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

Study Overview
=================
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.

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

Conditions
-----------------
PMS

Intervention / Treatment
-----------------
* Drug: escitalopram
* Other: placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: escitalopram<br>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. | Drug: escitalopram<br>* 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.<br>* Other names: Lexapro;|
| Placebo Comparator: placebo<br>Placebo tablets matched to drug. | Other: placebo<br>* Placebo tablets matched to drug<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Daily Symptom Rating Score. | 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. | baseline and 5 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sheehan Disability Scale (SDS) |  | Throughout study | 
| Patient Global Evaluation of Improvement (PGE) |  | Throughout treatment | 
| Subject Satisfaction Questionnaire |  | Study endpoint | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
premenstrual syndrome, PMS, PMDD, treatment, SSRI