Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

Phase 1

Completed

• Conditions: Premenstrual Syndrome
• Interventions: Other: Treatment as usual (TAU); Drug: Sertraline

• Registration Number: NCT00048854
• Lead Sponsor: Yale University

Brief Summary

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.

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 Timeline

• Study Start: 2001-09
• Study First Submitted: 2002-11-08
• Study First Submitted QC: 2002-11-12
• Study First Posted: 2002-11-13
• Primary Completion: 2007-06
• Study Completion: 2008-01
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Treatment as usual (TAU)	Participants will receive treatment as usual
2	Sertraline	Participants will take sertraline

Primary Outcome Measures

Name	Time	Method
Premenstrual Tension Scale (PMTS)	Measured at Month 8

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States