Trial Outcomes & Findings for Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly (NCT NCT00701675)

Last Updated: 2016-12-29

Results Overview

Least squares (LS) means estimate and p-value from mixed effects model with baseline and site as covariates and Tukey-Kramer adjustment for multiple comparisons Hamilton Rating Scale for Anxiety (HAM-A) is a widely used rating scale for anxiety describes the presence/absence of the severity of anxiety symptoms. It's clinician-rated scale of 14 items rated from 0-4. Generally, total score of \<17 is mild anxiety; 18-24 is mild to moderate, and 25 and up is moderate to severe.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

42 participants

Primary outcome timeframe

11 weeks from baseline

Results posted on

2016-12-29

Participant Flow

Participant milestones

Participant milestones
Measure	Sertraline 50mg sertraline 50mg per day sertraline 50 mg daily: 50 mg daily	Sertraline 100mg sertraline 100mg per day sertraline 100 mg daily: 100 mg daily	Placebo matching placebo Placebo 50 or 100 mg: matching placebo
Overall Study STARTED	14	14	14
Overall Study COMPLETED	10	6	7
Overall Study NOT COMPLETED	4	8	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sertraline 50mg n=14 Participants sertraline 50mg per day sertraline 50 mg daily: 50 mg daily	Sertraline 100mg n=14 Participants sertraline 100mg per day sertraline 100 mg daily: 100 mg daily	Placebo n=14 Participants matching placebo Placebo 50 or 100 mg: matching placebo	Total n=42 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	26 Participants n=4 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Gender Female	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Gender Male	13 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	41 Participants n=4 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	14 participants n=5 Participants	42 participants n=4 Participants

PRIMARY outcome

Timeframe: 11 weeks from baseline

Population: sertraline 50mg group and placebo group each had 2 subjects with missing data.

Outcome measures

Outcome measures
Measure	Sertraline 50mg n=14 Participants sertraline 50mg per day sertraline 50 mg daily: 50 mg daily	Sertraline 100mg n=12 Participants sertraline 100mg per day sertraline 100 mg daily: 100 mg daily	Placebo n=12 Participants matching placebo Placebo 50 or 100 mg: matching placebo
Comparisons of End of Study HAM-A Score Means for Sertraline 50 mg vs Placebo, Sertraline 100 mg vs Placebo, and Sertraline 50 mg vs. Sertraline 100 mg	10.638 units on a scale Interval 7.456 to 13.819	10.008 units on a scale Interval 5.692 to 14.323	9.357 units on a scale Interval 5.159 to 13.554

Adverse Events

Sertraline 50mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Sertraline 100mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sertraline 50mg n=14 participants at risk sertraline 50mg per day sertraline 50 mg daily: 50 mg daily	Sertraline 100mg n=14 participants at risk sertraline 100mg per day sertraline 100 mg daily: 100 mg daily	Placebo n=14 participants at risk matching placebo Placebo 50 or 100 mg: matching placebo
Nervous system disorders jitteriness	7.1% 1/14 • Number of events 1 • weeks 1,2,3,5,7,9,and 11	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11
Nervous system disorders agitation	7.1% 1/14 • Number of events 1 • weeks 1,2,3,5,7,9,and 11	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11
Surgical and medical procedures oral surgery	7.1% 1/14 • Number of events 1 • weeks 1,2,3,5,7,9,and 11	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11
Gastrointestinal disorders nausea	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11	7.1% 1/14 • Number of events 1 • weeks 1,2,3,5,7,9,and 11	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11
Respiratory, thoracic and mediastinal disorders sinusitis	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11	7.1% 1/14 • Number of events 1 • weeks 1,2,3,5,7,9,and 11	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11
Nervous system disorders tremor	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11	7.1% 1/14 • Number of events 1 • weeks 1,2,3,5,7,9,and 11	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11
Respiratory, thoracic and mediastinal disorders shortness of breath	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11	7.1% 1/14 • Number of events 1 • weeks 1,2,3,5,7,9,and 11	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11
General disorders dry mouth	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11	7.1% 1/14 • Number of events 1 • weeks 1,2,3,5,7,9,and 11
Nervous system disorders drowsiness	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11	7.1% 1/14 • Number of events 1 • weeks 1,2,3,5,7,9,and 11
Nervous system disorders dizziness	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11	0.00% 0/14 • weeks 1,2,3,5,7,9,and 11	7.1% 1/14 • Number of events 1 • weeks 1,2,3,5,7,9,and 11

Additional Information

Olga Brawman-Mintzer, MD

Ralp H. Johnson VA Medical Center

Phone: 8437242302

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place