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

NCT00523705 | Terminated Phase 4 Results

• 3 other identifiers: 805778LXP-MD-123 (Forest Pharm)LXP-MD-123
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

PMS

Keywords

premenstrual syndrome; PMS; PMDD; treatment; SSRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sheehan Disability Scale (SDS)

  Throughout study

• Patient Global Evaluation of Improvement (PGE)

  Throughout treatment

• Subject Satisfaction Questionnaire

  Study endpoint

Study Arms (2)

escitalopram

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

Placebo tablets matched to drug.

Other: placebo

Interventions

escitalopram DRUG

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.

Also known as: Lexapro

escitalopram

placebo OTHER

Placebo tablets matched to drug

placebo

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Forest Laboratories: collaborator

Study Sites (1)

Dept OB/GYN, Mudd Professorship Suite

Philadelphia, Pennsylvania, 19104, United States

Location

Related 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. doi: 10.1016/j.jpag.2006.06.015.

  PMID: 17174829 BACKGROUND

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Ellen Freeman, Principal Investigator
• Organization: University of Pennsylvania

freemane@mail.med.upenn.edu

215 662-3329

Study Officials

• Ellen Freeman

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2007
• First Posted: August 31, 2007
• Study Start: February 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 6, 2014
• Results First Posted: June 6, 2014

Record last verified: 2012-06

Locations

US (1)