Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00536198

Purpose

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

Condition	Intervention
Premenstrual Dysphoric Disorder	Drug: Sertraline Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Symptom Onset Antidepressant Treatment for PMDD

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Premenstrual Syndrome

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Premenstrual Tension Scale (PMTS) [ Time Frame: Measured at Visits 1 through 9 ] [ Designated as safety issue: No ]
Inventory of Depression Symptoms (IDS) [ Time Frame: Measured at Visits 1 through 9 ] [ Designated as safety issue: No ]
Daily Rating of Severity of Problems (DRSP) [ Time Frame: Measured at Visits 1 through 9 ] [ Designated as safety issue: No ]
Michelson SSRI Withdrawal Checklist [ Time Frame: Measured at Visits 2 through 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Measured at Visits 1, 3, 7, and 9 ] [ Designated as safety issue: No ]
Clinical Global Impressions (CG-I) [ Time Frame: Measured at Visits 1 through 9 ] [ Designated as safety issue: No ]
Harkavy Asnis Suicide Survey II (HASS II) [ Time Frame: Measured at Visits 1 through 9 ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Participants will take sertraline	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. Other Name: Zoloft
Placebo Comparator: B Participants will take placebo	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. Other Name: Placebo, sugar pill

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.

Eligibility

Ages Eligible for Study:	18 Years to 48 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536198

Contacts

Contact: Kari VanSteenburgh	203-764-5719	kari.vansteenburgh@yale.edu
Contact: Wendy L Brunetto, MPH	203-764-5973	wendy.brunetto@yale.edu

Locations

United States, Connecticut
Yale University School of Medicine	Recruiting
New Haven, Connecticut, United States, 06510
Contact: Kari VanSteenburgh 203-764-5719 kari.vansteenburgh@yale.edu
Contact women@yale.edu
Principal Investigator: Kimberly A. Yonkers, MD
United States, New York
Cornell University, Weill Medical College	Recruiting
New York, New York, United States, 10021
Contact: Margaret Altemus, MD 212-746-3751 maltemus@med.cornell.edu
Principal Investigator: Margaret Altemus, MD
United States, Virginia
Virginia Commonwealth University	Recruiting
Richmond, Virginia, United States, 23230
Contact: Susan Kornstein, MD 804-828-5637 skornste@vcu.edu
Principal Investigator: Susan Kornstein, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Kimberly A. Yonkers, MD	Yale University
Principal Investigator:	Margaret Altemus, MD	Weill Medical College of Cornell University
Principal Investigator:	Susan Kornstein, MD	Virginia Commonwealth University School of Medicine

More Information

Additional Information:

Click here for the PMS, Perinatal, and Postpartum Research Program's Web site This link exits the ClinicalTrials.gov site

Publications:

Yonkers KA, O'Brien PM, Eriksson E. Premenstrual syndrome. Lancet. 2008 Apr 5;371(9619):1200-10.

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.

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.

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.

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.

Responsible Party:	Kimberly Yonkers, MD, Yale University School of Medicine
ClinicalTrials.gov Identifier:	NCT00536198 History of Changes
Other Study ID Numbers:	R01 MH072955, DSIR 83-ATSO
Study First Received:	September 25, 2007
Last Updated:	June 27, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Premenstrual Syndrome

Additional relevant MeSH terms:

Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 13, 2012