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Trial record 56 of 595 for:    ESCITALOPRAM AND Celexa

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
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition PMS
Interventions Drug: escitalopram
Other: placebo
Enrollment 11
Recruitment Details 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 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.
Arm/Group Title Escitalopram Sugar Pill
Hide Arm/Group Description 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. Placebo tablets matched to drug.
Period Title: Overall Study
Started 7 4
Completed 7 3 [1]
Not Completed 0 1
Reason Not Completed
No time for study.             0             1
[1]
1 withdrew due to no time
Arm/Group Title Escitalopram Sugar Pill Total
Hide Arm/Group Description 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. Placebo tablets matched to drug. Total of all reporting groups
Overall Number of Baseline Participants 7 4 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 4 participants 11 participants
<=18 years
7
 100.0%
4
 100.0%
11
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 4 participants 11 participants
17.6  (1.4) 17.3  (1.3) 17.4  (1.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 4 participants 11 participants
Female
7
 100.0%
4
 100.0%
11
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 4 participants 11 participants
7 4 11
1.Primary Outcome
Title Subject Daily Symptom Rating Score.
Hide Description 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.
Time Frame baseline and 5 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Sugar Pill
Hide Arm/Group Description:
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.
Placebo tablets matched to drug.
Overall Number of Participants Analyzed 7 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
mean score at baseline 155.6  (55.3) 169  (59.1)
mean score at endpoint (5 months) 91.6  (54.2) 121.3  (131.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram, Sugar Pill
Comments Pilot data were examined at treatment endpoint for change from baseline. Statistical power was very low due to the small sample size.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.467
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.57
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.86
Estimation Comments estimate of main effect of treatment in a linear mixed effects model.
2.Secondary Outcome
Title Sheehan Disability Scale (SDS)
Hide Description [Not Specified]
Time Frame Throughout study
Hide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed due to only 11 subjects.
Arm/Group Title Escitalopram Sugar Pill
Hide Arm/Group Description:
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.
Placebo tablets matched to drug.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Patient Global Evaluation of Improvement (PGE)
Hide Description [Not Specified]
Time Frame Throughout treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Not analyzed due to small number of subjects
Arm/Group Title Escitalopram Sugar Pill
Hide Arm/Group Description:
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.
Placebo tablets matched to drug.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Subject Satisfaction Questionnaire
Hide Description [Not Specified]
Time Frame Study endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Not analyzed due to small number of subjects.
Arm/Group Title Escitalopram Sugar Pill
Hide Arm/Group Description:
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.
Placebo tablets matched to drug.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 3 treatment months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram Sugar Pill
Hide Arm/Group Description 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. Placebo tablets matched to drug.
All-Cause Mortality
Escitalopram Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Escitalopram Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/7 (71.43%)      0/4 (0.00%)    
Gastrointestinal disorders     
nausea   1/7 (14.29%)  1 0/4 (0.00%)  0
General disorders     
fatigue   3/7 (42.86%)  8 0/4 (0.00%)  0
insomnia   1/7 (14.29%)  1 0/4 (0.00%)  0
other   3/7 (42.86%)  6 0/4 (0.00%)  0
Nervous system disorders     
headache   2/7 (28.57%)  2 0/4 (0.00%)  0
dizziness   1/7 (14.29%)  1 0/4 (0.00%)  0
Reproductive system and breast disorders     
breast tenderness   1/7 (14.29%)  1 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Ellen Freeman, Principal Investigator
Organization: University of Pennsylvania
Phone: 215 662-3329
EMail: freemane@mail.med.upenn.edu
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00523705     History of Changes
Other Study ID Numbers: 805778
LXP-MD-123 (Forest Pharm) ( Other Identifier: Forest Research Institute )
LXP-MD-123 ( Other Identifier: Forest Research Institute )
First Submitted: August 30, 2007
First Posted: August 31, 2007
Results First Submitted: June 13, 2012
Results First Posted: June 6, 2014
Last Update Posted: June 6, 2014