Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder
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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Symptom Onset Antidepressant Treatment for PMDD |
- Premenstrual Tension Scale (PMTS) [ Time Frame: Measured at Visits 1 through 9 ] [ Designated as safety issue: No ]
- Inventory of Depression Symptoms (IDS) [ Time Frame: Measured at Visits 1 through 9 ] [ Designated as safety issue: No ]
- Daily Rating of Severity of Problems (DRSP) [ Time Frame: Measured at Visits 1 through 9 ] [ Designated as safety issue: No ]
- Michelson SSRI Withdrawal Checklist [ Time Frame: Measured at Visits 2 through 7 ] [ Designated as safety issue: No ]
- Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Measured at Visits 1, 3, 7, and 9 ] [ Designated as safety issue: No ]
- Clinical Global Impressions (CG-I) [ Time Frame: Measured at Visits 1 through 9 ] [ Designated as safety issue: No ]
- Harkavy Asnis Suicide Survey II (HASS II) [ Time Frame: Measured at Visits 1 through 9 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
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.
Other Name: Zoloft
|
|
Placebo Comparator: B
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.
Other Name: Placebo, sugar pill
|
Detailed Description:
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: | No |
Inclusion Criteria:
- Menstruating and has cycles between 21 and 35 days
- Meets DSM-IV criteria for PMDD
- Experienced symptoms of PMDD in at least 9 of 12 menstrual cycles within 1 year of study entry
- Willing to use an effective form of birth control throughout the study
Exclusion Criteria:
- Meets MINI DSM-IV criteria for major depressive episode, substance abuse, bulimia nervosa, anorexia, bipolar disorder, or a psychotic disorder, such as schizophrenia or schizoaffective disorder, within 6 months of study entry
- Meets MINI DSM-IV criteria for a substance dependence disorder within 12 months of study entry
- Shows follicular phase symptoms consistent with a diagnosis of major depression
- Shows symptoms consistent with bipolar disorder
- Diagnosed with a severe, clinically significant co-existing condition that may prevent study participation
- Suicidal
- Taking ongoing antidepressant or other psychotropic medication
- History of hypersensitivity or an adverse reaction to sertraline
- Pregnant or breastfeeding
- Currently undergoing treatment with a depot hormonal preparation or any other medication that would lead to a lack of menses or markedly irregular menses
- Using a hormonal contraceptive pill or hormonal device within 6 months of study entry
- Taking a hormonal contraceptive pill that includes 20 micrograms of ethinyl estradiol and 3 micrograms of drospirenone
- Has been in individual psychotherapy or individual counseling for 3 months or less at study entry
Contacts and Locations| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06510 | |
| United States, New York | |
| Cornell University, Weill Medical College | |
| New York, New York, United States, 10021 | |
| United States, Virginia | |
| Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23230 | |
| Principal Investigator: | Kimberly A. Yonkers, MD | Yale University |
| Principal Investigator: | Margaret Altemus, MD | Weill Medical College of Cornell University |
| Principal Investigator: | Susan Kornstein, MD | Virginia Commonwealth University School of Medicine |
More Information
Additional Information:
Publications:
| Responsible Party: | Margaret Altemus, Associate Professor, Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT00536198 History of Changes |
| Other Study ID Numbers: | R01 MH072955, R01MH072955, DSIR 83-ATSO |
| Study First Received: | September 25, 2007 |
| Last Updated: | June 27, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Weill Medical College of Cornell University:
|
Premenstrual Syndrome |
Additional relevant MeSH terms:
|
Premenstrual Syndrome Menstruation Disturbances Pathologic Processes Sertraline Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013