More about the SOS PMDD Study 

 

Sertraline or Zoloft (FDA approved for the treatment of PMDD ) is being investigated in a "symptom-onset" dosing format. This medication has been shown in many studies to be an effective treatment for PMDD , but many women are reluctant to take a medication every day of the month and would like to minimize side effects. In this ongoing study, participants will take the study medication only on the days that they have PMDD symptoms.

 

The study has three phases:

  • PHASE 1: A two month screening period to evaluate your symptoms and to determine whether you qualify for the treatment study

  • PHASE 2: A six month phase during which you may recieve the study drug sertraline or placebo to take on days you have premenstrual symptoms. If you do not experience symptom relief, the dose will be adjusted. If you still do not experience symptom relief, you may transfer into PHASE 3 before you have completed all six months of PHASE 2.

  • PHASE 3: An optional three month phase during which you take sertraline every day of the month. The dose will be adjusted depending on your symptoms and any side effects you may experience.

 


    Study Participant Qualifications

  • Female

  • Age 18-48

  • Regular menstrual cycles (have a period every month, 24 -35 days apart )

  • Have symptoms oc curing almost every cycle

  • Not currently taking prescription anti-depressant or daily anti-anxiety medication

    The First Step:

  • Please call us
    in New Haven, CT: (203) 762-5711
    in New York, NY (212) 746-3759
    in Richmond, VA (804) 828-5639
      
    Screening Process:

  • We will answer questions about the study and conduct a brief phone interview to determine preliminary eligibility, and then offer to schedule an screening office visit.

  • At the first office visit, we will take a more detailed medical history and ask you to begin keeping daily mood ratings.

  • At the second office visit, we will perform more detailed in-person interviews to evaluate your symptoms and enroll you in the treatment phase of the study if you qualify. If your symptom pattern is more consistent with another disorder, possibly one that worsens premenstrually, we will not enroll you in the study, but will give you referrals for clinicians who can provide treatment.

    HELP US REACH OUR GOAL