What side effects are associated with this type of intervention?

Common treatments for Bipolar Disorder include mood stabilizers like lithium and valproate, antipsychotics, and sometimes antidepressants. Lithium can cause side effects such as tremor, increased thirst, diarrhea, and subclinical hypothyroidism. Valproate may lead to weight gain, gastrointestinal issues, and liver toxicity. Antipsychotics can cause metabolic side effects, including weight gain and increased risk of diabetes. Hormonal treatments like combined oral contraceptives, while not standard for Bipolar Disorder, can have side effects such as nausea, weight gain, mood changes, and increased risk of blood clots.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Bipolar Disorder, including mood stabilizers like lithium and anticonvulsants such as valproate and lamotrigine. Additionally, second-generation antipsychotics like risperidone, quetiapine, and olanzapine are commonly used. While combined oral contraceptives are being studied for their potential to regulate hormone levels in treating Bipolar Disorder, there is limited information on FDA approvals specifically for hormone regulation in this context. Current treatments focus more broadly on mood stabilization and managing manic and depressive episodes.

What other types of research exist?

Promising alternatives to Combined Oral Contraceptives for Bipolar Disorder patients include the use of mood stabilizers such as lamotrigine and lithium, which have shown efficacy in managing bipolar symptoms. Additionally, selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) may be considered for their antidepressant effects. Hormonal treatments like continuous administration of levonorgestrel/ethinyl estradiol (LNG/EE) COCs could also be explored, although they require careful monitoring due to potential side effects. Consulting with a healthcare provider is essential to tailor the treatment plan to individual needs.

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Combined Oral Contraceptive

Oral Contraceptives for Premenstrual Dysphoric Disorder

Phase 2

Waitlist Available

Led By Benicio N Frey, MD, MSc,PhD

Research Sponsored by St. Joseph's Healthcare Hamilton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

16-45 years of age

No contraindication to use oral contraceptives

Must not have

Current unstable medical conditions

Oophorectomy or hysterectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial is testing whether birth control pills can help people who have both severe premenstrual symptoms and bipolar disorder. Participants will take the birth control pills for a few months, and their health will be monitored. The goal is to see if this treatment is effective and practical for a larger study.

Who is the study for?

This trial is for individuals aged 16-45 with bipolar disorder who are stable and have severe premenstrual symptoms (PMDD). They must be able to consent, not smoke if over 35, have regular menstrual cycles, and no history of hormone-sensitive cancers or clotting disorders. Those pregnant, breastfeeding, or with recent hormone treatments cannot join.

What is being tested?

The study tests whether oral contraceptives can help manage severe premenstrual symptoms in those also dealing with bipolar disorder. Participants will randomly receive either the contraceptive Yaz or a placebo for three months while their health is monitored.

What are the potential side effects?

Potential side effects from the oral contraceptive may include nausea, headaches, mood changes, breast tenderness, and spotting between periods. The risk of blood clots may also be slightly increased.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 16 and 45 years old.

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I can safely use oral contraceptives.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unstable health conditions.

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I have had my ovaries or uterus removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility outcome: duration of assessment process

Feasibility outcome: estimated treatment effect

Feasibility outcome: recruitment capacity

+8 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Combined oral contraceptive (3mg drospirenone/ 0.02mg ethinyl estradiol)Experimental Treatment1 Intervention

Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks

Group II: PlaceboPlacebo Group1 Intervention

Continuous treatment with placebo for 12 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Drospirenone

FDA approved

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Bipolar Disorder include mood stabilizers, antipsychotics, and anticonvulsants. Lithium works by modulating neurotransmitter activity and stabilizing mood swings, while valproate increases levels of gamma-aminobutyric acid (GABA) to calm neural activity. Antipsychotics like risperidone and quetiapine target dopamine and serotonin receptors to manage manic and psychotic symptoms. Lamotrigine, an anticonvulsant, stabilizes mood by inhibiting glutamate release and blocking sodium channels. Additionally, hormone regulation through combined oral contraceptives may help manage mood fluctuations by stabilizing estrogen and progesterone levels. These treatments are crucial for Bipolar Disorder patients as they help maintain mood stability, reduce the frequency of mood episodes, and improve overall quality of life.

A systematic review of the evidence on the treatment of rapid cycling bipolar disorder.