The Oral Contraceptive Pill for Premenstrual Worsening of Depression

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Amenorrhea or irregular menstrual periods (defined as unable to predict within 7 days) during past 6 months
Pregnancy or breastfeeding (serum HCG test administered at baseline study visit, and urine HCG at visits 3 and 5)
Current cigarette smoking in women who are older than 34 years
Presence of any of the following psychiatric and substance use disorders, based on administration of the MINI at the baseline study visit:

Any history of mania or hypomania suggesting bipolar disorder Any lifetime history of a psychotic disorder
Depression deemed by the physician investigator to be too severe to be treated in the study
Use of benzodiazepines or antipsychotic to target premenstrual symptoms
Luteal-phase dose adjustment of the antidepressant. Use of a hormone releasing IUD (intrauterine device)
Use of an OCP or other systemic hormonal therapies (oral, transdermal or injection preparations of androgens, estrogens, or progestins) in the past 2 months;
Any contraindication or previous adverse event to any OCP therapy;
Current use of ketoconazole, rifampin, carbamazepine, topiramate, oxcarbazepine, modafinil, phenytoin, or phenobarbital (because of interaction with hormonal therapy).
Current use of potassium-sparing agents, such as potassium-sparing diuretics (e.g., spironolactone), ACE inhibitors, angiotensin-II receptor antagonists, heparin, aldosterone antagonists, NSAIDS, potassium sparing diuretics or potassium-supplements (because of risk of developing arrhythmia with two potassium-elevating agents).
Hepatic dysfunction, renal insufficiency, pulmonary, adrenal, or metabolic diseases (including elevated serum potassium levels, if known) that may put subject at risk when treated with study medication.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drospirenone and ethinyl estradiol	Drospirenone and ethinyl estradiol	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percent Change in Luteal Montgomery-Asberg Depression Rating Scale (MADRS)	Baseline and 2 months	The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and during 2nd treatment month in order to calculate the change in MADRS score.

Secondary Outcome Measures

Name	Time	Method
Percent Change in Daily Record of Severity of Problems (DRSP)	Baseline and 2 months	The DRSP is a 24-item self-administered daily dairy that assesses the severity of mood and physical symptoms which occur as part of the premenstrual syndrome and PMDD. Each question is rated on a scale of 1-6 with a total score range from 24-144. A higher score indicates greater symptom burden.