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Trial record 39 of 536 for:    ESCITALOPRAM AND Disorders

Drug Therapy for Generalized Anxiety Disorder Among the Elderly

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: NCT00105586
Recruitment Status : Completed
First Posted : March 16, 2005
Results First Posted : May 8, 2017
Last Update Posted : May 8, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Eric Lenze, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE March 15, 2005
First Posted Date  ICMJE March 16, 2005
Results First Submitted Date  ICMJE August 3, 2009
Results First Posted Date  ICMJE May 8, 2017
Last Update Posted Date May 8, 2017
Study Start Date  ICMJE December 2004
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
Response Using Clinical Global Impressions-Improvement Scale (CGI-I) [ Time Frame: Measured at Weeks 1-12 ]
Cumulative incident response of anxiety symptom improvement on CGI-I, with 1 (very much improved) to 2 (much improved) indicated as response. Scores synthesized from anxiety rating scale scores, including Penn State Worry Questionnaire (PSWQ) and Hamilton Anxiety Scale (HamA).
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Anxiety symptoms
Change History Complete list of historical versions of study NCT00105586 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
Quality of Life [ Time Frame: Measured at Week 12 ]
Role -emotional impairment score from the Late-Life Function and Disability Instrument (min score=0, significant impairment; max score=100, no impairment).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Quality of Life
  • Cognitive function
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug Therapy for Generalized Anxiety Disorder Among the Elderly
Official Title  ICMJE Pharmacotherapy of Late-Life Generalized Anxiety Disorder
Brief Summary This study will determine the efficacy of escitalopram (Lexapro®), an anti-anxiety drug, for generalized anxiety disorder (GAD) and the ways genetics affect response to treatment for GAD in elderly individuals.
Detailed Description

GAD is a serious public health issue; particularly among the elderly, prevalence of the condition is high, and functional burden on those with the illness is significant. GAD is associated with irregular levels of neurotransmitters, chemicals that carry messages across nerve endings. Serotonin is a neurotransmitter that helps regulate mood and emotions; increased levels of serotonin have been shown to reduce anxiety. Standard treatment for GAD typically involves selective serotonin reuptake inhibitors (SSRIs), drugs that reduce serotonin re-entry into nerve cells. Escitalopram is an SSRI that is well tolerated and highly specific for the serotonin transporter (SERT). The primary aim of this study is to examine the efficacy of escitalopram in reducing anxiety symptoms among elderly GAD patients. Additional aims include examining the efficacy of escitalopram for improving function, quality of life, and neuropsychological functioning, and examining whether genetic variation in the SERT gene influences these participants' response to treatment.

Participants will be randomly assigned to receive either escitalopram or placebo for 12 weeks (there is also a 12 week open label extension in which all participants will receive escitalopram). Participants will have weekly/biweekly study visits; during these visits, participants will complete self-report questionnaires on functional ability and anxiety symptoms. Blood collection and cognitive testing through various tasks will also occur.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Anxiety Disorders
  • Generalized Anxiety Disorder
Intervention  ICMJE Drug: Escitalopram
Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram.
Other Name: Lexapro
Study Arms  ICMJE
  • Experimental: Escitalopram (1)
    Escitalopram
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo (2)
    Placebo
    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: December 10, 2007)
177
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
176
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of at least moderately severe generalized anxiety disorder (GAD)

Exclusion Criteria:

  • Serious suicide risk or psychiatric instability that would affect study participation
  • Dementia
  • Substance abuse, such as alcoholism, within 6 months prior to study entry
  • Diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or bipolar disorder
  • Unstable medical conditions that would preclude the use of escitalopram
  • Use of certain psychotropics that can not be safely tapered or discontinued for at least 2 weeks prior to and during the study
  • Use of neuroleptics that are absorbed over a prolonged period of time within 6 weeks prior to study entry
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT00105586
Other Study ID Numbers  ICMJE R01MH070547( U.S. NIH Grant/Contract )
R01MH070547 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: interested investigators should contact the PI directly via email.
Responsible Party Eric Lenze, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Eric J. Lenze, MD University of Pittsburgh Medical Center
PRS Account University of Pittsburgh
Verification Date May 2017

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