Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
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|ClinicalTrials.gov Identifier: NCT00048854|
Recruitment Status : Completed
First Posted : November 13, 2002
Last Update Posted : January 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Premenstrual Syndrome||Drug: Sertraline Other: Treatment as usual (TAU)||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder|
|Study Start Date :||September 2001|
|Primary Completion Date :||June 2007|
|Study Completion Date :||January 2008|
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
Participants will take 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
- Premenstrual Tension Scale (PMTS) [ Time Frame: Measured at Month 8 ]
- Inventory of Depressive Symptomatology Clinician-rated version (IDS-C) [ Time Frame: Measured at Month 8 ]
- Patient Global Impressions scale [ Time Frame: Measured at Month 8 ]
- Quality of Life, Enjoyment, and Satisfaction Questionnaire Scale (Q-LES-Q) [ Time Frame: Measured at Month 8 ]
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 ClinicalTrials.gov identifier (NCT number): NCT00048854
|United States, Connecticut|
|Yale School of Medicine|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Kimberly A Yonkers, MD||Professor|