Clinical trial NCT05098574: Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder
Official title: A Pilot, Randomized, Placebo-Controlled Trial Evaluating the Treatment of Premenstrual Dysphoric Disorder with Oral Contraceptives in Bipolar Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Premenstrual Dysphoric Disorder
Bipolar Disorder
Keywords: bipolar disorder
premenstrual dysphoric disorder
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Hamilton Academic Health Sciences Organization
name: McMaster University
First posted: 2021-10-28
Enrollment: 17
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Smoking and over the age of 35
* Current or recent (last month) use of systemic estrogen or progesterone treatment
* Severe reactions to hormone treatment
* Pregnant or breastfeeding
* Current substance use disorder
* Oophorectomy or hysterectomy
* Current unstable medical conditions
* History of current or past breast cancer, pancreatitis, migraines or blood clotting disorders.

Primary outcomes:
measure: Feasibility outcome: treatment compliance
timeFrame: 12 weeks
measure: Feasibility outcome: retention rates
timeFrame: 12 weeks
measure: Feasibility outcome: recruitment rate (monthly)
timeFrame: 2 years
measure: Feasibility outcome: recruitment capacity
timeFrame: 2 years
measure: Feasibility outcome: screening rates (monthly)
timeFrame: 2 years
measure: Feasibility outcome: duration of assessment process
timeFrame: Screening
measure: Feasibility outcome: duration of assessment process
timeFrame: Baseline
measure: Feasibility outcome: duration of assessment process
timeFrame: Week 4
measure: Feasibility outcome: duration of assessment process
timeFrame: Week 8
measure: Feasibility outcome: duration of assessment process
timeFrame: Week 12
measure: Feasibility outcome: safety of use of oral contraceptives in this population
timeFrame: Week 4
measure: Feasibility outcome: safety of use of oral contraceptives in this population
timeFrame: Week 8
measure: Feasibility outcome: safety of use of oral contraceptives in this population
timeFrame: Week 12
measure: Feasibility outcome: tolerability
timeFrame: Week 4
measure: Feasibility outcome: tolerability
timeFrame: Week 8
measure: Feasibility outcome: tolerability
timeFrame: Week 12
measure: Feasibility outcome: response rates
timeFrame: Week 12
measure: Feasibility outcome: estimated treatment effect
timeFrame: Week 12
measure: Feasibility outcome: variance of the treatment effect
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Benicio N Frey, MD, MSc,PhD
role: PRINCIPAL_INVESTIGATOR
References: