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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00536198 |
Purpose
This study will evaluate the effectiveness of sertraline in reducing symptoms in women diagnosed with premenstrual dysphoric disorder.
| Condition | Intervention |
|---|---|
|
Premenstrual Dysphoric Disorder |
Drug: Sertraline Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Symptom Onset Antidepressant Treatment for PMDD |
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Participants will take sertraline
|
Drug: Sertraline
50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
|
B: Placebo Comparator
Participants will take placebo
|
Drug: Placebo
50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome (PMS). PMDD affects nearly 5 percent of menstruating women in the United States. This disorder is very disruptive and can affect a woman's performance at work and her relationships with friends and family. Symptoms typically occur 10 to 14 days before the start of a woman's period and dissipate soon after. Sadness, rapid changes in mood, anxiety, and irritability are common symptoms associated with PMDD. Sertraline is a selective serotonin reuptake inhibitor (SSRI) that has been approved by the U.S. Food and Drug Administration (FDA) to treat PMDD. This study will evaluate the effectiveness of sertraline in reducing symptoms in women diagnosed with PMDD.
All participants will begin this study by recording their symptoms for two complete menstrual cycles. At a baseline study visit, participants will then be randomly assigned to receive either sertraline or placebo for six menstrual cycles. At the onset of PMDD symptoms, participants will take two pills of their assigned treatment daily. Once symptoms have dissipated, usually around the first or second day of the menstrual cycle, participants will stop taking their assigned treatment for that cycle. For the next 4 months, participants will attend study visits on the fifth day of each monthly menstrual cycle. For the following 2 months, participants will be contacted by telephone. Participants will be asked to rate their mood and symptoms at each contact. A final study visit will be scheduled on the first day of the seventh menstrual cycle. At this point, all participants will be offered sertraline for an additional three menstrual cycles, dosed on a daily basis. Two study visits will be scheduled over the course of the three cycles to evaluate the effectiveness of sertraline when dosed continuously. Urine collection and pregnancy tests may occur at selected times during the study.
Eligibility| Ages Eligible for Study: | 18 Years to 48 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Joanne Cunningham, PhD | 203-764-5719 | joanne.cunningham@yale.edu |
| United States, Connecticut | |
| Yale University School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Contact: Joanne Cunningham, PhD 203-764-5719 joanne.cunningham@yale.edu or women@yale.edu | |
| Principal Investigator: Kimberly A. Yonkers, MD | |
| United States, New York | |
| Cornell University, Weill Medical College | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Margaret Altemus, MD 212-746-3751 maltemus@med.cornell.edu | |
| Principal Investigator: Margaret Altemus, MD | |
| United States, Virginia | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23230 | |
| Contact: Susan Kornstein, MD 804-828-5637 skornste@vcu.edu | |
| Principal Investigator: Susan Kornstein, MD | |
| Principal Investigator: | Kimberly A. Yonkers, MD | Yale University |
| Principal Investigator: | Margaret Altemus, MD | Cornell University, Weill Medical College |
| Principal Investigator: | Susan Kornstein, MD | Virginia Commonwealth University School of Medicine |
More Information
| Responsible Party: | Yale University School of Medicine ( Kimberly Yonkers, MD ) |
| Study ID Numbers: | R01 MH072955, DSIR 83-ATSO |
| Study First Received: | September 25, 2007 |
| Last Updated: | March 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00536198 |
| Health Authority: | United States: Federal Government |
|
Premenstrual Syndrome |
|
Depression Menstruation Disturbances Mental Disorders Mood Disorders |
Sertraline Depressive Disorder Serotonin Premenstrual Syndrome |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors |
Pharmacologic Actions Pathologic Processes Serotonin Agents Therapeutic Uses Central Nervous System Agents Antidepressive Agents |
