Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

NCT ID: NCT00048854

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30
• Study Completion Date: 2008-01-31

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.

Conditions

Premenstrual Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Participants will receive treatment as usual

Group Type: ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type: OTHER

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.

2

Participants will take sertraline

Group Type: EXPERIMENTAL

Sertraline

Intervention Type: DRUG

Patients who meet study criteria will be given 50 mg per day of sertraline to be taken an estimated 2 weeks before menstruation.

Interventions

Sertraline

Patients who meet study criteria will be given 50 mg per day of sertraline to be taken an estimated 2 weeks before menstruation.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Zoloft; TAU

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimberly A Yonkers, MD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

R21MH062379

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR AT-SO

Identifier Type: -

Identifier Source: secondary_id

0108012595

Identifier Type: -

Identifier Source: org_study_id