Trial Outcomes & Findings for Cognitive-Behavioral Therapy and Escitalopram for Generalized Anxiety Disorder(GAD) (NCT NCT00219349)

NCT ID: NCT00219349

Last Updated: 2017-12-19

Results Overview

The Hamilton Anxiety Rating Scale is a clinician administered rating scale assessing severity of anxiety from 0 (low) to 64 (high). The greater the magnitude of decrease in score during treatment, the greater the improvement in anxiety.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 25 participants
• Primary outcome timeframe: week 14 to week 26
• Results posted on: 2017-12-19

Participant Flow

Participant milestones

Measure	Cognitive-behavioral Therapy 14 weekly sessions of individual cognitive-behavioral therapy
Cognitive Behavioral Therapy Phase STARTED	25
Cognitive Behavioral Therapy Phase COMPLETED	15
Cognitive Behavioral Therapy Phase NOT COMPLETED	10
Escitalopram Phase STARTED	7
Escitalopram Phase COMPLETED	4
Escitalopram Phase NOT COMPLETED	3

Reasons for withdrawal

Measure	Cognitive-behavioral Therapy 14 weekly sessions of individual cognitive-behavioral therapy
Cognitive Behavioral Therapy Phase Lost to Follow-up	6
Cognitive Behavioral Therapy Phase Withdrawal by Subject	2
Cognitive Behavioral Therapy Phase Protocol Violation	2
Escitalopram Phase Withdrawal by Subject	3

Baseline Characteristics

Cognitive-Behavioral Therapy and Escitalopram for Generalized Anxiety Disorder(GAD)

Baseline characteristics by cohort

Measure	Cognitive-behavioral Therapy n=25 Participants 14 weekly sessions of individual cognitive-behavioral therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: week 14 to week 26

Population: see above: Patients who completed the CBT phase and started escitalopram treatment

The Hamilton Anxiety Rating Scale is a clinician administered rating scale assessing severity of anxiety from 0 (low) to 64 (high). The greater the magnitude of decrease in score during treatment, the greater the improvement in anxiety.

Outcome measures

Measure	Patients Who Started Escitalopram n=7 Participants Patients who completed the CBT phase and started escitalopram phase treatment
Change in Hamilton Anxiety Rating Scale Score	-6.4 units on a scale Standard Deviation 10.1

PRIMARY outcome

Timeframe: week 14 to week 26

7 point scale of overall severity of psychopathology from 1 mildest to 7 most severe.

Outcome measures

Measure	Patients Who Started Escitalopram n=7 Participants Patients who completed the CBT phase and started escitalopram phase treatment
Change in Clinical Global Impressions-Severity Index	1.4 units on a scale Standard Deviation 1.0

PRIMARY outcome

Timeframe: week 14 to week 26

measures severity of symptoms of generalized anxiety disorder, reported as a total score summing 10 items that are each rated from 0, never to 4, all of the time. Range is 0 to 40, with 40 most severe.

Outcome measures

Measure	Patients Who Started Escitalopram n=7 Participants Patients who completed the CBT phase and started escitalopram phase treatment
Change in Generalized Anxiety Disorder Severity Scale	4.8 units on a scale Standard Deviation 3.2

PRIMARY outcome

Timeframe: week 14 to week 26

total score (of 16 items) ranging from 16 (least worry) to 80 (most worry)

Outcome measures

Measure	Patients Who Started Escitalopram n=7 Participants Patients who completed the CBT phase and started escitalopram phase treatment
Change in Penn State Worry Questionnaire	9.8 units on a scale Standard Deviation 11.2

PRIMARY outcome

Timeframe: week 14 to week 26

only the total score of the state anxiey subscale was used. Range is from 20 (mildest) to 80 (most severe)

Outcome measures

Measure	Patients Who Started Escitalopram n=7 Participants Patients who completed the CBT phase and started escitalopram phase treatment
Change in State-Trait Anxiety Inventory, State Subscale	15.4 units on a scale Standard Deviation 11.6

SECONDARY outcome

Timeframe: week 26

This is a single item rating overall symptomatic improvement. Range is 0 (very much worse) to 7 (very much improved)

Outcome measures

Measure	Patients Who Started Escitalopram n=7 Participants Patients who completed the CBT phase and started escitalopram phase treatment
Clinical Global Impressions-Improvement Index	3.0 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: week 14 to week 26

24 item version of this standard depression scale, total score ranges from 0 (not depressed) to 58 (most severe)

Outcome measures

Measure	Patients Who Started Escitalopram n=7 Participants Patients who completed the CBT phase and started escitalopram phase treatment
Change in Hamilton Rating Scale for Depression	7.3 units on a scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: week 14 to week 26

total score ranges from 0 (not depressed) to 63 (most severe)

Outcome measures

Measure	Patients Who Started Escitalopram n=7 Participants Patients who completed the CBT phase and started escitalopram phase treatment
Change in Beck Depression Inventory-II	10.7 units on a scale Standard Deviation 10.3

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group 1 n=25 participants at risk all subject entered
Nervous system disorders insomnia	8.0% 2/25 • Number of events 5 • 6 months

Additional Information

Franklin Schneier MD

New York State Psychiatric Institute

Phone: 2125435368

Email: fschneier@nyspi.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place