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

NCT ID: NCT00536198

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-06
• Study Completion Date: 2012-02-29

Brief Summary

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

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.

Conditions

Premenstrual Dysphoric Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sertraline

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.

Group Type: EXPERIMENTAL

Sertraline

Intervention Type: DRUG

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. 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.

Placebo

Participants will take similar looking placebo during the symptomatic period.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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. 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Zoloft; Placebo, sugar pill

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Kimberly Yonkers

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimberly A. Yonkers, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Margaret Altemus, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Susan Kornstein, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University School of Medicine

Locations

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, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18395582 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18328013 (View on PubMed)

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. doi: 10.1089/jwh.2006.0230.

Reference Type: BACKGROUND

PMID: 17937566 (View on PubMed)

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. doi: 10.1097/01.AOG.0000259920.73000.3b.

Reference Type: BACKGROUND

PMID: 17470584 (View on PubMed)

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. doi: 10.1080/09513590601167969.

Reference Type: BACKGROUND

PMID: 17454164 (View on PubMed)

Hartlage SA, Freels S, Gotman N, Yonkers K. Criteria for premenstrual dysphoric disorder: secondary analyses of relevant data sets. Arch Gen Psychiatry. 2012 Mar;69(3):300-5. doi: 10.1001/archgenpsychiatry.2011.1368.

Reference Type: RESULT

PMID: 22393222 (View on PubMed)

Yonkers KA, Altemus M, Gilstad-Hayden K, Kornstein SG, Gueorguieva R. Does Symptom-Onset Treatment With Sertraline Improve Functional Impairment for Individuals With Premenstrual Dysphoric Disorder?: A Randomized Controlled Trial. J Clin Psychopharmacol. 2023 Jul-Aug 01;43(4):320-325. doi: 10.1097/JCP.0000000000001700. Epub 2023 May 22.

Reference Type: DERIVED

PMID: 37212651 (View on PubMed)

Yonkers KA, Kornstein SG, Gueorguieva R, Merry B, Van Steenburgh K, Altemus M. Symptom-Onset Dosing of Sertraline for the Treatment of Premenstrual Dysphoric Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Oct;72(10):1037-44. doi: 10.1001/jamapsychiatry.2015.1472.

Reference Type: DERIVED

PMID: 26351969 (View on PubMed)

Other Identifiers

R01MH072955

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR 83-ATSO

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0609001839

Identifier Type: -

Identifier Source: org_study_id