Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder

Condition(s) targeted: Premenstrual Dysphoric Disorder

Intervention: Sertraline (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: National Institute of Mental Health (NIMH)

Official(s) and/or principal investigator(s):
Kimberly A. Yonkers, MD, Principal Investigator, Affiliation: Yale University
Margaret Altemus, MD, Principal Investigator, Affiliation: Cornell University, Weill Medical College
Susan Kornstein, MD, Principal Investigator, Affiliation: Virginia Commonwealth University School of Medicine

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

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

Official title: Symptom Onset Antidepressant Treatment for PMDD

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

Primary outcome:

Premenstrual Tension Scale (PMTS)

Inventory of Depression Symptoms (IDS)

Daily Rating of Severity of Problems (DRSP)

Michelson SSRI Withdrawal Checklist

Secondary outcome:

Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q)

Clinical Global Impressions (CG-I)

Harkavy Asnis Suicide Survey II (HASS II)

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 48 Years. Gender(s): Female.

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 drosperinone

- Has been in individual psychotherapy or individual counseling for 3 months or less at

study entry

Joanne Cunningham, PhD, Phone: 203-764-5719, Email: joanne.cunningham@yale.edu

Yale University School of Medicine, New Haven, Connecticut 06510, United States; Recruiting
Joanne Cunningham, PhD, Phone: 203-764-5719, Email: joanne.cunningham@yale.edu
Email: women@yale.edu
Kimberly A. Yonkers, MD, Principal Investigator

Cornell University, Weill Medical College, New York, New York 10021, United States; Recruiting
Margaret Altemus, MD, Phone: 212-746-3751, Email: maltemus@med.cornell.edu
Margaret Altemus, MD, Principal Investigator

Virginia Commonwealth University, Richmond, Virginia 23230, United States; Recruiting
Susan Kornstein, MD, Phone: 804-828-5637, Email: skornste@vcu.edu
Susan Kornstein, MD, Principal Investigator

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

Starting date: September 2007
Ending date: September 2012
Last updated: March 9, 2009