Trial Outcomes & Findings for Drug Therapy for Generalized Anxiety Disorder Among the Elderly (NCT NCT00105586)

Last Updated: 2017-05-08

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

177 participants

Primary outcome timeframe

Measured at Weeks 1-12

Results posted on

2017-05-08

Participant Flow

257 subjects consented (177 randomized and received treatment)

78 excluded from randomization due to ineligibility and/or refusal; 2 excluded after randomization but did not start treatment

Participant milestones

Participant milestones
Measure	Placebo Participants will receive a placebo.	Escitalopram Participants will receive escitalopram.
Overall Study STARTED	92	85
Overall Study COMPLETED	75	69
Overall Study NOT COMPLETED	17	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants will receive a placebo.	Escitalopram Participants will receive escitalopram.
Overall Study Adverse Event	4	3
Overall Study Physician Decision	13	13

Baseline Characteristics

Drug Therapy for Generalized Anxiety Disorder Among the Elderly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=92 Participants Participants will receive a placebo.	Escitalopram n=85 Participants Participants will receive escitalopram.	Total n=177 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	92 Participants n=5 Participants	85 Participants n=7 Participants	177 Participants n=5 Participants
Age, Continuous	72.2 years STANDARD_DEVIATION 8.2 • n=5 Participants	71.1 years STANDARD_DEVIATION 7.4 • n=7 Participants	71.6 years STANDARD_DEVIATION 9.9999 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	61 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	24 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment United States	92 participants n=5 Participants	85 participants n=7 Participants	177.0 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at Weeks 1-12

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Participants will receive a placebo.	Escitalopram n=69 Participants Participants will receive escitalopram.
Response Using Clinical Global Impressions-Improvement Scale (CGI-I)	51 participants	69 participants

SECONDARY outcome

Timeframe: Measured at Week 12

Population: Quality of Life scales were collected on all participants randomized to Escitalopram and placebo

Role -emotional impairment score from the Late-Life Function and Disability Instrument (min score=0, significant impairment; max score=100, no impairment).

Outcome measures

Outcome measures
Measure	Placebo n=85 Participants Participants will receive a placebo.	Escitalopram n=92 Participants Participants will receive escitalopram.
Quality of Life Week 0 SF-36 Role-Emotional Impairment	42.19 units on a scale Standard Deviation 36.72	53.42 units on a scale Standard Deviation 38.39
Quality of Life Week 12 SF-36 Role-Emotional Impairment	62.50 units on a scale Standard Deviation 37.80	56.16 units on a scale Standard Deviation 38.83

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 59 other events

Deaths: 0 deaths

Escitalopram

Serious events: 0 serious events

Other events: 65 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=92 participants at risk Participants will receive a placebo.	Escitalopram n=85 participants at risk Participants will receive escitalopram.
General disorders Fatigue or somnolence	10.9% 10/92 • 3 months	29.4% 25/85 • 3 months
Gastrointestinal disorders Gastrointestinal upset	28.3% 26/92 • 3 months	25.9% 22/85 • 3 months
General disorders Headache	7.6% 7/92 • 3 months	15.3% 13/85 • 3 months
General disorders Sleep disturbance	2.2% 2/92 • 3 months	14.1% 12/85 • 3 months
Nervous system disorders Sweating	5.4% 5/92 • 3 months	12.9% 11/85 • 3 months
Renal and urinary disorders Urinary symptoms	0.00% 0/92 • 3 months	9.4% 8/85 • 3 months
Psychiatric disorders Increased anxiety or depression	9.8% 9/92 • 3 months	8.2% 7/85 • 3 months
Nervous system disorders Light-headedness	7.6% 7/92 • 3 months	8.2% 7/85 • 3 months
Nervous system disorders Tremor	2.2% 2/92 • 3 months	8.2% 7/85 • 3 months
Musculoskeletal and connective tissue disorders Aches	15.2% 14/92 • 3 months	5.9% 5/85 • 3 months
Skin and subcutaneous tissue disorders Rash or pruritus	6.5% 6/92 • 3 months	5.9% 5/85 • 3 months
Reproductive system and breast disorders Sexual	3.3% 3/92 • 3 months	10.6% 9/85 • 3 months

Additional Information

Eric Lenze

Washington University in St. Louis

Phone: 314-362-1671

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60