Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder
Status:
Not yet recruiting
Trial end date:
2023-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
St. Joseph's Healthcare Hamilton
Collaborators:
Hamilton Academic Health Sciences Organization McMaster University