Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

This study will determine whether characteristics of women with Premenstrual Syndrome influence response to treatment with serotonin reuptake inhibitors and whether SRIs can alleviate premenstrual symptoms.

Study Overview

• Status: Completed
• Conditions: Premenstrual Syndrome
• Intervention / Treatment: Other: Treatment as usual (TAU); Drug: Sertraline

Detailed Description

Moderate to severe premenstrual disturbances afflict up to 20 percent of women. Studies have shown the use of serotonin reuptake inhibitors (SRIs) during the luteal phase of the menstrual cycle to be effective in improving symptoms in women with premenstrual dysphoric disorder (PMDD). Unfortunately, SRI treatment has only been evaluated in controlled clinical trials, and evidence suggests that patients in these clinical trials are not representative of women commonly seen in clinical practice. Thus, the real-world feasibility of intermittent dosing is questionable.

Patients in this study receive sertraline (Zoloft) during the luteal phase of their menstrual cycle every month for 6 months. The dose may be modified based on structured interviews with the patients. Assessments include questionnaires and interviews which take place at study start, at midpoint, and at the end of the study.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• DSM-IV criteria for Premenstrual syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD)
• For a diagnosis of PMS but not PMDD, patients must have 3 to 4 symptoms, complain of functional impairment as a result of their symptoms, and identify symptoms as problematic enough to warrant treatment
• Symptoms of PMS/PMDD in at least 9 of 12 menstrual cycles during the year prior to screening
• Symptom-free during the follicular phase and impairment during the luteal phase
• Regular menstrual cycles
• Adequate methods of birth control

Exclusion Criteria:

• Major depression, bipolar disorder, or psychotic disorders
• Hepatitis or hepatic failure
• Amenorrhea, oligomenorrhea, blood dyscrasias, or illnesses for which monoamine oxidase inhibitors must be prescribed
• Follicular phase symptoms consistent with a diagnosis of major depression, bipolar disorder, or psychotic disorders
• Co-existing condition that renders the patient unsuitable for the study
• Risk of suicide
• Antidepressants or other psychotropic medication
• Hypersensitivity or adverse reaction to sertraline
• Pregnancy, breast-feeding, or plans to become pregnant during the course of the study
• Depot hormonal preparation or any other medication that would lead to lack of menses or markedly irregular menses

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Participants will receive treatment as usual	Other: Treatment as usual (TAU); At the TAU baseline visit, patients will be told of their diagnosis of PMS/PMDD. Those patients who decide to seek treatment outside of the study protocol or do not wish to seek treatment will be asked to participate in the TAU part of this protocol. Patients in TAU will be contacted monthly to obtain monthly information about how they have been feeling (blinded ratings) using the study measures.; Other Names: TAU
Experimental: 2; Participants will take sertraline	Drug: Sertraline; Patients who meet study criteria will be given 50 mg per day of sertraline to be taken an estimated 2 weeks before menstruation.; Other Names: Zoloft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Premenstrual Tension Scale (PMTS)	Measured at Month 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Inventory of Depressive Symptomatology Clinician-rated version (IDS-C)	Measured at Month 8
Patient Global Impressions scale	Measured at Month 8
Quality of Life, Enjoyment, and Satisfaction Questionnaire Scale (Q-LES-Q)	Measured at Month 8

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Kimberly A Yonkers, MD, Professor

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: November 8, 2002
• First Submitted That Met QC Criteria: November 12, 2002
• First Posted (Estimate): November 13, 2002

Study Record Updates

• Last Update Posted (Estimate): January 12, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Disease; Depressive Disorder; Menstruation Disturbances; Syndrome; Premenstrual Dysphoric Disorder; Premenstrual Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Sertraline
• Other Study ID Numbers: 0108012595; R21MH062379 (U.S. NIH Grant/Contract); DSIR AT-SO (NorthShore LIJ Health System)