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

August 30, 2007
May 29, 2014
February 2008
October 2009   (final data collection date for primary outcome measure)
Subject Daily Symptom Rating Score. [ Time Frame: baseline and 5 months. ] [ Designated as safety issue: No ]
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.
  • Subject daily symptom rating score. [ Time Frame: Throughout study (~5 months). ]
  • Clinician global impressions (CGI score). [ Time Frame: Throughout study ]
Complete list of historical versions of study NCT00523705 on ClinicalTrials.gov Archive Site
  • Sheehan Disability Scale (SDS) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Patient Global Evaluation of Improvement (PGE) [ Time Frame: Throughout treatment ] [ Designated as safety issue: No ]
  • Subject Satisfaction Questionnaire [ Time Frame: Study endpoint ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
PMS
  • 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
  • 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
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.
 
Terminated
11
October 2009
October 2009   (final data collection date for primary outcome measure)

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.
Female
15 Years to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00523705
805778, LXP-MD-123 (Forest Pharm), LXP-MD-123
No
University of Pennsylvania
University of Pennsylvania
Forest Laboratories
Principal Investigator: Ellen Freeman University of Pennsylvania
University of Pennsylvania
June 2012

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