Clinical trial NCT00536198: Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder
Official title: Symptom Onset Antidepressant Treatment for PMDD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Premenstrual Dysphoric Disorder
Keywords: Premenstrual Syndrome
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-09-27
Enrollment: 252
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness of sertraline in reducing symptoms in women diagnosed with premenstrual dysphoric disorder.

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 criteria: 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

Primary outcomes:
measure: Premenstrual Tension Scale (PMTS)
timeFrame: Measured from baseline to Cycle 6
measure: Inventory of Depression Symptoms (IDS-C)
timeFrame: Measured from baseline to Cycle 6
measure: Michelson SSRI Withdrawal Checklist
timeFrame: Measured from Cycle 1 to Cycle 6
measure: Number of Days Pills Were Taken
timeFrame: Measured from Cycle 1 to Cycle 6
measure: Number of Symptomatic Days Before Pills Were Taken
timeFrame: Cycle 1 to Cycle 6
measure: DRSP
timeFrame: Baseline to Cycle 6
Secondary outcomes:
measure: Clinical Global Severity (CGI-S)
timeFrame: Baseline through Cycle 6
measure: DRSP Depression Subscale
timeFrame: Baseline to Cycle 6
measure: DRSP Physical Subscale
timeFrame: Baseline to Cycle 6
measure: DRSP Anger/Irritability Subscale
timeFrame: Baseline to Cycle 6
measure: Clinical Global Impressions-Improvement (CGI-I)
timeFrame: Cycle 1 to Cycle 6
Other outcomes:
measure: Adverse Events
timeFrame: Baseline through Cycle 6
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: New York
country: United States
facility: Cornell University, Weill Medical College
state: New York
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Yale University
name: Kimberly A. Yonkers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Margaret Altemus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University School of Medicine
name: Susan Kornstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yonkers KA, O'Brien PM, Eriksson E. Premenstrual syndrome. Lancet. 2008 Apr 5;371(9619):1200-10. doi: 10.1016/S0140-6736(08)60527-9.
citation: Wallenstein GV, Blaisdell-Gross B, Gajria K, Guo A, Hagan M, Kornstein SG, Yonkers KA. Development and validation of the Premenstrual Symptoms Impact Survey (PMSIS): a disease-specific quality of life assessment tool. J Womens Health (Larchmt). 2008 Apr;17(3):439-50. doi: 10.1089/jwh.2007.0377.
citation: Borenstein JE, Dean BB, Leifke E, Korner P, Yonkers KA. Differences in symptom scores and health outcomes in premenstrual syndrome. J Womens Health (Larchmt). 2007 Oct;16(8):1139-44. doi: 10.1089/jwh.2006.0230.
citation: Borenstein JE, Dean BB, Yonkers KA, Endicott J. Using the daily record of severity of problems as a screening instrument for premenstrual syndrome. Obstet Gynecol. 2007 May;109(5):1068-75. doi: 10.1097/01.AOG.0000259920.73000.3b.
citation: Halbreich U, Backstrom T, Eriksson E, O'brien S, Calil H, Ceskova E, Dennerstein L, Douki S, Freeman E, Genazzani A, Heuser I, Kadri N, Rapkin A, Steiner M, Wittchen HU, Yonkers K. Clinical diagnostic criteria for premenstrual syndrome and guidelines for their quantification for research studies. Gynecol Endocrinol. 2007 Mar;23(3):123-30. doi: 10.1080/09513590601167969.
citation: Hartlage SA, Freels S, Gotman N, Yonkers K. Criteria for premenstrual dysphoric disorder: secondary analyses of relevant data sets. Arch Gen Psychiatry. 2012 Mar;69(3):300-5. doi: 10.1001/archgenpsychiatry.2011.1368.
citation: Yonkers KA, Kornstein SG, Gueorguieva R, Merry B, Van Steenburgh K, Altemus M. Symptom-Onset Dosing of Sertraline for the Treatment of Premenstrual Dysphoric Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Oct;72(10):1037-44. doi: 10.1001/jamapsychiatry.2015.1472.