- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00523705
Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
May 29, 2014 updated by: University of Pennsylvania
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.
Study Overview
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
Enrollment (Actual)
11
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Dept OB/GYN, Mudd Professorship Suite
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
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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 Names:
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Placebo Comparator: placebo
Placebo tablets matched to drug.
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Placebo tablets matched to drug
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Daily Symptom Rating Score.
Time Frame: baseline and 5 months.
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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.
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baseline and 5 months.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sheehan Disability Scale (SDS)
Time Frame: Throughout study
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Throughout study
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Patient Global Evaluation of Improvement (PGE)
Time Frame: Throughout treatment
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Throughout treatment
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Subject Satisfaction Questionnaire
Time Frame: Study endpoint
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Study endpoint
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ellen Freeman, University of Pennsylvania
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
August 30, 2007
First Submitted That Met QC Criteria
August 30, 2007
First Posted (Estimate)
August 31, 2007
Study Record Updates
Last Update Posted (Estimate)
June 6, 2014
Last Update Submitted That Met QC Criteria
May 29, 2014
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Menstruation Disturbances
- Premenstrual Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- 805778
- LXP-MD-123 (Forest Pharm) (Other Identifier: Forest Research Institute)
- LXP-MD-123 (Other Identifier: Forest Research Institute)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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