Trial Outcomes & Findings for Antidepressant Treatment Plus Cognitive Behavioral Therapy for Generalized Anxiety Disorder in Older Adults (NCT NCT00601965)

NCT ID: NCT00601965

Last Updated: 2016-08-25

Results Overview

The Hamilton Anxiety Rating Scale is a clinician-rated measure of cognitive and somatic anxiety symptoms. It consists of 14 items, each of which is scored on a 0-4 scale, summed for a total score ranging from 0 to 56. Inclusion criteria for this study included a Hamilton score \>= 17. The Hamilton, administered by blind raters, will be used to test hypotheses number 1 and 2. The outcome of interest is the number of participants who relapse, defined as having a Hamilton increase of \>=5, for a total Hamilton \>=14, relative to the end of the continuation phase (week 28), for a duration of at least 2 weeks, plus both clinician's and participant's judgment that the participant is experiencing a recurrence of anxiety symptoms. HAMA scores range from 0 (no anxiety) to 56 (high anxiety).

Recruitment status

COMPLETED

Study phase

Target enrollment

73 participants

Primary outcome timeframe

56 weeks

Results posted on

2016-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	Escitalopram + CBT 12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram Escitalopram: 20 mg daily oral escitalopram Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions	Escitalopram + no CBT 12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram Escitalopram: 20 mg daily oral escitalopram	Placebo + CBT 12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo Escitalopram: 20 mg daily oral escitalopram Placebo: Placebo pill of daily oral escitalopram Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions	Placebo + no CBT 12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo Escitalopram: 20 mg daily oral escitalopram Placebo: Placebo pill of daily oral escitalopram
Overall Study STARTED	18	18	19	18
Overall Study COMPLETED	18	16	19	17
Overall Study NOT COMPLETED	0	2	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antidepressant Treatment Plus Cognitive Behavioral Therapy for Generalized Anxiety Disorder in Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Escitalopram + CBT n=18 Participants 12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram Escitalopram: 20 mg daily oral escitalopram Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions	Escitalopram + no CBT n=18 Participants 12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram Escitalopram: 20 mg daily oral escitalopram	Placebo + CBT n=19 Participants 12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo Escitalopram: 20 mg daily oral escitalopram Placebo: Placebo pill of daily oral escitalopram Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions	Placebo + no CBT n=18 Participants 12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo Escitalopram: 20 mg daily oral escitalopram Placebo: Placebo pill of daily oral escitalopram	Total n=73 Participants Total of all reporting groups
Age, Continuous	70.5 years STANDARD_DEVIATION 7.7 • n=5 Participants	70.3 years STANDARD_DEVIATION 8.6 • n=7 Participants	70.2 years STANDARD_DEVIATION 8.1 • n=5 Participants	66.9 years STANDARD_DEVIATION 5.7 • n=4 Participants	69.5 years STANDARD_DEVIATION 7.5 • n=21 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	6 Participants n=4 Participants	27 Participants n=21 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	12 Participants n=4 Participants	46 Participants n=21 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants	13 Participants n=4 Participants	52 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	21 Participants n=21 Participants
Race/Ethnicity, Customized Caucasian	13 participants n=5 Participants	13 participants n=7 Participants	16 participants n=5 Participants	15 participants n=4 Participants	57 participants n=21 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	5 participants n=21 Participants
Race/Ethnicity, Customized African American	4 participants n=5 Participants	4 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	10 participants n=21 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Region of Enrollment United States	18 participants n=5 Participants	18 participants n=7 Participants	19 participants n=5 Participants	18 participants n=4 Participants	73 participants n=21 Participants

PRIMARY outcome

Timeframe: 56 weeks

Outcome measures

Outcome measures
Measure	Escitalopram + CBT n=18 Participants 12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram Escitalopram: 20 mg daily oral escitalopram Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions	Escitalopram + no CBT n=16 Participants 12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram Escitalopram: 20 mg daily oral escitalopram	Placebo + CBT n=19 Participants 12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo Escitalopram: 20 mg daily oral escitalopram Placebo: Placebo pill of daily oral escitalopram Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions	Placebo + no CBT n=17 Participants 12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo Escitalopram: 20 mg daily oral escitalopram Placebo: Placebo pill of daily oral escitalopram
Hamilton Anxiety Rating Scale	18 participants	15 participants	14 participants	8 participants

PRIMARY outcome

Timeframe: 56 weeks

The Penn State Worry Questionnaire is a 16-item measure of pathological worry. Scores range from 16-80, with higher scores indicating higher levels of worry.

Outcome measures

Outcome measures
Measure	Escitalopram + CBT n=18 Participants 12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram Escitalopram: 20 mg daily oral escitalopram Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions	Escitalopram + no CBT n=19 Participants 12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram Escitalopram: 20 mg daily oral escitalopram	Placebo + CBT n=18 Participants 12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo Escitalopram: 20 mg daily oral escitalopram Placebo: Placebo pill of daily oral escitalopram Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions	Placebo + no CBT n=18 Participants 12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo Escitalopram: 20 mg daily oral escitalopram Placebo: Placebo pill of daily oral escitalopram
Penn State Worry Questionnaire	52.8 units on a scale Standard Deviation 2.6	53.4 units on a scale Standard Deviation 10.3	54.4 units on a scale Standard Deviation 11.7	57.7 units on a scale Standard Deviation 12.7

Adverse Events

Escitalopram + CBT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Escitalopram + no CBT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo + CBT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo + no CBT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Julie Wetherell

Veterans Medical Research Foundation

Phone: 858-552-8585

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place