Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

Premenstrual Syndrome Clinical Trial

Official title:

Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048854
• Other study ID #: 0108012595
• Secondary ID: R21MH062379DSIR
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 8, 2002
• Last updated: January 11, 2016
• Start date: September 2001
• Est. completion date: January 2008

Study information

• Verified date: January 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Syndrome

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premenstrual Tension Scale (PMTS)		Measured at Month 8	No
Secondary	Inventory of Depressive Symptomatology Clinician-rated version (IDS-C)		Measured at Month 8	No
Secondary	Patient Global Impressions scale		Measured at Month 8	No
Secondary	Quality of Life, Enjoyment, and Satisfaction Questionnaire Scale (Q-LES-Q)		Measured at Month 8	No