Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder
Summary
This study will evaluate the effectiveness of sertraline in reducing symptoms in women diagnosed with premenstrual dysphoric disorder.
Timeline
- Start
- 2007-11-06
- Primary completion
- 2012-02
- Completion
- 2012-02
Outcome
Mixed primary results
paper PMTS score was the primary outcome measure PMID 26351969 ↗
paper group mean difference, 1.88 (95% CI, 0.01-3.75; P = .06). PMID 26351969 ↗
registry MEAN Sertraline: Average change from baseline: -20.0 (Standard Deviation 11.4) units on a scale NCT00536198 ↗
registry MEAN Placebo: Average change from baseline: -15.3 (Standard Deviation 12.5) units on a scale NCT00536198 ↗
registry analysis (superiority or other test); Sertraline vs Placebo; p = 0.0015; Mean Difference (Net) 5.14 (95% CI 1.97 to 8.31); Mixed Models Analysis NCT00536198 ↗
registry analysis (superiority or other test); Sertraline vs Placebo; p = 0.84; Mean Difference (Net) 1.02 (95% CI 0.83 to 1.26); Mixed Models Analysis NCT00536198 ↗
registry analysis (superiority or other test); Sertraline vs Placebo; p = 0.06; Mean Difference (Net) 1.12 (95% CI 0.92 to 1.35); Mixed Models Analysis NCT00536198 ↗
registry analysis (superiority or other test); Sertraline vs Placebo; p = 0.61; Mean Difference (Net) 1.11 (95% CI 0.85 to 1.45); Mixed Models Analysis NCT00536198 ↗
registry analysis (superiority or other test); Sertraline vs Placebo; p = 0.169; Mean Difference (Net) 1.09 (95% CI 0.96 to 1.25); Mixed Models Analysis NCT00536198 ↗
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Results 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.
- Yonkers KA, Altemus M, Gilstad-Hayden K, Kornstein SG, Gueorguieva R. Does Symptom-Onset Treatment With Sertraline Improve Functional Impairment for Individuals With Premenstrual Dysphoric Disorder?: A Randomized Controlled Trial. J Clin Psychopharmacol. 2023 Jul-Aug 01;43(4):320-325. doi: 10.1097/JCP.0000000000001700. Epub 2023 May 22.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sertraline | Small molecule | 25 mg | — |
| Subject | Sertraline | Small molecule | 50 mg | — |
| Subject | Sertraline | Small molecule | 100 mg | — |