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

PMS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00523705
• Other study ID #: 805778
• Secondary ID: LXP-MD-123 (Fore
• Status: Terminated
• Phase: Phase 4
• First received: August 30, 2007
• Last updated: May 29, 2014
• Start date: February 2008
• Est. completion date: October 2009

Study information

• Verified date: June 2012
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 19 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• PMS
• Premenstrual Syndrome

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:
• placebo
Placebo tablets matched to drug

Locations

Country	Name	City	State
United States	Dept OB/GYN, Mudd Professorship Suite	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Forest Laboratories

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Sheehan Disability Scale (SDS)		Throughout study	No
Secondary	Patient Global Evaluation of Improvement (PGE)		Throughout treatment	No
Secondary	Subject Satisfaction Questionnaire		Study endpoint	No