Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00048854

Purpose

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.

Condition	Intervention	Phase
Premenstrual Syndrome	Drug: Sertraline Other: Treatment as usual (TAU)	Phase I Phase II

MedlinePlus related topics: Antidepressants Premenstrual Syndrome

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Premenstrual Tension Scale (PMTS) [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Inventory of Depressive Symptomatology Clinician-rated version (IDS-C) [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
Patient Global Impressions scale [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
Quality of Life, Enjoyment, and Satisfaction Questionnaire Scale (Q-LES-Q) [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	September 2001
Estimated Study Completion Date:	October 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Experimental 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.

Arms

Assigned Interventions

1: Active Comparator

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.

2: Experimental

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 48 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048854

Locations

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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Kimberly A Yonkers, MD

Associate Professor

More Information

No publications provided

Responsible Party:	Yale University School of Medicine ( Kimberly Yonkers, MD )
Study ID Numbers:	R21 MH62379, DSIR AT-SO
Study First Received:	November 8, 2002
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00048854 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Neurotransmitter Agents
Depression
Menstruation Disturbances
Mental Disorders
Psychotropic Drugs
Mood Disorders

Sertraline
Depressive Disorder
Serotonin Uptake Inhibitors
Serotonin
Antidepressive Agents
Premenstrual Syndrome

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents

Pathologic Processes
Menstruation Disturbances
Mental Disorders
Syndrome
Therapeutic Uses
Mood Disorders
Sertraline
Central Nervous System Agents
Premenstrual Syndrome
Antidepressive Agents

ClinicalTrials.gov processed this record on May 07, 2009