Overview
Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder
Status:
Completed
Completed
Trial end date:
2012-02-01
2012-02-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
This study will evaluate the effectiveness of sertraline in reducing symptoms in women diagnosed with premenstrual dysphoric disorder.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Yale UniversityCollaborator:
National Institute of Mental Health (NIMH)Treatments:
Sertraline
Criteria
Inclusion Criteria:- Menstruating and has cycles between 21 and 35 days
- Meets DSM-IV criteria for PMDD
- Experienced symptoms of PMDD in at least 9 of 12 menstrual cycles within 1 year of
study entry
- Willing to use an effective form of birth control throughout the study
Exclusion Criteria:
- Meets MINI DSM-IV criteria for major depressive episode, substance abuse, bulimia
nervosa, anorexia, bipolar disorder, or a psychotic disorder, such as schizophrenia or
schizoaffective disorder, within 6 months of study entry
- Meets MINI DSM-IV criteria for a substance dependence disorder within 12 months of
study entry
- Shows follicular phase symptoms consistent with a diagnosis of major depression
- Shows symptoms consistent with bipolar disorder
- Diagnosed with a severe, clinically significant co-existing condition that may prevent
study participation
- Suicidal
- Taking ongoing antidepressant or other psychotropic medication
- History of hypersensitivity or an adverse reaction to sertraline
- Pregnant or breastfeeding
- Currently undergoing treatment with a depot hormonal preparation or any other
medication that would lead to a lack of menses or markedly irregular menses
- Using a hormonal contraceptive pill or hormonal device within 6 months of study entry
- Taking a hormonal contraceptive pill that includes 20 micrograms of ethinyl estradiol
and 3 micrograms of drospirenone
- Has been in individual psychotherapy or individual counseling for 3 months or less at
study entry