RE104 for Postpartum Depression

Recruiting at 31 trial locations

Overseen By Jasna Hocevar-Trnka, M.D.

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Reunion Neuroscience Inc

Must be taking: SSRIs

Must not be taking: Psychotropics, Psychedelics

Disqualifiers: Bipolar, Schizophrenia, Psychosis, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing whether a single injection of RE104 can help reduce depression in women who have moderate-to-severe postpartum depression. The goal is to see if this treatment works effectively. The exact way RE104 works isn't detailed, but it likely helps by affecting brain chemicals related to mood.

Will I have to stop taking my current medications?

The trial requires that you are either not using any psychotropic medications or psychotherapy for 30 days before screening, or you are on a stable regimen of SSRIs or psychotherapy for 30 days before screening. If you are on other medications, you may need to stop them.

How is the drug RE104 for Injection different from other drugs for postpartum depression?

RE104 for Injection, also known as 4-OH-DiPT, is unique because it is a novel compound not previously used for postpartum depression, unlike existing treatments like brexanolone, which is a neurosteroid that modulates GABA receptors. This makes RE104 potentially different in its mechanism of action and effects. ^{1 2 3 4 5}

Research Team

Jasna Hocevar-Trnka, M.D.

Principal Investigator

Reunion Neuroscience Inc

Eligibility Criteria

This trial is for individuals who are within 12 months postpartum and have moderate-to-severe depression. They must not be breastfeeding, meet specific criteria on the Hamilton Depression Scale, and either be free from psychotropic medications and psychotherapy for 30 days or on a stable regimen of SSRIs or therapy.

Inclusion Criteria

I gave birth within the last 12 months.

My depression severity meets the required level on the HAM-D scale.

I haven't started any new mental health treatments in the last 30 days.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subcutaneous injection of either 30 mg or 1.5 mg RE104 for Injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

3 visits (in-person) on Day 7, Day 14, and Day 28

Treatment Details

Interventions

• RE104 for Injection (Other)

Trial Overview The study tests whether a single dose of RE104 for Injection can reduce depressive symptoms in those with postpartum depression compared to an active-placebo. It aims to see if this new treatment is safe and effective.

Participant Groups

Group I: 30 mg RE104 Experimental Treatment 1 Intervention

A single subcutaneous injection of 30 mg RE104 for Injection

Group II: 1.5 mg RE104 Active Control 1 Intervention

A single subcutaneous injection of 1.5 mg RE104 for Injection

Who Is Running the Clinical Trial?

Reunion Neuroscience Inc

Lead Sponsor

Trials

2

Recruited

90+

Findings from Research

Brexanolone, a synthetic neuroactive steroid, has shown rapid effectiveness in reducing depressive symptoms in postpartum depression, leading to its submission for FDA approval.

SAGE-217, an oral allopregnanolone analog, and ganaxolone, a synthetic analog being tested in various forms, also demonstrate promising results in treating severe postpartum depression, indicating a new direction in postpartum depression therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of Postpartum Depression: Current Approaches and Novel Drug Development. Frieder, A., Fersh, M., Hainline, R., et al.[2023]

Postpartum depression (PPD) is linked to lower levels of progesterone-derived neurosteroids, which help reduce anxiety and depression after childbirth.

Neurosteroid replacement therapy (NRT) using brexanolone, which modulates GABA-A receptors, shows potential as a rapid treatment for PPD, offering a different mechanism of action compared to traditional antidepressants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroendocrine insights into neurosteroid therapy for postpartum depression. Reddy, DS.[2023]

Brexanolone injection significantly reduced depression scores in women with moderate to severe post-partum depression compared to placebo, showing a clinically meaningful effect within 60 hours of treatment.

The treatment demonstrated a rapid onset of action and a durable response, although some patients experienced adverse events like headache and dizziness, indicating a need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials. Meltzer-Brody, S., Colquhoun, H., Riesenberg, R., et al.[2021]

A pharmacokinetic analysis of four breastfeeding women showed that ketamine and its metabolites are present in breast milk at low levels that decline rapidly within 12 hours after administration.

The mean relative infant dose (RID) of ketamine from two different doses (0.5 mg/kg and 1.0 mg/kg) was found to be 0.650% and 0.766%, respectively, suggesting that ketamine may be used cautiously in breastfeeding women with postpartum emotional disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women: Quantification of Ketamine and Metabolites. Wolfson, P., Cole, R., Lynch, K., et al.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of Postpartum Depression: Current Approaches and Novel Drug Development. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Neuroendocrine insights into neurosteroid therapy for postpartum depression. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women: Quantification of Ketamine and Metabolites. [2023]