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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Weill Medical College of Cornell University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Margaret Altemus, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00536198
First received: September 25, 2007
Last updated: June 27, 2012
Last verified: June 2012
  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:


Further study details as provided by Weill Medical College of Cornell University:

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: December 2012
Estimated Primary Completion Date: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, New York
Cornell University, Weill Medical College
New York, New York, United States, 10021
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23230
Sponsors and Collaborators
Weill Medical College of Cornell University
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:
Publications:
Responsible Party: Margaret Altemus, Associate Professor, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00536198     History of Changes
Other Study ID Numbers: R01 MH072955, R01MH072955, DSIR 83-ATSO
Study First Received: September 25, 2007
Last Updated: June 27, 2012
Health Authority: United States: Federal Government

Keywords provided by Weill Medical College of Cornell University:
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 July 29, 2014