Trial Outcomes & Findings for Escitalopram in Patients With Social Anxiety Disorder (NCT NCT00902226)

NCT ID: NCT00902226

Last Updated: 2011-06-10

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: baseline and 12 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	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Escitalopram in Patients With Social 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	36.3 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
CGI Severity Score	4.3 scores on a scale STANDARD_DEVIATION 1.0 • n=5 Participants
Sheehan Disability Scale (SDS) Work	6.9 scores on a scale STANDARD_DEVIATION 1.5 • n=5 Participants
Sheehan Disability Scale (SDS) Family	4.3 scores on a scale STANDARD_DEVIATION 2.1 • n=5 Participants
Sheehan Disability Scale (SDS) Social	7.0 scores on a scale STANDARD_DEVIATION 1.5 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 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=30 Participants
Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I)	2.1 scores on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: baseline and 12 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=30 Participants
Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S)	2.6 scores on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: baseline and 12 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=30 Participants
Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2	80 percentage of patients

SECONDARY outcome

Timeframe: baseline and 12 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=30 Participants
Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2	60 percentage of patients

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: Due to data being unavailable, 22 participants were analysed for this outcome, in contrast with 30 participants for the other outcomes.

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 scales, on which 0 = normal functioning and 10 = severe functional impairment.

Outcome measures

Measure	Escitalopram (5 to 20 mg Oral Tablets Daily) n=22 Participants
Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work	3.8 scores on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: baseline and 12 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 scales, on which 0 = normal functioning and 10 = severe functional impairment.

Outcome measures

Measure	Escitalopram (5 to 20 mg Oral Tablets Daily) n=30 Participants
Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family	2.2 scores on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: baseline and 12 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 scales, on which 0 = normal functioning and 10 = severe functional impairment.

Outcome measures

Measure	Escitalopram (5 to 20 mg Oral Tablets Daily) n=30 Participants
Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social	3.5 scores on a scale Standard Deviation 2.1

Adverse Events

Escitalopram (5 to 20 mg Oral Tablets Daily)

Serious events: 0 serious events

Other events: 16 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 Diarrhoea	6.7% 2/30
Gastrointestinal disorders Nausea	10.0% 3/30
Nervous system disorders Dizziness	6.7% 2/30
Nervous system disorders Headache	6.7% 2/30
Nervous system disorders Muscle spasticity	6.7% 2/30
Psychiatric disorders Anxiety	6.7% 2/30
Psychiatric disorders Insomnia	10.0% 3/30

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 / intellectual property rights. The Investigator shall send any manuscript / 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 / public presentation for an additional 3 months.
• Publication restrictions are in place

Restriction type: OTHER