PMS
Conditions
Keywords
premenstrual syndrome, PMS, PMDD, treatment, SSRI
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.
Interventions
DRUGescitalopram
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.
OTHERplacebo
Placebo tablets matched to drug
Sponsors
Forest Laboratories
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 19 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Daily Symptom Rating Score. | 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
| Measure | Time frame |
|---|---|
| Sheehan Disability Scale (SDS) | Throughout study |
| Patient Global Evaluation of Improvement (PGE) | Throughout treatment |
| Subject Satisfaction Questionnaire | Study endpoint |
Countries
United States
Participant flow
Recruitment details
The recruitment period was from 01/25/08 to 07/07/09. The study was conducted in an academic research unit. 54 females signed consent for the study at visit 1. 43 were ineligible during the screen period and 11 were randomized to double-blind treatment.
Pre-assignment details
During the screen period of 2 menstrual cycles, subjects rated daily symptom diaries to indicate the presence and severity of premenstrual symptoms. A total premenstrual score \>80 in each cycle was required for randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| Sugar Pill Placebo tablets matched to drug. | 4 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No time for study. | 0 | 1 |
Baseline characteristics
| Characteristic | Sugar Pill | Escitalopram | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 7 Participants | 11 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 17.3 years STANDARD_DEVIATION 1.3 | 17.6 years STANDARD_DEVIATION 1.4 | 17.4 years STANDARD_DEVIATION 1.4 |
| Region of Enrollment United States | 4 participants | 7 participants | 11 participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 7 | 0 / 4 |
| serious Total, serious adverse events | 0 / 7 | 0 / 4 |
Outcome results
Primary
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.
Time frame: baseline and 5 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Escitalopram | Subject Daily Symptom Rating Score. | mean score at baseline | 155.6 units on a scale | Standard Deviation 55.3 |
| Escitalopram | Subject Daily Symptom Rating Score. | mean score at endpoint (5 months) | 91.6 units on a scale | Standard Deviation 54.2 |
| Sugar Pill | Subject Daily Symptom Rating Score. | mean score at baseline | 169 units on a scale | Standard Deviation 59.1 |
| Sugar Pill | Subject Daily Symptom Rating Score. | mean score at endpoint (5 months) | 121.3 units on a scale | Standard Deviation 131.6 |
Comparison: Pilot data were examined at treatment endpoint for change from baseline. Statistical power was very low due to the small sample size.p-value: 0.467Regression, Linear
Secondary
Patient Global Evaluation of Improvement (PGE)
Time frame: Throughout treatment
Population: Not analyzed due to small number of subjects
Secondary
Sheehan Disability Scale (SDS)
Time frame: Throughout study
Population: Data not analyzed due to only 11 subjects.
Secondary
Subject Satisfaction Questionnaire
Time frame: Study endpoint
Population: Not analyzed due to small number of subjects.