Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT00523705|
Recruitment Status : Terminated (Enrollment too slow.)
First Posted : August 31, 2007
Results First Posted : June 6, 2014
Last Update Posted : June 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|PMS||Drug: escitalopram Other: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
Other Name: Lexapro
Placebo Comparator: placebo
Placebo tablets matched to drug.
Placebo tablets matched to drug
- Subject Daily Symptom Rating Score. [ Time Frame: baseline and 5 months. ]A daily diary with 17 symptoms of PMS rated on a 5-point scale to indicate none to very severe symptoms. Minimum score 0; maximum score 408.
- Sheehan Disability Scale (SDS) [ Time Frame: Throughout study ]
- Patient Global Evaluation of Improvement (PGE) [ Time Frame: Throughout treatment ]
- Subject Satisfaction Questionnaire [ Time Frame: Study endpoint ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523705
|United States, Pennsylvania|
|Dept OB/GYN, Mudd Professorship Suite|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Ellen Freeman||University of Pennsylvania|