Perimenopausal Depression Clinical Trials

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Menopause is Real, so is Perimenopausal Depression!

Struggling with Menopause and Depression? A Clinical Trial May Be An Option!

Perimenopause is the time-frame that defines approaching menopause. For some women this time consists of a lot of emotional and physical changes. Due to the hormonal changes, women experience multiple symptoms including hot flashes, insomnia and depression.

Perimenopausal Depression comes with a wide range of symptoms. Some of the symptoms are typical to depression which is often seen in young men and women. Other symptoms include, low energy, paranoid thinking, irritability, decreased sexual interest and problems with concentration and memory.

At Revive Research Institute we understand that all of these symptoms can take a toll on your mental health. We are conducting novel Clinical Trials to find a potential treatment for Perimenopausal Depression.

You can be a part of the study if:

You are a woman between the age of 40 to 67 years
You are in perimenopausal or early menopausal stage
You have gotten the COVID-19 vaccine

We are conducting a Phase 2 Clinical Trial for women suffering from perimenopausal depression. The goal of the study is to evaluate the safety, efficacy and tolerability of an oral study drug that may be able to help perimenopausal women with their symptoms of depression.

*Participation is free of cost. And no insurance is required.

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About the Perimenopausal Depression Study

A total of 80 women who are perimenopausal or menopausal and are diagnosed with Major Depressive Disorder (MDD) will be enrolled in the Perimenopausal Depression Clinical Trial. The participation will take a total of 3 months, with 28 days of screening phase, 28 days of the treatment phase, and additional 30 days for a post-treatment follow-up phase.

This is a Phase 2, double-blind, placebo-controlled study. This means participants might receive the placebo or the study medication. Unless there is a case of an adverse event, the medication you receive will not be disclosed to you or the study-doctor.

The eligibility criteria entails women within the age group of 40-67 years, who are going through either perimenopause or are menopause and have been diagnosed with MDD at least 4 weeks before the screening.

We are evaluating the efficacy, safety, and tolerability of an oral study drug that may be beneficial in reducing the symptoms of depression in women suffering from perimenopausal depression. This will be made possible by conducting a series of tests and gathering information regarding any adverse events.

*The study drug procedures are free of charge to all the participants. People who meet the study’s eligibility requirements will be compensated for their time and travel. No insurance is required to volunteer in any of our clinical trials.

Get Started: What to Expect?

Perimenopausal depression is a kind of depression that affects women in their perimenopausal years. As women approach menopause, the risk of developing mental health conditions increases. Please fill out the form above to determine whether you qualify for the Perimenopausal Depression Study.

If you fulfill the criteria, someone from the research staff will call you. If you qualify for this phase, you will be invited to a screening visit at our research site. If you qualify after additional tests, you will be asked to sign an informed consent form. After you sign it, you will be asked health-related questions followed by certain tests to see if you are a good fit for the study.

About 30 days following the final dose of experimental drug (evening of Day 28 or at early termination), subjects will be contacted by phone to enquire about severe adverse events (SAEs) and concomitant medicines.

Length of study Treatment

3 months

Number of study visits

Perimenopausal Depression

Long term follow up

Illinois

About Perimenopausal Depression

Perimenopause is the period preceding menopause and the onset of menopause in women. Perimenopause usually strikes women in their 40’s. It causes irregular periods, hot flashes, hormonal imbalances, and insomnia. For some women, the period leading up to menopause (known as perimenopause) is a physical and emotional roller coaster. Hot outbursts, insomnia, mood swings, and even sadness are all signs of the so-called “change of life” brought on by hormonal shifts.

Menopause occurs when the ovaries stop releasing the hormones that allow women to have monthly cycles. Abnormal menstrual periods, hormone imbalances, and sleep issues are all typical during perimenopause. Hot flushes and nighttime sweats are common side effects for many people. It’s not uncommon for perimenopausal women to have mood swings as a result of changing hormone levels.

During perimenopause, women with a history of depression are at a higher risk of mental stress, especially if they are highly sensitive to hormonal changes. There are many Clinical Trials being conducted for women going through menopause. If you or your loved ones have a history of depression, speak to a doctor, especially if the individual is having trouble with emotions during the perimenopause period.

Frequently Asked Questions (FAQs)

1. Is depression normal during perimenopause?

Yes, it is normal to experience depression during perimenopause due to hormonal fluctuations, insomnia and hot flashes.

2. Why do women experience depression in menopausal stage of life?

Anxiety, happiness, and mood are thought to be regulated by serotonin in the brain. Serotonin levels diminish when hormone levels drop, contributing to increased irritation, anxiety, and unhappiness.

3. Is perimenopause associated with emotional issues?

Women going through perimenopause or menopause may experience the following emotional changes: irritability, suffering from sadness, insufficient motivation, and anxiety. It’s always better to let your doctor know how you’re feeling so he or she can rule out any other medical or psychological issues.

4. Where will the study take place?

The study will take place at a site that is in a 50-mile radius from you. If you are interested in participating, please fill the form above, someone from the research team will give you a call and will let you know about the location of the study-site. All participants will be monetarily compensated for their time and travel. You do not have to pay for commuting to the site for the visit. All our clinical trials are free of cost and does not require insurance.