Escitalopram in Patients With Generalized Anxiety Disorder
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00902564 |
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Recruitment Status :
Completed
First Posted : May 15, 2009
Results First Posted : June 10, 2011
Last Update Posted : June 10, 2011
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Sponsor:
H. Lundbeck A/S
Information provided by:
H. Lundbeck A/S
- Study Details
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- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Generalized Anxiety Disorder |
| Intervention |
Drug: Escitalopram |
| Enrollment | 30 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Escitalopram (5 to 20 mg Oral Tablets Daily) |
|---|---|
 Arm/Group Description |
[Not Specified] |
| Period Title: Overall Study | |
| Started | 30 |
| Completed | 28 |
| Not Completed | 2 |
| Reason Not Completed | |
| Withdrawal by Subject | 2 |
Baseline Characteristics
| Arm/Group Title | Escitalopram (5 to 20 mg Oral Tablets Daily) | |
|---|---|---|
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Arm/Group Description |
[Not Specified] | |
| Overall Number of Baseline Participants | 30 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 30 participants | |
| <=18 years |
0 0.0%
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| Between 18 and 65 years |
30 100.0%
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| >=65 years |
0 0.0%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 30 participants | |
| 37.3 (12) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 30 participants | |
| Female |
19 63.3%
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| Male |
11 36.7%
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Hamilton Anxiety Scale (HAMA)
[1] Mean (Standard Deviation) Unit of measure: Scores on a scale |
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| Number Analyzed | 30 participants | |
| 31.1 (5.3) | ||
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[1]
Measure Description: 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.
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Clinical Global Impression Severity (CGI-S)
[1] Mean (Standard Deviation) Unit of measure: Scores on a scale |
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| Number Analyzed | 30 participants | |
| 4.5 (0.6) | ||
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[1]
Measure Description: 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).
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Sheehan Disability Scale (SDS) Work
[1] Mean (Standard Deviation) Unit of measure: Scores on a scale |
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| Number Analyzed | 30 participants | |
| 6.8 (1.6) | ||
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[1]
Measure Description: 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.
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Sheehan Disability Scale (SDS) Family
[1] Mean (Standard Deviation) Unit of measure: Scores on a scale |
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| Number Analyzed | 30 participants | |
| 6.1 (2.0) | ||
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[1]
Measure Description: 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.
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Sheehan Disability Scale (SDS) Social
[1] Mean (Standard Deviation) Unit of measure: Scores on a scale |
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| Number Analyzed | 30 participants | |
| 6.8 (2.5) | ||
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[1]
Measure Description: 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.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
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.
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | H. Lundbeck A/S |
| Phone: | Email contact via ext Lundbeck |
| EMail: | LundbeckClinicalTrials@lundbeck.com |
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT00902564 |
| Other Study ID Numbers: |
12132A |
| First Submitted: | May 14, 2009 |
| First Posted: | May 15, 2009 |
| Results First Submitted: | March 14, 2011 |
| Results First Posted: | June 10, 2011 |
| Last Update Posted: | June 10, 2011 |