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. Identifier: NCT00105586
Recruitment Status : Completed
First Posted : March 16, 2005
Results First Posted : May 8, 2017
Last Update Posted : May 8, 2017
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
257 subjects consented (177 randomized and received treatment)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
78 excluded from randomization due to ineligibility and/or refusal; 2 excluded after randomization but did not start treatment

Reporting Groups
Placebo Participants will receive a placebo.
Escitalopram Participants will receive escitalopram.

Participant Flow:   Overall Study
    Placebo   Escitalopram
STARTED   92   85 
COMPLETED   75   69 
NOT COMPLETED   17   16 
Adverse Event                4                3 
Physician Decision                13                13 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Placebo Participants will receive a placebo.
Escitalopram Participants will receive escitalopram.
Total Total of all reporting groups

Baseline Measures
   Placebo   Escitalopram   Total 
Overall Participants Analyzed 
[Units: Participants]
 92   85   177 
[Units: Participants]
Count of 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% 
[Units: Years]
Mean (Standard Deviation)
 72.2  (8.2)   71.1  (7.4)   71.6  (9.9999) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      58  63.0%      61  71.8%      119  67.2% 
Male      34  37.0%      24  28.2%      58  32.8% 
Region of Enrollment 
[Units: Participants]
United States   92   85   177 

  Outcome Measures

1.  Primary:   Response Using Clinical Global Impressions-Improvement Scale (CGI-I)   [ Time Frame: Measured at Weeks 1-12 ]

2.  Secondary:   Quality of Life   [ Time Frame: Measured at Week 12 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Eric Lenze
Organization: Washington University in St. Louis
phone: 314-362-1671

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Eric Lenze, University of Pittsburgh 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