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

Yale University

Status and phase: Completed; Phase 4

Conditions: Premenstrual Dysphoric Disorder

Treatments: Drug: Sertraline; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00536198

0609001839

DSIR 83-ATSO

R01MH072955 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 252 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

252 participants in 2 patient groups, including a placebo group

Sertraline

Experimental group

Description:

Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.

Treatment:

Drug: Sertraline

Placebo

Placebo Comparator group

Description:

Participants will take similar looking placebo during the symptomatic period.

Treatment:

Drug: Placebo