Trial Outcomes & Findings for Escitalopram in Patients With Generalized Anxiety Disorder (NCT NCT00902564)

NCT ID: NCT00902564

Last Updated: 2011-06-10

Results Overview

The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: baseline and 8 weeks
• Results posted on: 2011-06-10

Participant Flow

Participant milestones

Measure	Escitalopram (5 to 20 mg Oral Tablets Daily)
Overall Study STARTED	30
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Escitalopram (5 to 20 mg Oral Tablets Daily)
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Escitalopram in Patients With Generalized Anxiety Disorder

Baseline characteristics by cohort

Measure	Escitalopram (5 to 20 mg Oral Tablets Daily) n=30 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	37.3 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Hamilton Anxiety Scale (HAMA)	31.1 scores on a scale STANDARD_DEVIATION 5.3 • n=5 Participants
Clinical Global Impression Severity (CGI-S)	4.5 scores on a scale STANDARD_DEVIATION 0.6 • n=5 Participants
Sheehan Disability Scale (SDS) Work	6.8 scores on a scale STANDARD_DEVIATION 1.6 • n=5 Participants
Sheehan Disability Scale (SDS) Family	6.1 scores on a scale STANDARD_DEVIATION 2.0 • n=5 Participants
Sheehan Disability Scale (SDS) Social	6.8 scores on a scale STANDARD_DEVIATION 2.5 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 8 weeks

The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.

Outcome measures

Measure	Escitalopram (5 to 20 mg Oral Tablets Daily) n=28 Participants
Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)	13.1 scores on a scale Standard Deviation 6.2

SECONDARY outcome

Timeframe: baseline and 8 weeks

The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).

Outcome measures

Measure	Escitalopram (5 to 20 mg Oral Tablets Daily) n=28 Participants
Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I)	1.2 scores on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: baseline and 8 weeks

The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).

Outcome measures

Measure	Escitalopram (5 to 20 mg Oral Tablets Daily) n=28 Participants
Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S)	1.9 scores on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: baseline and 8 weeks

The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).

Outcome measures

Measure	Escitalopram (5 to 20 mg Oral Tablets Daily) n=28 Participants
Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2	100 percentage of patients

SECONDARY outcome

Timeframe: baseline and 8 weeks

The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).

Outcome measures

Measure	Escitalopram (5 to 20 mg Oral Tablets Daily) n=28 Participants
Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2	85.7 percentage of patients

SECONDARY outcome

Timeframe: baseline and 8 weeks

The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.

Outcome measures

Measure	Escitalopram (5 to 20 mg Oral Tablets Daily) n=21 Participants
Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work	2.0 scores on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: baseline and 8 weeks

The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.

Outcome measures

Measure	Escitalopram (5 to 20 mg Oral Tablets Daily) n=28 Participants
Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Family	1.2 scores on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: baseline and 8 weeks

The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.

Outcome measures

Measure	Escitalopram (5 to 20 mg Oral Tablets Daily) n=28 Participants
Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Social	1.7 scores on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: baseline and 8 weeks

Population: Observed Cases (OC)

The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.

Outcome measures

Measure	Escitalopram (5 to 20 mg Oral Tablets Daily) n=28 Participants
Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score	67.9 percentage of patients

Adverse Events

Escitalopram (5 to 20 mg Oral Tablets Daily)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Escitalopram (5 to 20 mg Oral Tablets Daily) n=30 participants at risk
Gastrointestinal disorders Dry mouth	16.7% 5/30 • 8 weeks
Nervous system disorders Headache	6.7% 2/30 • 8 weeks
Psychiatric disorders Anxiety	6.7% 2/30 • 8 weeks
Psychiatric disorders Insomnia	6.7% 2/30 • 8 weeks
Skin and subcutaneous tissue disorders Hyperhidrosis	6.7% 2/30 • 8 weeks

Additional Information

Study Director

H. Lundbeck A/S

Phone: Email contact via

Email: LundbeckClinicalTrials@lundbeck.com

Results disclosure agreements

• Principal investigator is a sponsor employee No results can be made public before appropriate steps by Lundbeck to secure patents and/or intellectual property rights. The Investigator shall send any manuscript and/or public presentation to Lundbeck at least 1 month before submission for publication. If Lundbeck finds matters requiring patents or the like, the Investigator shall delay publication and/or public presentation for an additional 3 months.
• Publication restrictions are in place

Restriction type: OTHER