Postpartum DepressionPhase 2NCT06342310
RE104 Safety and Efficacy Study in Postpartum Depression
A Phase 2 study testing RE104 for Injection in people with Postpartum Depression, run by Reunion Neuroscience Inc at 38 sites in United States.
Trial summary
The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to-severe postpartum depression (PPD) as compared to active-control. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- RE104 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 38 sitesUnited States
- Study dates
- 14 Jun 2024to 16 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Is ≤15 months postpartum at Screening.
- Meet DSM-5 criteria for postpartum depression (PPD): experiencing a major depressive episode that began at any time starting at the beginning of the second trimester (≥14 weeks) of pregnancy through 4 weeks post delivery.
- Has a Hamilton Depression Scale (HAM-D) total score meeting severity threshold at Screening and Baseline.
- Is not using any psychotropic medications or psychotherapy for 30 days prior to Screening, OR are on an already stable/established regimen of SSRIs or psychotherapy for 30 days prior to Screening.
- Has ceased breastfeeding at Screening.
- Has a negative pregnancy test at Screening and Day 0 prior to study drug administration.
Who cannot join
- History or active postpartum psychosis per Investigator assessment.
- History of treatment-resistant depression within the current postpartum depressive episode.
- Has a significant risk of suicide.
- Active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder.
- Medically significant condition rendering unsuitability for the study .
- Has received electroconvulsive therapy (ECT) or transcranial magnetic stimulation within 90 days prior to Screening.
- Has used psychedelics such as psilocybin, ayahuasca, mescaline, or LSD (with the exception of cannabis) within 12 months prior to Screening.
- Has used or will need to use prohibited medications.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Reunion Investigational Site
Albuquerque, New Mexico, 87131
Reunion Investigational Site
Atlanta, Georgia, 30329
Reunion Investigational Site
Atlanta, Georgia, 30331
Reunion Investigational Site
Austin, Texas, 78712
Reunion Investigational Site
Austin, Texas, 78737
Reunion Investigational Site
Austin, Texas, 78759
Reunion Investigational Site
Baltimore, Maryland, 21205
Reunion Investigational Site
Birmingham, Alabama, 35209
Reunion Investigational Site
Boulder, Colorado, 80045
Reunion Investigational Site
Buffalo, New York, 14202
Reunion Investigational Site
Chapel Hill, North Carolina, 27599
Reunion Investigational Site
Charlottesville, Virginia, 22903
Reunion Investigational Site
Cleveland, Ohio, 44113
Reunion Investigational Site
Columbus, Ohio, 43210
Reunion Investigational Site
Decatur, Georgia, 30030
Reunion Investigational Site
Denver, Colorado, 80209
Reunion Investigational Site
Draper, Utah, 84020
Reunion Investigational Site
Honolulu, Hawaii, 96817
Reunion Investigational Site
Kansas City, Kansas, 66160
Reunion Investigational Site
Lauderhill, Florida, 33319
Reunion Investigational Site
Madison, Wisconsin, 53719
Reunion Investigational Site
Marietta, Georgia, 30060
Reunion Investigational Site
Monroe, North Carolina, 28112
Reunion Investigational Site
New York, New York, 10016
Reunion Investigational Site
New York, New York, 10026
Reunion Investigational Site
Novi, Michigan, 48377
Reunion Investigational Site
Plano, Texas, 75093
Reunion Investigational Site
Rockville, Maryland, 20850
Reunion Investigational Site
Salt Lake City, Utah, 84108
Reunion Investigational Site
San Antonio, Texas, 78229
Reunion Investigational Site
Santa Monica, California, 90404
Reunion Investigational Site
Savannah, Georgia, 31405
Reunion Investigational Site
Seattle, Washington, 98105
Reunion Investigational Site
Shreveport, Louisiana, 71106
Reunion Investigational Site
Springfield, Massachusetts, 01103
Reunion Investigational Site
Tampa, Florida, 33613
Reunion Investigational Site
Tucson, Arizona, 85724
Reunion Investigational Site
West Chester, Pennsylvania, 19380
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Patients With Postpartum Depression (PPD)
The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to-severe postpartum depression (PPD) as compared to active-control.
- Conditions
- Postpartum Depression
- Being tested
- RE104 for Injection
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RE104 for InjectionDrug
Single, subcutaneous dose of RE104 for Injection
| Study group | Role | What they receive |
|---|---|---|
| 1.5 mg RE104 | Active comparator | A single subcutaneous injection of 1.5 mg RE104 for Injection Receives: Drug: RE104 for Injection |
| 30 mg RE104 | Experimental | A single subcutaneous injection of 30 mg RE104 for Injection Receives: Drug: RE104 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity. The total score ranges from 0-60 with higher scores representing greater severity of depression.
Measured: Day 7
Secondary outcomes (7)
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity. The total score ranges from 0-60 with higher scores representing greater severity of depression.
Measured: Day 1, Day 14 and Day 28
RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS response (≥ 50 percent reduction in score from baseline)
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity. The total score ranges from 0-60 with higher scores representing greater severity of depression.
Measured: Day 7
RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS remission (score ≤ to 10)
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity. The total score ranges from 0-60 with higher scores representing greater severity of depression.
Measured: Day 7
RE104 30 mg versus RE104 1.5 mg Clinical Global Impression-Improvement (CGI-I)
The Clinical Global Impression - Improvement (CGI-I) Scale is a clinician-rated instrument that weighs the clinical impact of the identified symptom(s) on behavior and function and measures changes in psychopathology since the treatment was administered on a scale from 1 (very much improved) to 7 (very much worse).
Measured: Day 1, Day 7 and Day 28
RE104 30 mg versus RE104 1.5 mg change from baseline in CGI-Severity (CGI-S)
The Clinical Global Impression - Severity Scale is a clinician-rated instrument that grades severity of symptoms on a scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients).
Measured: Day 1, Day 7 and Day 28
RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)
The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.
Measured: Day 7
RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.
A treatment-emergent adverse event (TEAE) is defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a study drug.
Measured: From dosing through study completion (post-dose follow-up is for 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start14 Jun 2024
- Primary completion22 May 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reunion Neuroscience Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jasna Hocevar-Trnka, M.D., Study director, Reunion Neuroscience Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342310
- Sponsor's protocol ID
- RE104-201-PPD
- Status last verified
- May 2025
- First submitted
- 26 Mar 2024
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel-Group Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Patients With Postpartum Depression (PPD)
- ClinicalTrials.gov ID
- NCT06342310
- Acronym / sponsor ID
- RE104-201-PPD
- Conditions
- Postpartum Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Reunion Neuroscience IncIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to-severe postpartum depression (PPD) as compared to active-control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.5 mg RE104 | Active comparator | Drug: RE104 for InjectionA single subcutaneous injection of 1.5 mg RE104 for Injection |
| 30 mg RE104 | Experimental | Drug: RE104 for InjectionA single subcutaneous injection of 30 mg RE104 for Injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Is ≤15 months postpartum at Screening.
- Meet DSM-5 criteria for postpartum depression (PPD): experiencing a major depressive episode that began at any time starting at the beginning of the second trimester (≥14 weeks) of pregnancy through 4 weeks post delivery.
- Has a Hamilton Depression Scale (HAM-D) total score meeting severity threshold at Screening and Baseline.
- Is not using any psychotropic medications or psychotherapy for 30 days prior to Screening, OR are on an already stable/established regimen of SSRIs or psychotherapy for 30 days prior to Screening.
- Has ceased breastfeeding at Screening.
Key exclusion criteria (8 listed)
- History or active postpartum psychosis per Investigator assessment.
- History of treatment-resistant depression within the current postpartum depressive episode.
- Has a significant risk of suicide.
- Active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder.
- Medically significant condition rendering unsuitability for the study .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RE104 for InjectionSingle, subcutaneous dose of RE104 for Injection | Drug | 1.5 mg RE104, 30 mg RE104 |
Primary outcome
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score
Time frame: Day 7
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity. The total score ranges from 0-60 with higher scores representing greater severity of depression.
7 secondary outcomes
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score
Time frame: Day 1, Day 14 and Day 28
RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS response (≥ 50 percent reduction in score from baseline)
Time frame: Day 7
RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS remission (score ≤ to 10)
Time frame: Day 7
RE104 30 mg versus RE104 1.5 mg Clinical Global Impression-Improvement (CGI-I)
Time frame: Day 1, Day 7 and Day 28
RE104 30 mg versus RE104 1.5 mg change from baseline in CGI-Severity (CGI-S)
Time frame: Day 1, Day 7 and Day 28
RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Day 7
RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.
Time frame: From dosing through study completion (post-dose follow-up is for 28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No. Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jasna Hocevar-Trnka, M.D. study director
Reunion Neuroscience Inc
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RE104 for Injection in people with Postpartum Depression, run by Reunion Neuroscience Inc at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.