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Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder Clinical research trials and Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder. Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder clinical trial. Participants oftentimes recieve the finest healthcare available for their Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder  Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
For Condition: Premenstrual Syndrome
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/48 Years
Genders: Female
Protocol Entry 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
Total Enrollment: 120
Location and Contact Information:
Women and Infants Hospital *Recruiting*
Providence, Rhode Island, 02905
United States
Recruiting Teri Pearlstein 401-453-7955
Yale School of Medicine *Recruiting*
New Haven, Connecticut, 06510
United States
Recruiting Kimberly Yonkers 203-764-6621
Additional Information:
Study ID Numbers: 62379-01A1;
Study Start Date: September 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048854
Other Premenstrual Syndrome Studies:
1. Altered Calcium and Vitamin D in PMDD or Severe PMS
2. Combined Hormone Replacement in Menstrually-Related Mood Disorders
3. Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
Related Studies:
Other Premenstrual Syndrome Clinical Trials
Other Rhode Island Clinical Trials
Other Providence Clinical Trials
Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
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