Hormonal Contraceptives for Depression
(CHARM Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants do not currently use hormonal contraceptives or medications that affect sex hormones. Additionally, participants cannot be on psychotropic medications. If you are taking these types of medications, you may need to stop them to participate.
What data supports the effectiveness of the drug Levonorgestrel/ethinyl estradiol for depression?
The research suggests that hormonal contraceptives, including those containing ethinyl estradiol, may be linked to mood changes and depression in some women. However, there is no clear consensus or strong evidence supporting their effectiveness for treating depression, and more research is needed to understand their impact on mood disorders.12345
Is hormonal contraception generally safe for humans?
Hormonal contraceptives are widely used, but they can cause mood changes, including depression, in some people. Some studies suggest a link between contraceptive use and increased risk of depression and suicide, especially in adolescents, but the evidence is not conclusive. It's important to monitor mood changes when using these contraceptives.14678
How does the drug Levonorgestrel/ethinyl estradiol differ from other treatments for depression?
Levonorgestrel/ethinyl estradiol is primarily a hormonal contraceptive, and its use for depression is unique because it involves hormones that can affect mood. Unlike traditional antidepressants, this drug's impact on depression may be linked to its hormonal components, which can sometimes worsen mood in some users, highlighting the need for careful consideration of its effects on mental health.145910
What is the purpose of this trial?
Purpose of this study: The purpose of this study is to learn more about how hormonal oral contraceptives affect brain processes and emotional wellbeing.Procedures: If participants agree to participate, the following will happen:1. Eligibility visit (remote screening session)2. If participants are eligible to participate in the study, they will be placed in one of two groups. If they are in the first group, they will be asked to take an oral contraception pill ("study drug") every day for 21 days. If they are in the second, they will take a placebo every day for 21 days. A placebo is a pill that looks like medicine but is not real and will have no medical effect on participants. Participants will not get to choose which group they are in, nor will they be told which group they are in.3. During the three-week period in which participants will take either the study drug or placebo, they will be asked to complete daily check-in surveys on their computer or mobile device.4. Participants will be asked to attend two additional visits over the course of about three weeks. At these visits, participants will be asked to undergo a urine drug screen, a blood draw, and a magnetic resonance imaging (MRI). They will also be asked to complete behavioral questionnaires.
Research Team
Andrew M Novick, MD PhD
Principal Investigator
University of Colorado Denver Anschutz Medical Campus
Eligibility Criteria
The CHARM Study is for right-handed females aged 18+, with regular menstrual cycles and good health. Participants must not smoke, have a history of severe disorders, or use hormonal contraceptives recently. They should be willing to avoid intercourse or use non-hormonal contraception during the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take either an oral contraceptive or placebo daily for 21 days and complete daily check-in surveys
Follow-up
Participants are monitored for changes in sexual function, anhedonia, and neural activity after treatment
Treatment Details
Interventions
- Levonorgestrel/ethinyl estradiol
- Placebo
Levonorgestrel/ethinyl estradiol is already approved in European Union, United States, Canada, Japan for the following indications:
- Contraception
- Menstrual regulation
- Premenstrual dysphoric disorder
- Contraception
- Premenstrual dysphoric disorder
- Acne vulgaris
- Contraception
- Menstrual regulation
- Premenstrual dysphoric disorder
- Contraception
- Menstrual regulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor