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

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

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.

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

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:

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.

• 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
• 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:

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