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

Primary Purpose

PMS

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
escitalopram
placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PMS focused on measuring premenstrual syndrome, PMS, PMDD, treatment, SSRI

Eligibility Criteria

15 Years - 19 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Dept OB/GYN, Mudd Professorship Suite

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

escitalopram

placebo

Arm Description

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.

Placebo tablets matched to drug.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sheehan Disability Scale (SDS)
Patient Global Evaluation of Improvement (PGE)
Subject Satisfaction Questionnaire

Full Information

First Posted
August 30, 2007
Last Updated
May 29, 2014
Sponsor
University of Pennsylvania
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00523705
Brief Title
Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
Official Title
Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Enrollment too slow.
Study Start Date
February 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PMS
Keywords
premenstrual syndrome, PMS, PMDD, treatment, SSRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
escitalopram
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets matched to drug.
Intervention Type
Drug
Intervention Name(s)
escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Placebo tablets matched to drug
Primary Outcome Measure Information:
Title
Subject Daily Symptom Rating Score.
Description
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.
Time Frame
baseline and 5 months.
Secondary Outcome Measure Information:
Title
Sheehan Disability Scale (SDS)
Time Frame
Throughout study
Title
Patient Global Evaluation of Improvement (PGE)
Time Frame
Throughout treatment
Title
Subject Satisfaction Questionnaire
Time Frame
Study endpoint

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Freeman
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept OB/GYN, Mudd Professorship Suite
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17174829
Citation
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.
Results Reference
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Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study

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