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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Symptom Onset Antidepressant Treatment for PMDD

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

Detailed Summary:

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 occu
Sponsor: Yale University

Current Primary Outcome:

• Premenstrual Tension Scale (PMTS) [ Time Frame: Measured from baseline to Cycle 6 ]
  The PMTS is a 10-item scale constructed to study premenstrual syndromes. It is sensitive to change with treatment. It includes items of irritability-hostility, tension, efficiency, dysphoria, motor coordination, mental-cognitive functioning, eating habits, social impairment, sex drive, and physical symptoms. PMTS-O or PMTS-SR? Min=0 (asymptomatic), Max=40 (Highly symptomatic), higher scores indicate most severe problems
• Inventory of Depression Symptoms (IDS-C) [ Time Frame: Measured from baseline to Cycle 6 ]
  Inventory of Depressive Symptomatology-Clinician version (IDS-C) - a depression measure that has 28 items and detects appropriate variations between follicular and luteal phases in subjects with PMDD. Min score is 0, max is 84.Lower score is less symptomatic.
• Michelson SSRI Withdrawal Checklist [ Time Frame: Measured from Cycle 1 to Cycle 6 ]
  Michelson SSRI Withdrawal Checklist - 16-item (not exactly 17-item, mood swings and crying were in DRSP) including dizziness, nausea, unusual dreams, chills, increased sweating, loose stools, agitation, ringing or noises in the ears. Items were summed for 3 days after pill-taking ended for each menstrual cycle.Scale is 0-80 for total range of the scale with lower less severe. There are no units
• Number of Days Pills Were Taken [ Time Frame: Measured from Cycle 1 to Cycle 6 ]
  The number of days that pills were taken on.
• Number of Symptomatic Days Before Pills We
  
  

  Original Primary Outcome:

  • Premenstrual Tension Scale (PMTS) [ Time Frame: Measured at Visits 1 through 9 ]
  • Inventory of Depression Symptoms (IDS) [ Time Frame: Measured at Visits 1 through 9 ]
  • Daily Rating of Severity of Problems (DRSP) [ Time Frame: Measured at Visits 1 through 9 ]
  • Michelson SSRI Withdrawal Checklist [ Time Frame: Meausured at visits 2 through 6 ]
  
  
  

  Current Secondary Outcome:

  • Clinical Global Severity (CGI-S) [ Time Frame: Baseline through Cycle 6 ]
    Clinical Global Impressions-Severity is measured on a scale of 1-7, with 7 as most severe.
  • DRSP Depression Subscale [ Time Frame: Baseline to Cycle 6 ]
    Depressive symptoms included: felt depressed, felt hopeless, felt worthless or guilt, slept more, trouble sleeping, felt overwhelmed. Symptoms were scored on a scale of 1-6 The score range is 0-36 with higher indicating greater severity.
  • DRSP Physical Subscale [ Time Frame: Baseline to Cycle 6 ]
    Physical symptoms included breast tenderness, bloating, headache, joint or muscle pain. Symptoms were scored on a scale of 1-6. The severity range is 0-24 with 24 being more symptomatic.
  • DRSP Anger/Irritability Subscale [ Time Frame: Baseline to Cycle 6 ]
    Anger/irritability included anger/irritability and conflicts with people. Symptoms were scored on a scale 1-6. The range is 0 to 12 with a higher score indicating greater symptom severity.
  • Clinical Global Impressions-Improvement (CGI-I) [ Time Frame: Cycle 1 to Cycle 6 ]
    The Clinical Global Impressions-Improvement (CGI-I) scale is a 7-point scale with 7 being the least improvement.
  
  
  

  Original Secondary Outcome:

  • Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Measured at Visits 1, 3, 7, and 9 ]
  • Clinical Global Impressions (CG-I) [ Time Frame: Measured at Visits 1 through 9 ]
  • Harkavy Asnis Suicide Survey II (HASS II) [ Time Frame: Measured at Visits 1 through 9 ]
  
  
  Information By: Yale University
  

  Dates:
  Date Received: September 25, 2007
  Date Started: November 6, 2007
  Date Completion:
  Last Updated: March 16, 2017
  Last Verified: March 2017