Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT00523705
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
15 Years
Maximum Age:
19 Years
Study:
NCT00523705
Study Brief:
Protocol Section:
NCT00523705