Clinical trial NCT00523705: Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
Official title: Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: PMS
Keywords: premenstrual syndrome
PMS
PMDD
treatment
SSRI
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2007-08-31
Enrollment: 11
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Subject Daily Symptom Rating Score.
timeFrame: baseline and 5 months.
Secondary outcomes:
measure: Sheehan Disability Scale (SDS)
timeFrame: Throughout study
measure: Patient Global Evaluation of Improvement (PGE)
timeFrame: Throughout treatment
measure: Subject Satisfaction Questionnaire
timeFrame: Study endpoint
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Dept OB/GYN, Mudd Professorship Suite
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ellen Freeman
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.jpag.2006.06.015.