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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Anxiety Disorders
Generalized Anxiety Disorder
Intervention Drug: Escitalopram
Enrollment 177
Recruitment Details 257 subjects consented (177 randomized and received treatment)
Pre-assignment Details 78 excluded from randomization due to ineligibility and/or refusal; 2 excluded after randomization but did not start treatment
Arm/Group Title Placebo Escitalopram
Hide Arm/Group Description Participants will receive a placebo. Participants will receive escitalopram.
Period Title: Overall Study
Started 92 85
Completed 75 69
Not Completed 17 16
Reason Not Completed
Adverse Event             4             3
Physician Decision             13             13
Arm/Group Title Placebo Escitalopram Total
Hide Arm/Group Description Participants will receive a placebo. Participants will receive escitalopram. Total of all reporting groups
Overall Number of Baseline Participants 92 85 177
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 85 participants 177 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
92
 100.0%
85
 100.0%
177
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants 85 participants 177 participants
72.2  (8.2) 71.1  (7.4) 71.6  (9.9999)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 85 participants 177 participants
Female
58
  63.0%
61
  71.8%
119
  67.2%
Male
34
  37.0%
24
  28.2%
58
  32.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 92 participants 85 participants 177 participants
92 85 177
1.Primary Outcome
Title Response Using Clinical Global Impressions-Improvement Scale (CGI-I)
Hide Description 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).
Time Frame Measured at Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Escitalopram
Hide Arm/Group Description:
Participants will receive a placebo.
Participants will receive escitalopram.
Overall Number of Participants Analyzed 75 69
Measure Type: Number
Unit of Measure: participants
51 69
2.Secondary Outcome
Title Quality of Life
Hide Description Role -emotional impairment score from the Late-Life Function and Disability Instrument (min score=0, significant impairment; max score=100, no impairment).
Time Frame Measured at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Quality of Life scales were collected on all participants randomized to Escitalopram and placebo
Arm/Group Title Escitalopram (1) Placebo (2)
Hide Arm/Group Description:

Escitalopram

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.

Placebo

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.

Overall Number of Participants Analyzed 85 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 SF-36 Role-Emotional Impairment 42.19  (36.72) 53.42  (38.39)
Week 12 SF-36 Role-Emotional Impairment 62.50  (37.80) 56.16  (38.83)
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Escitalopram
Hide Arm/Group Description Participants will receive a placebo. Participants will receive escitalopram.
All-Cause Mortality
Placebo Escitalopram
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Escitalopram
Affected / at Risk (%) Affected / at Risk (%)
Total   0/92 (0.00%)   0/85 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Escitalopram
Affected / at Risk (%) Affected / at Risk (%)
Total   59/92 (64.13%)   65/85 (76.47%) 
Gastrointestinal disorders     
Gastrointestinal upset *  26/92 (28.26%)  22/85 (25.88%) 
General disorders     
Fatigue or somnolence *  10/92 (10.87%)  25/85 (29.41%) 
Headache *  7/92 (7.61%)  13/85 (15.29%) 
Sleep disturbance *  2/92 (2.17%)  12/85 (14.12%) 
Musculoskeletal and connective tissue disorders     
Aches *  14/92 (15.22%)  5/85 (5.88%) 
Nervous system disorders     
Sweating *  5/92 (5.43%)  11/85 (12.94%) 
Light-headedness *  7/92 (7.61%)  7/85 (8.24%) 
Tremor *  2/92 (2.17%)  7/85 (8.24%) 
Psychiatric disorders     
Increased anxiety or depression *  9/92 (9.78%)  7/85 (8.24%) 
Renal and urinary disorders     
Urinary symptoms * [1]  0/92 (0.00%)  8/85 (9.41%) 
Reproductive system and breast disorders     
Sexual *  3/92 (3.26%)  9/85 (10.59%) 
Skin and subcutaneous tissue disorders     
Rash or pruritus *  6/92 (6.52%)  5/85 (5.88%) 
*
Indicates events were collected by non-systematic assessment
[1]
increased or decreased frequency and urgency
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eric Lenze
Organization: Washington University in St. Louis
Phone: 314-362-1671
EMail: lenzee@wustl.edu
Layout table for additonal information
Responsible Party: Eric Lenze, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00105586     History of Changes
Other Study ID Numbers: R01MH070547 ( U.S. NIH Grant/Contract )
R01MH070547 ( U.S. NIH Grant/Contract )
First Submitted: March 15, 2005
First Posted: March 16, 2005
Results First Submitted: August 3, 2009
Results First Posted: May 8, 2017
Last Update Posted: May 8, 2017