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

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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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.
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Other: placebo
Placebo tablets matched to drug |
- 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.
- Sheehan Disability Scale (SDS) [ Time Frame: Throughout study ]
- Patient Global Evaluation of Improvement (PGE) [ Time Frame: Throughout treatment ]
- 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 |
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.

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
United States, Pennsylvania | |
Dept OB/GYN, Mudd Professorship Suite | |
Philadelphia, Pennsylvania, United States, 19104 |
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 |
premenstrual syndrome PMS PMDD treatment SSRI |
Dexetimide Citalopram Premenstrual Syndrome Pathologic Processes Menstruation Disturbances 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 |