Escitalopram in Patients With Generalized Anxiety Disorder

This study has been completed.

Study NCT00902564 Information provided by H. Lundbeck A/S

First Received on May 14, 2009. Last Updated on May 11, 2011 History of Changes

Results First Received: March 14, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Generalized Anxiety Disorder
Intervention:	Drug: Escitalopram

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Escitalopram (5 to 20 mg Oral Tablets Daily)	No text entered.

Participant Flow: Overall Study

	Escitalopram (5 to 20 mg Oral Tablets Daily)
STARTED	30
COMPLETED	28
NOT COMPLETED	2
Withdrawal by Subject	2

Baseline Characteristics

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Reporting Groups

	Description
Escitalopram (5 to 20 mg Oral Tablets Daily)	No text entered.

Baseline Measures

	Escitalopram (5 to 20 mg Oral Tablets Daily)
Number of Participants [units: participants]	30
Age [units: participants]
<=18 years	0
Between 18 and 65 years	30
>=65 years	0
Age [units: years] Mean ± Standard Deviation	37.3 ± 12
Gender [units: participants]
Female	19
Male	11
Hamilton Anxiety Scale (HAMA) ^[1] [units: scores on a scale] Mean ± Standard Deviation	31.1 ± 5.3
Clinical Global Impression Severity (CGI-S) ^[2] [units: scores on a scale] Mean ± Standard Deviation	4.5 ± 0.6
Sheehan Disability Scale (SDS) Work ^[3] [units: scores on a scale] Mean ± Standard Deviation	6.8 ± 1.6
Sheehan Disability Scale (SDS) Family ^[3] [units: scores on a scale] Mean ± Standard Deviation	6.1 ± 2.0
Sheehan Disability Scale (SDS) Social ^[3] [units: scores on a scale] Mean ± Standard Deviation	6.8 ± 2.5

[1]	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.
[2]	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).
[3]	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

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1. Primary:

Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA) [ Time Frame: baseline and 8 weeks ]

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2. Secondary:

Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I) [ Time Frame: baseline and 8 weeks ]

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3. Secondary:

Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S) [ Time Frame: baseline and 8 weeks ]

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4. Secondary:

Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2 [ Time Frame: baseline and 8 weeks ]

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5. Secondary:

Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2 [ Time Frame: baseline and 8 weeks ]

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6. Secondary:

Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work [ Time Frame: baseline and 8 weeks ]

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7. Secondary:

Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Family [ Time Frame: baseline and 8 weeks ]

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8. Secondary:

Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Social [ Time Frame: baseline and 8 weeks ]

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9. Secondary:

Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score [ Time Frame: baseline and 8 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: H. Lundbeck A/S
phone: Email contact via ext Lundbeck
e-mail: LundbeckClinicalTrials@lundbeck.com

No publications provided

Responsible Party:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT00902564 History of Changes
Other Study ID Numbers:	12132A
Study First Received:	May 14, 2009
Results First Received:	March 14, 2011
Last Updated:	May 11, 2011
Health Authority:	Russia: Ministry of Health and Social Development of the Russian Federation