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

Premenstrual Dysphoric Disorder Clinical Trial

Official title:

Symptom Onset Antidepressant Treatment for PMDD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00536198
• Other study ID #: R01MH072955
• Secondary ID: R01MH072955DSIR
• Status: Active, not recruiting
• Phase: N/A
• First received: September 25, 2007
• Last updated: June 27, 2012
• Start date: September 2007
• Est. completion date: December 2012

Study information

• Verified date: June 2012
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premenstrual Dysphoric Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Cornell University, Weill Medical College	New York	New York
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Borenstein JE, Dean BB, Leifke E, Korner P, Yonkers KA. Differences in symptom scores and health outcomes in premenstrual syndrome. J Womens Health (Larchmt). 2007 Oct;16(8):1139-44. — View Citation

Borenstein JE, Dean BB, Yonkers KA, Endicott J. Using the daily record of severity of problems as a screening instrument for premenstrual syndrome. Obstet Gynecol. 2007 May;109(5):1068-75. — View Citation

Halbreich U, Backstrom T, Eriksson E, O'brien S, Calil H, Ceskova E, Dennerstein L, Douki S, Freeman E, Genazzani A, Heuser I, Kadri N, Rapkin A, Steiner M, Wittchen HU, Yonkers K. Clinical diagnostic criteria for premenstrual syndrome and guidelines for their quantification for research studies. Gynecol Endocrinol. 2007 Mar;23(3):123-30. — View Citation

Wallenstein GV, Blaisdell-Gross B, Gajria K, Guo A, Hagan M, Kornstein SG, Yonkers KA. Development and validation of the Premenstrual Symptoms Impact Survey (PMSIS): a disease-specific quality of life assessment tool. J Womens Health (Larchmt). 2008 Apr;17(3):439-50. doi: 10.1089/jwh.2007.0377. — View Citation

Yonkers KA, O'Brien PM, Eriksson E. Premenstrual syndrome. Lancet. 2008 Apr 5;371(9619):1200-10. doi: 10.1016/S0140-6736(08)60527-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premenstrual Tension Scale (PMTS)		Measured at Visits 1 through 9	No
Primary	Inventory of Depression Symptoms (IDS)		Measured at Visits 1 through 9	No
Primary	Daily Rating of Severity of Problems (DRSP)		Measured at Visits 1 through 9	No
Primary	Michelson SSRI Withdrawal Checklist		Measured at Visits 2 through 7	No
Secondary	Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q)		Measured at Visits 1, 3, 7, and 9	No
Secondary	Clinical Global Impressions (CG-I)		Measured at Visits 1 through 9	No
Secondary	Harkavy Asnis Suicide Survey II (HASS II)		Measured at Visits 1 through 9	No

External Links

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