Phase 4
N=252
Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder
Premenstrual Dysphoric Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00536198 ↗Enrolled (actual)
252
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Premenstrual Tension Scale (PMTS) — 22.3; 21.4; 15.6; 16.8 units on a scale — p=0.21
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sertraline (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Yale University
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Premenstrual Tension Scale (PMTS) |
22.3; 21.4; 15.6; 16.8; 14.1; 15.6 | 0.21 |
| PRIMARY Inventory of Depression Symptoms (IDS-C) |
35.4; 32.8; 23.7; 24.0; 21.0; 22.8 | 0.54 |
| PRIMARY Michelson SSRI Withdrawal Checklist |
72.9; 68.1; 73.4; 75.2; 70.3; 71.7 | 0.46 |
| PRIMARY Number of Days Pills Were Taken |
6.5; 6.6; 7.4; 6.7; 8.2; 7.1 | 0.30 |
| PRIMARY Number of Symptomatic Days Before Pills Were Taken |
2.8; 2.6; 2.0; 2.7; 1.9; 2.0 | 0.80 |
| PRIMARY DRSP |
60.3; 59.5; 43.7; 46.1; 38.7; 44.4 | 0.83 |
| SECONDARY Clinical Global Severity (CGI-S) |
4.5; 4.5; 3.4; 3.8; 3.1; 3.3 | 0.01 sig |
| SECONDARY DRSP Depression Subscale |
7.5; 7.2; 5.5; 5.7; 4.8; 4.9 | 0.37 |
| SECONDARY DRSP Physical Subscale |
10.6; 10.6; 8.4; 8.4; 8.2; 8.8 | 0.31 |
| SECONDARY DRSP Anger/Irritability Subscale |
6.4; 6.3; 4.1; 4.6; 3.5; 4.5 | <0.001 sig |
| SECONDARY Clinical Global Impressions-Improvement (CGI-I) |
2.7; 3.2; 2.4; 2.7; 2.3; 2.4 | 0.01 sig |
Summary
This study will evaluate the effectiveness of sertraline in reducing symptoms in women diagnosed with premenstrual dysphoric disorder.
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
Data sourced from ClinicalTrials.gov (NCT00536198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.