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

• ClinicalTrials.gov Identifier: NCT00523705
• Recruitment Status: Terminated
• First Posted: August 31, 2007
• Results First Posted: June 6, 2014
• Last Update Posted: June 6, 2014
• Sponsor: University of Pennsylvania
• Collaborator: Forest Laboratories
• Information provided by (Responsible Party): University of Pennsylvania

Tracking Information

• First Submitted Date: August 30, 2007
• First Posted Date: August 31, 2007
• Results First Submitted Date: June 13, 2012
• Results First Posted Date: June 6, 2014
• Last Update Posted Date: June 6, 2014
• Study Start Date: February 2008
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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 (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: Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: PMS

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 19, 2010): 11
• Original Estimated Enrollment (submitted: August 30, 2007): 125
• Actual Study Completion Date: October 2009
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 15 Years to 19 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00523705
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: University of Pennsylvania
• Study Sponsor: University of Pennsylvania
• Collaborators: Forest Laboratories

Investigators

• Principal Investigator: Ellen Freeman; University of Pennsylvania

• PRS Account: University of Pennsylvania
• Verification Date: June 2012