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Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
This study is currently recruiting patients.
Sponsored by: | National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
Purpose
The purpose of this study is to determine whether women with moderate to severe Premenstrual Syndrome (PMS) are willing and able to adhere to drug treatment that is limited to half of their menstrual cycle. This study will also determine whether patient characteristics influence response to treatment with serotonin reuptake inhibitors (SRIs) and whether SRIs can alleviate premenstrual symptoms.
Condition | Treatment or Intervention |
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Premenstrual Syndrome |
Drug: Sertraline (Zoloft) |
MedlinePlus related topics: Premenstrual Syndrome
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: R-21
Expected Total Enrollment: 120
Study start: September 2001
Moderate to severe premenstrual disturbances afflict up to 20 percent of women. Studies have shown the use of 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 - 48 Years, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
Exclusion Criteria:
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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