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

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ClinicalTrials.gov Identifier: NCT00523705
Recruitment Status : Terminated (Enrollment too slow.)
First Posted : August 31, 2007
Results First Posted : June 6, 2014
Last Update Posted : June 6, 2014
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
PMS Drug: escitalopram Other: placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
Study Start Date : February 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Subject Daily Symptom Rating Score. [ Time Frame: baseline and 5 months. ]
    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 :
  1. Sheehan Disability Scale (SDS) [ Time Frame: Throughout study ]
  2. Patient Global Evaluation of Improvement (PGE) [ Time Frame: Throughout treatment ]
  3. Subject Satisfaction Questionnaire [ Time Frame: Study endpoint ]


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Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00523705     History of Changes
Other Study ID Numbers: 805778
LXP-MD-123 (Forest Pharm) ( Other Identifier: Forest Research Institute )
LXP-MD-123 ( Other Identifier: Forest Research Institute )
First Posted: August 31, 2007    Key Record Dates
Results First Posted: June 6, 2014
Last Update Posted: June 6, 2014
Last Verified: June 2012

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

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