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Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00048854
Recruitment Status : Completed
First Posted : November 13, 2002
Last Update Posted : January 12, 2016
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Premenstrual Syndrome Drug: Sertraline Other: Treatment as usual (TAU) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
Study Start Date : September 2001
Actual Primary Completion Date : June 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

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 Name: 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 Name: Zoloft

Primary Outcome Measures :
  1. Premenstrual Tension Scale (PMTS) [ Time Frame: Measured at Month 8 ]

Secondary Outcome Measures :
  1. Inventory of Depressive Symptomatology Clinician-rated version (IDS-C) [ Time Frame: Measured at Month 8 ]
  2. Patient Global Impressions scale [ Time Frame: Measured at Month 8 ]
  3. Quality of Life, Enjoyment, and Satisfaction Questionnaire Scale (Q-LES-Q) [ Time Frame: Measured at Month 8 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00048854

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United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
National Institute of Mental Health (NIMH)
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Principal Investigator: Kimberly A Yonkers, MD Professor
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Responsible Party: Yale University Identifier: NCT00048854    
Other Study ID Numbers: 0108012595
R21MH062379 ( U.S. NIH Grant/Contract )
First Posted: November 13, 2002    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Premenstrual Syndrome
Premenstrual Dysphoric Disorder
Pathologic Processes
Menstruation Disturbances
Depressive Disorder
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs