Locations
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United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Weill Cornell Medical College - Westchester Division
White Plains, New York, United States, 10605
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Faith Gunning, Ph.D. Weill Medical College of Cornell University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01728194     History of Changes
Other Study ID Numbers: 1205012392
1R01MH097735-01 ( U.S. NIH Grant/Contract )
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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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
Keywords provided by Weill Medical College of Cornell University:
Escitalopram
Muscarinic Antagonists
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Magnetic Resonance Imaging, Functional
fMRI
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Dexetimide
Citalopram
Muscarinic Antagonists
Cholinergic Antagonists
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin
Serotonin Uptake Inhibitors
Neurotransmitter 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
Cholinergic Agents
Serotonin Receptor Agonists