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

This study has been terminated.
(Enrollment too slow.)
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00523705
First received: August 30, 2007
Last updated: May 29, 2014
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
PMS
Drug: escitalopram
Other: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Subject Daily Symptom Rating Score. [ Time Frame: baseline and 5 months. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Sheehan Disability Scale (SDS) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Patient Global Evaluation of Improvement (PGE) [ Time Frame: Throughout treatment ] [ Designated as safety issue: No ]
  • Subject Satisfaction Questionnaire [ Time Frame: Study endpoint ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: February 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Placebo Comparator: placebo
Placebo tablets matched to drug.
Other: placebo
Placebo tablets matched to drug

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

Ages Eligible for Study:   15 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523705

Locations
United States, Pennsylvania
Dept OB/GYN, Mudd Professorship Suite
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Forest Laboratories
Investigators
Principal Investigator: Ellen Freeman University of Pennsylvania
  More Information

Publications:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00523705     History of Changes
Other Study ID Numbers: 805778, LXP-MD-123 (Forest Pharm), LXP-MD-123
Study First Received: August 30, 2007
Results First Received: June 13, 2012
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
premenstrual syndrome
PMS
PMDD
treatment
SSRI

Additional relevant MeSH terms:
Premenstrual Syndrome
Syndrome
Disease
Menstruation Disturbances
Pathologic Processes
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014