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Trial record 55 of 590 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

Tracking Information
First Submitted Date  ICMJE August 30, 2007
First Posted Date  ICMJE August 31, 2007
Results First Submitted Date  ICMJE June 13, 2012
Results First Posted Date  ICMJE June 6, 2014
Last Update Posted Date June 6, 2014
Study Start Date  ICMJE February 2008
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2007)
  • Subject Daily Symptom Rating Score. [ Time Frame: Throughout study (~5 months). ]
  • Clinician global impressions (CGI score). [ Time Frame: Throughout study ]
Change History Complete list of historical versions of study NCT00523705 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2007)
  • Sheehan Disability Scale (SDS) [ Time Frame: Throughout study ]
  • Steiner Premenstrual Tension Scale (PMTS) [ Time Frame: Throughout study ]
  • Patient Global Evaluation of Improvement (PGE) [ Time Frame: Throughout treatment ]
  • Subject Satisfaction Questionnaire [ Time Frame: Study endpoint ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
Official Title  ICMJE Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
Brief Summary The purpose of this pilot study is to determine the efficacy and safety of escitalopram administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe PMS in young women ages 15-19 years.
Detailed Description The medication in this study is a serotonin reuptake inhibitor (SSRI), a class that is considered the first-line treatment for severe PMS at this time. Although data indicate that young women who have PMS in their teen years report the same symptoms and symptom severity as adult women, clinical trials have not included this age group, and there is no information on the efficacy and safety of treatment with a serotonergic antidepressant for PMS in teens.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE PMS
Intervention  ICMJE
  • Drug: 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.
    Other Name: Lexapro
  • Other: placebo
    Placebo tablets matched to drug
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: escitalopram
  • Placebo Comparator: placebo
    Placebo tablets matched to drug.
    Intervention: Other: placebo
Publications * Vichnin M, Freeman EW, Lin H, Hillman J, Bui S. Premenstrual syndrome (PMS) in adolescents: severity and impairment. J Pediatr Adolesc Gynecol. 2006 Dec;19(6):397-402.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 19, 2010)
11
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2007)
125
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Females 15-19 years of age
  • Regular menstrual cycles of 22-35 days
  • In general good health
  • Medically approved birth control method if sexually active
  • Evidence of ovulation
  • Meeting all symptom criteria for PMS
  • Signed informed consent
  • Subjects under age 18 must also have signed parental consent

Exclusion Criteria:

  • Current use of any treatment for PMS.
  • Psychotropic or other medications that may compromise the study drug.
  • Pregnancy, intending pregnancy or breast feeding.
  • Not using a medically approved birth control method if sexually active.
  • Significant medical or gynecological abnormalities.
  • Irregular menses, any gynecologic disorder.
  • Any severe or unstable medical illness.
  • Any current major psychiatric diagnosis or any history of a major psychiatric diagnosis.
  • Any current or history of alcohol abuse, drug abuse, suicide attempt, bi-polar disorder, psychosis or severe personality disorder.
  • Use of triptans (Imitrex, Zomig, Frova, Maxalt, Axert, Amerge, Relpax).
  • Use of medicines that include dextromethorphan such as Tylenol or Vicks cough medicines.
  • Use of the pain medication meperidine.
  • Use of any herbal product such as St John's Wort that may increase serotonin.
  • Use of monoamine oxidase inhibitors (MAOIs), pimozide or citalopram hydrobromide.
  • Drugs metabolized by CYP2D6 or a combination of CYP3A4 and CYP2D6 inhibitors.
  • Hypersensitivity to escitalopram or citalopram.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00523705
Other Study ID Numbers  ICMJE 805778
LXP-MD-123 (Forest Pharm) ( Other Identifier: Forest Research Institute )
LXP-MD-123 ( Other Identifier: Forest Research Institute )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Principal Investigator: Ellen Freeman University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP