Official Title: “Symptom Onset Antidepressant Treatment for PMDD”

This study will evaluate the effectiveness of sertraline in reducing symptoms in women diagnosed with premenstrual dysphoric disorder.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: September 2012

Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome (PMS). PMDD affects nearly 5 percent of menstruating women in the United States. This disorder is very disruptive and can affect a woman's performance at work and her relationships with friends and family. Symptoms typically occur 10 to 14 days before the start of a woman's period and dissipate soon after. Sadness, rapid changes in mood, anxiety, and irritability are common symptoms associated with PMDD. Sertraline is a selective serotonin reuptake inhibitor (SSRI) that has been approved by the U.S. Food and Drug Administration (FDA) to treat PMDD. This study will evaluate the effectiveness of sertraline in reducing symptoms in women diagnosed with PMDD.

All participants will begin this study by recording their symptoms for two complete menstrual cycles. At a baseline study visit, participants will then be randomly assigned to receive either sertraline or placebo for six menstrual cycles. At the onset of PMDD symptoms, participants will take two pills of their assigned treatment daily. Once symptoms have dissipated, usually around the first or second day of the menstrual cycle, participants will stop taking their assigned treatment for that cycle. For the next 4 months, participants will attend study visits on the fifth day of each monthly menstrual cycle. For the following 2 months, participants will be contacted by telephone. Participants will be asked to rate their mood and symptoms at each contact. A final study visit will be scheduled on the first day of the seventh menstrual cycle. At this point, all participants will be offered sertraline for an additional three menstrual cycles, dosed on a daily basis. Two study visits will be scheduled over the course of the three cycles to evaluate the effectiveness of sertraline when dosed continuously. Urine collection and pregnancy tests may occur at selected times during the study.

Intervention(s) in this Clinical Trial

• Drug: Sertraline
  • 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
• Drug: Placebo
  • 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Participants will take sertraline
• Placebo Comparator: B
  • Participants will take placebo

Primary Measures

• Premenstrual Tension Scale (PMTS)
  • Time Frame: Measured at Visits 1 through 9
    Safety Issue?: No
• Inventory of Depression Symptoms (IDS)
  • Time Frame: Measured at Visits 1 through 9
    Safety Issue?: No
• Daily Rating of Severity of Problems (DRSP)
  • Time Frame: Measured at Visits 1 through 9
    Safety Issue?: No
• Michelson SSRI Withdrawal Checklist
  • Time Frame: Measured at Visits 2 through 7
    Safety Issue?: No

Secondary Measures

• Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q)
  • Time Frame: Measured at Visits 1, 3, 7, and 9
    Safety Issue?: No
• Clinical Global Impressions (CG-I)
  • Time Frame: Measured at Visits 1 through 9
    Safety Issue?: No
• Harkavy Asnis Suicide Survey II (HASS II)
  • Time Frame: Measured at Visits 1 through 9
    Safety Issue?: No

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 drosperinone
• Has been in individual psychotherapy or individual counseling for 3 months or less at study entry

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 48 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Kimberly A. Yonkers, MD Principal Investigator Yale University  

Overall Contact: Joanne Cunningham, PhD 203-764-5719 joanne.cunningham@yale.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00536198

Study ID Number: R01 MH072955

ClinicalTrials.gov Identifier: NCT00536198

Health Authority: United States: Federal Government

Click here for the PMS, Perinatal, and Postpartum Research Program's Web site