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RE104 Safety and Efficacy Study in Postpartum Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06342310
Recruitment Status : Not yet recruiting
First Posted : April 2, 2024
Last Update Posted : April 3, 2024
Sponsor:
Information provided by (Responsible Party):
Reunion Neuroscience Inc

Study Description
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Brief 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-placebo.

Condition or disease Intervention/treatment Phase
Postpartum Depression Drug: RE104 for Injection Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : May 2024
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1.5 mg RE104
A single subcutaneous injection of 1.5 mg RE104 for Injection
 Drug: RE104 for Injection
Single, subcutaneous dose of RE104 for Injection
Experimental: 30 mg RE104
A single subcutaneous injection of 30 mg RE104 for Injection
 Drug: RE104 for Injection
Single, subcutaneous dose of RE104 for Injection


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score [ Time Frame: Day 1, Day 14 and Day 28 ]
    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.

  2. 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 ]
    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.

  3. RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS remission (score ≤ to 10) [ 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.

  4. RE104 30 mg versus RE104 1.5 mg Clinical Global Impression-Improvement (CGI-I) [ Time Frame: Day 1, Day 7 and Day 28 ]
    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).

  5. 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 ]
    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).

  6. 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 ]
    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.

  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) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is ≤12 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06342310


Contacts
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Contact: Jasna Hocevar-Trnka, M.D. 1-888-880-REUN info@reunionneuro.com

Sponsors and Collaborators
Reunion Neuroscience Inc
Investigators
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Study Director: Jasna Hocevar-Trnka, M.D. Reunion Neuroscience Inc
More Information
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Responsible Party: Reunion Neuroscience Inc
ClinicalTrials.gov Identifier: NCT06342310    
Other Study ID Numbers: RE104-201-PPD
First Posted: April 2, 2024    Key Record Dates
Last Update Posted: April 3, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
 Mental Disorders
Puerperal Disorders
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases