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Trial record 7 of 491 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

Tracking Information
First Submitted Date  ICMJE November 12, 2012
First Posted Date  ICMJE November 16, 2012
Last Update Posted Date August 30, 2019
Actual Study Start Date  ICMJE July 2012
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 12, 2012)
Montgomery Asberg Depression Rating Scale (Depression Severity) [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT01728194 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2019)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2012)
Hamilton Depression Rating Scale (Depression Severity) [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: August 27, 2019)
Diagnostic Status [ Time Frame: Baseline ]
Diagnostic status based on structured clinical interview
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Emotional and Cognitive Control in Late-Onset Depression
Official Title  ICMJE White Matter and Emotional and Cognitive Control in Late-Onset Depression
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Depression
Intervention  ICMJE Drug: Escitalopram
20 mg target dose for 12 weeks
Other Names:
  • Lexapro
  • 76184942
Study Arms  ICMJE Experimental: Escitalopram
Target dose 20mg for 12 weeks
Intervention: Drug: Escitalopram
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2019)
121
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2012)
140
Actual Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01728194
Other Study ID Numbers  ICMJE 1205012392
1R01MH097735-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Faith Gunning, Ph.D. Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP