A Pilot, Randomized, Placebo-Controlled Trial Evaluating the Treatment of Premenstrual Dysphoric Disorder with Oral Contraceptives in Bipolar Disorder.

Who is this study for? Patients with with bipolar disorder
What treatments are being studied? Yaz
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is a pilot, randomized, placebo-controlled trial evaluating the treatment of Premenstrual Dysphoric Disorder comorbid with Bipolar Disorder using combined oral contraceptives. Lay Summary: This study is being done with the hope of finding a safe and effective treatment for individuals who experience both bipolar disorder and severe premenstrual symptoms. As part of this clinical trial, participants will receive either a combined oral contraceptive (i.e. oral birth control pills) as a treatment for severe premenstrual symptoms or a placebo (a pill without any active components - similar to a sugar pill). People that are enrolled in this study will either receive the treatment or the placebo for a period of 90 days. During this time, people that are participating in the study will fill out some questionnaires, and their mental and physical health will be monitored by the study physicians. One of the goals of this study is to also understand whether it is feasible (practical) to do a larger clinical trial using this treatment in this group of people.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Maximum Age: 45
Healthy Volunteers: f
View:

• 16-45 years of age

• Diagnosis of BD (clinically euthymic) according to the DSM-5

• Diagnosis of PMDD according to the DSM-5

• Regular menstrual cycles

• No contraindication to use oral contraceptives

• Capable of consent for treatment

Locations
Other Locations
Canada
St Joseph's Healthcare Hamilton
Hamilton
Time Frame
Start Date: 2023-02-03
Completion Date: 2024-04-11
Participants
Target number of participants: 17
Treatments
Experimental: Combined oral contraceptive (3mg drospirenone/ 0.02mg ethinyl estradiol)
Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks
Placebo_comparator: Placebo
Continuous treatment with placebo for 12 weeks
Sponsors
Collaborators: Hamilton Academic Health Sciences Organization, McMaster University
Leads: St. Joseph's Healthcare Hamilton

This content was sourced from clinicaltrials.gov