Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder
Primary Purpose
Premenstrual Dysphoric Disorder, Bipolar Disorder
Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Yaz
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Premenstrual Dysphoric Disorder focused on measuring bipolar disorder, premenstrual dysphoric disorder
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.
Sites / Locations
- St Joseph's Healthcare HamiltonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Combined oral contraceptive (3mg drospirenone/ 0.02mg ethinyl estradiol)
Placebo
Arm Description
Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks
Continuous treatment with placebo for 12 weeks
Outcomes
Primary Outcome Measures
Feasibility outcome: treatment compliance
Treatment compliance - assessed via number and percentage of treatment pills taken
Feasibility outcome: retention rates
Retention rates - number and percentage of people who remain in the study once randomized
Feasibility outcome: recruitment rate (monthly)
Recruitment rate (monthly) - number of participants per month
Feasibility outcome: recruitment capacity
Recruitment capacity - total number of participants randomized and enrolled
Feasibility outcome: screening rates (monthly)
Screening rates (monthly) - number screened; number enrolled as a percentage of number screened
Feasibility outcome: duration of assessment process
Duration of assessment process - mean in hours from start to finish for each visit
Feasibility outcome: duration of assessment process
Duration of assessment process - mean in hours from start to finish for each visit
Feasibility outcome: duration of assessment process
Duration of assessment process - mean in hours from start to finish for each visit
Feasibility outcome: duration of assessment process
Duration of assessment process - mean in hours from start to finish for each visit
Feasibility outcome: duration of assessment process
Duration of assessment process - mean in hours from start to finish for each visit
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)
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)
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)
Feasibility outcome: tolerability
Tolerability - assessed as percentage dropped out after randomization due to adverse events
Feasibility outcome: tolerability
Tolerability - assessed as percentage dropped out after randomization due to adverse events
Feasibility outcome: tolerability
Tolerability - assessed as percentage dropped out after randomization due to adverse events
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
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
Feasibility outcome: variance of the treatment effect
Variance of the treatment effect - standard deviation of above measure.
Secondary Outcome Measures
Full Information
NCT ID
NCT05098574
First Posted
July 14, 2021
Last Updated
September 6, 2023
Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Hamilton Academic Health Sciences Organization, McMaster University
1. Study Identification
Unique Protocol Identification Number
NCT05098574
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Hamilton Academic Health Sciences Organization, McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Dysphoric Disorder, Bipolar Disorder
Keywords
bipolar disorder, premenstrual dysphoric disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combined oral contraceptive (3mg drospirenone/ 0.02mg ethinyl estradiol)
Arm Type
Experimental
Arm Description
Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Continuous treatment with placebo for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Yaz
Other Intervention Name(s)
3mg drospirenone/ 0.02mg ethinyl estradiol
Intervention Description
Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Appearance, packaging, and labeling of placebo will be matched to their active counterpart.
Primary Outcome Measure Information:
Title
Feasibility outcome: treatment compliance
Description
Treatment compliance - assessed via number and percentage of treatment pills taken
Time Frame
12 weeks
Title
Feasibility outcome: retention rates
Description
Retention rates - number and percentage of people who remain in the study once randomized
Time Frame
12 weeks
Title
Feasibility outcome: recruitment rate (monthly)
Description
Recruitment rate (monthly) - number of participants per month
Time Frame
2 years
Title
Feasibility outcome: recruitment capacity
Description
Recruitment capacity - total number of participants randomized and enrolled
Time Frame
2 years
Title
Feasibility outcome: screening rates (monthly)
Description
Screening rates (monthly) - number screened; number enrolled as a percentage of number screened
Time Frame
2 years
Title
Feasibility outcome: duration of assessment process
Description
Duration of assessment process - mean in hours from start to finish for each visit
Time Frame
Screening
Title
Feasibility outcome: duration of assessment process
Description
Duration of assessment process - mean in hours from start to finish for each visit
Time Frame
Baseline
Title
Feasibility outcome: duration of assessment process
Description
Duration of assessment process - mean in hours from start to finish for each visit
Time Frame
Week 4
Title
Feasibility outcome: duration of assessment process
Description
Duration of assessment process - mean in hours from start to finish for each visit
Time Frame
Week 8
Title
Feasibility outcome: duration of assessment process
Description
Duration of assessment process - mean in hours from start to finish for each visit
Time Frame
Week 12
Title
Feasibility outcome: safety of use of oral contraceptives in this population
Description
Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)
Time Frame
Week 4
Title
Feasibility outcome: safety of use of oral contraceptives in this population
Description
Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)
Time Frame
Week 8
Title
Feasibility outcome: safety of use of oral contraceptives in this population
Description
Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)
Time Frame
Week 12
Title
Feasibility outcome: tolerability
Description
Tolerability - assessed as percentage dropped out after randomization due to adverse events
Time Frame
Week 4
Title
Feasibility outcome: tolerability
Description
Tolerability - assessed as percentage dropped out after randomization due to adverse events
Time Frame
Week 8
Title
Feasibility outcome: tolerability
Description
Tolerability - assessed as percentage dropped out after randomization due to adverse events
Time Frame
Week 12
Title
Feasibility outcome: response rates
Description
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
Time Frame
Week 12
Title
Feasibility outcome: estimated treatment effect
Description
Estimated treatment effect - mean percent change from baseline to post-treatment in percent change on the MAC-PMSS from late luteal to follicular phase
Time Frame
Week 12
Title
Feasibility outcome: variance of the treatment effect
Description
Variance of the treatment effect - standard deviation of above measure.
Time Frame
Week 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benicio N Frey, MD, MSc, PhD
Phone
(905)522-1155
Ext
33605
Email
freybn@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benicio N Frey, MD, MSc,PhD
Organizational Affiliation
St. Joseph's Healthcare Hamilton
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3K7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benicio N Frey, MD, MSc, PhD
Phone
(905)522-1155
Ext
33605
Email
freybn@mcmaster.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder
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