Postpartum Depression Research Study
Researchers at The University of Texas are inviting moms experiencing postpartum depression who gave birth within the last 15 months to take part in a study. The goal is to learn how RE104, a new investigational medication, might help treat postpartum depression.
Fast Facts
Current Depressive Disorder
Gave Birth Less Than 15 Months Ago
Compensation Provided
Conducted in Austin, TX
Study Background
We understand that being a new mom can be a challenging time, especially when dealing with postpartum depression (PPD). This study is here to explore a potential new treatment, RE104, that may help improve the mental health of mothers experiencing PPD. RE104 is an investigational drug belonging to a class of substances called psychedelics. This study will compare two doses of RE104: a low dose (1.5mg) and a higher dose (30mg). The treatment you’ll receive will be randomly assigned, and neither you nor your doctor will know which dose you’ll get, so we can see how each dose works.
The study consists of three main parts: the screening and baseline period, the study treatment session, and the follow-up visits. During the screening period, we’ll review your health and answer any questions you have about the study. Then, during the treatment session, you’ll receive a single dose of RE104 through an injection in your arm, and we’ll be with you for at least 8 hours to ensure you’re comfortable and cared for. After the treatment, you’ll have 7 follow-up visits, four in-person and three remote, to check in on your progress and experiences. We’re here to support you every step of the way in this important study to better understand and treat postpartum depression.
Study Background
Researchers at The University of Texas are conducting studies in postpartum depression to understand how RE104, a new investigational medication, could help treat this condition and improve the well-being of new mothers.
We understand that being a new mom can be a challenging time, especially when dealing with postpartum depression (PPD). This study is here to explore a potential new treatment, RE104, that may help improve the mental health of mothers experiencing PPD. RE104 is an investigational drug belonging to a class of substances called psychedelics. This study will compare two doses of RE104: a low dose (1.5mg) and a higher dose (30mg). The treatment you’ll receive will be randomly assigned, and neither you nor your doctor will know which dose you’ll get, so we can see how each dose works.
The study consists of three main parts: the screening and baseline period, the study treatment session, and the follow-up visits. During the screening period, we’ll review your health and answer any questions you have about the study. Then, during the treatment session, you’ll receive a single dose of RE104 through an injection in your arm, and we’ll be with you for at least 8 hours to ensure you’re comfortable and cared for. After the treatment, you’ll have 7 follow-up visits, four in-person and three remote, to check in on your progress and experiences. We’re here to support you every step of the way in this important study to better understand and treat postpartum depression.
Additional Information
You may qualify for this study if you meet the following criteria.
Inclusion Criteria:
- Women experiencing postpartum depression
- Gave birth ≤15 months ago
- Have a trusted caregiver who is available to provide continuous care for the infant during a 24-hour visit
- Ages 18-45
- Willing to delay psychotropic pharmacotherapy regimens and/or psychotherapy until Day 7 study assessments
Exclusion Criteria:
- History of or active postpartum psychosis
- History of treatment-resistant depression during the current postpartum depressive episode, defined as inadequate response to pharmacotherapy from two or more different classes of antidepressants
- Current or past diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder, and/or borderline personality disorder; first-degree family history of psychosis or bipolar disorder; or current or past history of seizures (excluding childhood febrile seizures)
- Administration of electroconvulsive therapy or transcranial magnetic stimulation in the past 90 days
- Use of psychedelics in the past 12 months
- Initiation of new psychotherapy in the last 30 days
- Current alcohol or substance use disorder or positive urine drug screen for illicit drugs
Here’s what you can expect during the study:
Screening and Baseline Period:
- You’ll start by signing an informed consent form.
- We’ll complete some assessments and tests to confirm your eligibility for the study.
- If you qualify, we’ll explain the treatment process and help you understand what to expect from the study, including how RE104 works.
Study Treatment/Dosing Session:
- After the screening, you’ll receive one dose of RE104 through an injection in your upper arm.
- There are two possible doses, a low dose (1.5mg) and a high dose (30mg). The dose you’ll receive will be randomly assigned, and neither you nor the study doctor will know which one you get.
- After receiving the dose, we’ll keep you for at least 8 hours to observe how you feel and monitor your safety.
Follow-up Visits:
- There will be seven follow-up visits to track your progress after the treatment:
- Four in-person visits at the study center.
- Three remote visits by telephone.
- These visits will help us understand the effects of the treatment and ensure you’re doing well.
Throughout the study, we’re here to support you every step of the way and answer any questions you might have.
Receive a total compensation up to $975.
There is no cost for you to participate in our research study.