Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05098574
• Other study ID #: BDPMDD01
• Status: Recruiting
• Phase: Phase 2
• Start date: November 30, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: St. Joseph's Healthcare Hamilton
• Contact: Benicio N Frey, MD, MSc, PhD
• Phone: (905)522-1155
• Email: freybn[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Premenstrual Dysphoric Disorder

Intervention

Drug:
• Yaz
Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks
• Placebo
Appearance, packaging, and labeling of placebo will be matched to their active counterpart.

Locations

Country	Name	City	State
Canada	St Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	Hamilton Academic Health Sciences Organization, McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility outcome: treatment compliance	Treatment compliance - assessed via number and percentage of treatment pills taken	12 weeks
Primary	Feasibility outcome: retention rates	Retention rates - number and percentage of people who remain in the study once randomized	12 weeks
Primary	Feasibility outcome: recruitment rate (monthly)	Recruitment rate (monthly) - number of participants per month	2 years
Primary	Feasibility outcome: recruitment capacity	Recruitment capacity - total number of participants randomized and enrolled	2 years
Primary	Feasibility outcome: screening rates (monthly)	Screening rates (monthly) - number screened; number enrolled as a percentage of number screened	2 years
Primary	Feasibility outcome: duration of assessment process	Duration of assessment process - mean in hours from start to finish for each visit	Screening
Primary	Feasibility outcome: duration of assessment process	Duration of assessment process - mean in hours from start to finish for each visit	Baseline
Primary	Feasibility outcome: duration of assessment process	Duration of assessment process - mean in hours from start to finish for each visit	Week 4
Primary	Feasibility outcome: duration of assessment process	Duration of assessment process - mean in hours from start to finish for each visit	Week 8
Primary	Feasibility outcome: duration of assessment process	Duration of assessment process - mean in hours from start to finish for each visit	Week 12
Primary	Feasibility outcome: safety of use of oral contraceptives in this population	Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)	Week 4
Primary	Feasibility outcome: safety of use of oral contraceptives in this population	Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)	Week 8
Primary	Feasibility outcome: safety of use of oral contraceptives in this population	Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)	Week 12
Primary	Feasibility outcome: tolerability	Tolerability - assessed as percentage dropped out after randomization due to adverse events	Week 4
Primary	Feasibility outcome: tolerability	Tolerability - assessed as percentage dropped out after randomization due to adverse events	Week 8
Primary	Feasibility outcome: tolerability	Tolerability - assessed as percentage dropped out after randomization due to adverse events	Week 12
Primary	Feasibility outcome: response rates	Response rates - response will be defined as 50% decrease from baseline symptom change from late luteal to follicular phase; remission will be defined as number and percentage of responders who no longer need DSM-5 criteria for PMDD	Week 12
Primary	Feasibility outcome: estimated treatment effect	Estimated treatment effect - mean percent change from baseline to post-treatment in percent change on the MAC-PMSS from late luteal to follicular phase	Week 12
Primary	Feasibility outcome: variance of the treatment effect	Variance of the treatment effect - standard deviation of above measure.	Week 12