Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study

This study has been terminated.
(Enrollment too slow.)
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00523705
First received: August 30, 2007
Last updated: May 29, 2014
Last verified: June 2012
Results First Received: June 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: PMS
Interventions: Drug: escitalopram
Other: placebo

  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
The recruitment period was from 01/25/08 to 07/07/09. The study was conducted in an academic research unit. 54 females signed consent for the study at visit 1. 43 were ineligible during the screen period and 11 were randomized to double-blind treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During the screen period of 2 menstrual cycles, subjects rated daily symptom diaries to indicate the presence and severity of premenstrual symptoms. A total premenstrual score >80 in each cycle was required for randomization.

Reporting Groups
  Description
Escitalopram 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.
Sugar Pill Placebo tablets matched to drug.

Participant Flow:   Overall Study
    Escitalopram     Sugar Pill  
STARTED     7     4  
COMPLETED     7     3 [1]
NOT COMPLETED     0     1  
No time for study.                 0                 1  
[1] 1 withdrew due to no time



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Escitalopram 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.
Sugar Pill Placebo tablets matched to drug.
Total Total of all reporting groups

Baseline Measures
    Escitalopram     Sugar Pill     Total  
Number of Participants  
[units: participants]
  7     4     11  
Age  
[units: participants]
     
<=18 years     7     4     11  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  17.6  ± 1.4     17.3  ± 1.3     17.4  ± 1.4  
Gender  
[units: participants]
     
Female     7     4     11  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     7     4     11  



  Outcome Measures
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1.  Primary:   Subject Daily Symptom Rating Score.   [ Time Frame: baseline and 5 months. ]

2.  Secondary:   Sheehan Disability Scale (SDS)   [ Time Frame: Throughout study ]

3.  Secondary:   Patient Global Evaluation of Improvement (PGE)   [ Time Frame: Throughout treatment ]

4.  Secondary:   Subject Satisfaction Questionnaire   [ Time Frame: Study endpoint ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Ellen Freeman, Principal Investigator
Organization: University of Pennsylvania
phone: 215 662-3329
e-mail: freemane@mail.med.upenn.edu


Publications:

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00523705     History of Changes
Other Study ID Numbers: 805778, LXP-MD-123 (Forest Pharm), LXP-MD-123
Study First Received: August 30, 2007
Results First Received: June 13, 2012
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration