Severe Postpartum DepressionPhase 2NCT06057012
A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD)
A Phase 2 study testing BRII-296 and Depo Medrol in people with Severe Postpartum Depression, run by Brii Biosciences Limited at 11 sites in United States.
Trial summary
The primary purpose of this study is to evaluate the safety and tolerability of BRII-296 administered by 2 intramuscular injections, administered with Depo Medrol as assessed by the incidence of adverse events, changes from baseline in vital signs, pulse oximetry, clinical laboratory evaluations, electrocardiograms… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Severe Postpartum Depression
- What is being tested?
- BRII-296 and Depo Medrol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 11 sitesUnited States
- Study dates
- 29 Sep 2023to 13 Mar 2024
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participant either must have ceased lactating at screening or is still lactating actively breastfeeding at screening , must agree temporarily cease giving breast milk to her infant(s)
- Participant has had a Major Depressive Episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Participant was <12 months postpartum
- Participant is amenable to intramuscular administration of investigational product on Day 1 and remaining inpatient until at least Day 4
Who cannot join
- Active psychosis
- Attempted suicide associated with current episode of postpartum depression
- Medical history of seizures
- Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Synexus Clinical Research US, Inc.
Atlanta, Georgia, 30328
Cenexel ACMR Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Clinical Research Center of Florida
Boynton Beach, Florida, 33435
Aventura Clinical Research, LLC
Davie, Florida, 33328
iResearch Atlanta, LLC
Decatur, Georgia, 30030
Research Carolina Elite
Denver, North Carolina, 28037
North Texas Clinical Trials
Fort Worth, Texas, 76104
Maximos OB/GYN
League City, Texas, 77573
South Florida Research Phase I-IV Inc
Miami Springs, Florida, 33166
Cenexel CNR
Sherman Oaks, California, 91403
CenExel CNS-Torrance
Torrance, California, 90504
About this study
Official title: A Phase 2a, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Descriptive Efficacy of BRII-296 in Adults With Severe Postpartum Depression (PPD)
The primary purpose of this study is to evaluate the safety and tolerability of BRII-296 administered by 2 intramuscular injections, administered with Depo Medrol as assessed by the incidence of adverse events, changes from baseline in vital signs, pulse oximetry, clinical laboratory evaluations, electrocardiograms (ECGs), Stanford Sleepiness Scale (SSS), Glasgow Coma Scale (GCS) in conjunction with clinical assessment, and suicidal ideation using the Columbia Suicide Severity Rating Scale (C-SSRS).
- Conditions
- Severe Postpartum Depression
- Being tested
- BRII-296, Depo Medrol
- Keywords
- Treatment
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRII-296Drug
BRII-296 will be given via intramuscular injection.
Depo MedrolDrug
Depo Medrol will be given via intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| BRII-296 + Depo Medrol | Experimental | Participants will receive BRII-296 600 milligram (mg) and Depo Medrol (80 milligram per milliliter [mg/mL]) on Day 1 as a combination therapy. Receives: Drug: BRII-296; Drug: Depo Medrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: From the first dose of study drug up to Day 45
Number of Participants With Adverse Events (AEs) According to Severity
Severity will be assessed according to the following scale: Mild, moderate and severe.
Measured: From the first dose of study drug up to Day 45
Number of Participants With Change From Baseline in Clinically Significant Vital Sign Parameters
Measured: Baseline up to Day 45
Number of Participants With Abnormal Electrocardiogram (ECG) Parameters
Measured: From the first dose of study drug up to Day 45
Number of Participants With Change From Baseline in Clinically Significant Clinical Laboratory Evaluations
Measured: From the first dose of study drug up to Day 45
Number of Participants With Columbia-Suicide Severity Rating Scale (C-SSRS) Responses
The suicidal ideation and behavior will be monitored during the study using the C-SSRS. This scale consists of a "Baseline/Screening" version that assesses the lifetime and recent experience of the participant with suicidal ideation and behavior, and a "Since Last Visit" version that focuses on suicidality since the last study visit. The C-SSRS includes "yes" or "no" responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe).
Measured: Baseline up to Day 45
Change From Baseline in Glasgow Coma Scale (GCS) Score
The GCS is a simple measure of the depth and duration of impaired consciousness and coma. 3 domains of alertness will be evaluated: eye opening response (scored 1 [None] to 4 [Spontaneous]), verbal response (scored 1 [None] to 5 [Oriented]), and motor response (scored 1 [None] to 6 [Obeys commands]). Total scores range from 3 to 15, with 15 reflecting full alertness.
Measured: Baseline up to Day 45
Change From Baseline in Stanford Sleepiness Scale (SSS) Score
The SSS is a participant-rated measure of sleepiness, frequently used for both research and clinical purposes. The SSS evaluates sleepiness at specific moments in time. Respondents rate their current degree of sleepiness and alertness on a scale of 1 to 7, where the lowest score of '1' indicates the respondent is 'feeling active, vital, alert, or wide awake' and the highest score of '7' indicates the respondent is 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'.
Measured: Baseline up to Day 45
PK of Brexanolone: Maximum Observed Plasma Concentration (Cmax)
Measured: Day 1- Day 45
PK of Brexanolone: Time to Reach Cmax (Tmax)
Measured: Day 1- Day 45
PK of Brexanolone: Area Under the Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last)
Measured: Day 1- Day 45
PK of Brexanolone: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf)
Measured: Day 1- Day 45
PK of Brexanolone: Apparent Terminal Elimination Half-life (t½)
Measured: Day 1- Day 45
PK of Brexanolone: Apparent Clearance (CL/F)
Measured: Day 1- Day 45
PK of Brexanolone: Volume of Distribution (Vz/F)
Measured: Day 1- Day 45
Secondary outcomes (8)
Change From Baseline in Hamilton Depression Rating Scale (HAM-D) Total Score
The 17-item HAM-D will be used to rate the severity of depression in participants who are already diagnosed as depressed. The 17-item HAM-D is comprised of individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, and worthless), feelings of guilt, suicide, insomnia (early, middle, and late), work and activities, retardation (slowness of thought and speech, impaired ability to concentrate, and decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. The total scores range from 0-52. Higher score indicates more depression.
Measured: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
Number of Participants With HAM-D Response
Response is defined as >=50 percent (%) reduction from baseline in HAM-D total score. The HAM-D is a 17-item scale used to rate the severity of depression in participants who are already diagnosed as depressed. The total scores of HAM-D range from 0-52. Higher score indicates more depression.
Measured: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
Number of Participants With HAM-D Remission
Remission is defined as <=7.0 HAM-D total score. The HAM-D is a 17-item scale used to rate the severity of depression in participants who are already diagnosed as depressed. The total scores of HAM-D range from 0-52. Higher score indicates more depression.
Measured: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Response
The CGI-I item employs a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The clinician will rate the participant's total improvement, whether or not it is due entirely to investigational product treatment. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. CGI-I response will be defined as having a CGI-I score of "very much improved" or "much improved."
Measured: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Response
The CGI-S item uses a 7- point Likert scale to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating. Choices include: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = extremely ill.
Measured: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
Change From Baseline in HAM-D Bech-6 Subscale Score
The HAM-D Bech 6 subscale score is calculated as the sum of the following six items: Item # 1 (depressed mood), Item # 2 (feelings of guilt), Item # 7 (work and activities), Item # 8 (retardation), Item # 10 (anxiety psychic), and Item # 13 (general somatic symptoms). Each item is scored in a range of 0 to 2 or 0 to 4, with higher scores indicating a greater degree of depression. The scores will be transformed to a 100-point scale with a higher score indicating a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
Measured: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
Change From Baseline in HAM-D Individual Item Score
The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
Measured: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
The 14-item HAM-A will be used to rate the severity of symptoms of anxiety. Each of the 14 items is defined by a series of symptoms and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scoring for the HAM-A is calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56, where less than (<) 17 indicates mild severity, 18 to 24 mild to moderate severity, and 25 to 30 moderate to severe severity. The HAM-A total score will be calculated as the sum of the 14 individual item scores.
Measured: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start29 Sep 2023
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brii Biosciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057012
- Sponsor's protocol ID
- BRII-296-002
- Status last verified
- Jan 2025
- First submitted
- 21 Sep 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Descriptive Efficacy of BRII-296 in Adults With Severe Postpartum Depression (PPD)
- ClinicalTrials.gov ID
- NCT06057012
- Acronym / sponsor ID
- BRII-296-002
- Conditions
- Severe Postpartum Depression
- Keywords
- Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Brii Biosciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 28 Sep 2023 (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 primary purpose of this study is to evaluate the safety and tolerability of BRII-296 administered by 2 intramuscular injections, administered with Depo Medrol as assessed by the incidence of adverse events, changes from baseline in vital signs, pulse oximetry, clinical laboratory evaluations, electrocardiograms (ECGs), Stanford Sleepiness Scale (SSS), Glasgow Coma Scale (GCS) in conjunction with clinical assessment, and suicidal ideation using the Columbia Suicide Severity Rating Scale (C-SSRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BRII-296 + Depo Medrol | Experimental | Drug: BRII-296, Drug: Depo MedrolParticipants will receive BRII-296 600 milligram (mg) and Depo Medrol (80 milligram per milliliter [mg/mL]) on Day 1 as a combination therapy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant either must have ceased lactating at screening or is still lactating actively breastfeeding at screening , must agree temporarily cease giving breast milk to her infant(s)
- Participant has had a Major Depressive Episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Participant was <12 months postpartum
- Participant is amenable to intramuscular administration of investigational product on Day 1 and remaining inpatient until at least Day 4
Key exclusion criteria (4 listed)
- Active psychosis
- Attempted suicide associated with current episode of postpartum depression
- Medical history of seizures
- Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder
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 |
|---|---|---|
| BRII-296BRII-296 will be given via intramuscular injection. | Drug | BRII-296 + Depo Medrol |
| Depo MedrolDepo Medrol will be given via intramuscular injection. | Drug | BRII-296 + Depo Medrol |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From the first dose of study drug up to Day 45
Number of Participants With Adverse Events (AEs) According to Severity
Time frame: From the first dose of study drug up to Day 45
Severity will be assessed according to the following scale: Mild, moderate and severe.
Number of Participants With Change From Baseline in Clinically Significant Vital Sign Parameters
Time frame: Baseline up to Day 45
Number of Participants With Abnormal Electrocardiogram (ECG) Parameters
Time frame: From the first dose of study drug up to Day 45
Number of Participants With Change From Baseline in Clinically Significant Clinical Laboratory Evaluations
Time frame: From the first dose of study drug up to Day 45
Number of Participants With Columbia-Suicide Severity Rating Scale (C-SSRS) Responses
Time frame: Baseline up to Day 45
The suicidal ideation and behavior will be monitored during the study using the C-SSRS. This scale consists of a "Baseline/Screening" version that assesses the lifetime and recent experience of the participant with suicidal ideation and behavior, and a "Since Last Visit" version that focuses on suicidality since the last study visit. The C-SSRS includes "yes" or "no" responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe).
Change From Baseline in Glasgow Coma Scale (GCS) Score
Time frame: Baseline up to Day 45
The GCS is a simple measure of the depth and duration of impaired consciousness and coma. 3 domains of alertness will be evaluated: eye opening response (scored 1 [None] to 4 [Spontaneous]), verbal response (scored 1 [None] to 5 [Oriented]), and motor response (scored 1 [None] to 6 [Obeys commands]). Total scores range from 3 to 15, with 15 reflecting full alertness.
Change From Baseline in Stanford Sleepiness Scale (SSS) Score
Time frame: Baseline up to Day 45
The SSS is a participant-rated measure of sleepiness, frequently used for both research and clinical purposes. The SSS evaluates sleepiness at specific moments in time. Respondents rate their current degree of sleepiness and alertness on a scale of 1 to 7, where the lowest score of '1' indicates the respondent is 'feeling active, vital, alert, or wide awake' and the highest score of '7' indicates the respondent is 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'.
PK of Brexanolone: Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1- Day 45
PK of Brexanolone: Time to Reach Cmax (Tmax)
Time frame: Day 1- Day 45
PK of Brexanolone: Area Under the Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last)
Time frame: Day 1- Day 45
PK of Brexanolone: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf)
Time frame: Day 1- Day 45
PK of Brexanolone: Apparent Terminal Elimination Half-life (t½)
Time frame: Day 1- Day 45
PK of Brexanolone: Apparent Clearance (CL/F)
Time frame: Day 1- Day 45
PK of Brexanolone: Volume of Distribution (Vz/F)
Time frame: Day 1- Day 45
8 secondary outcomes
Change From Baseline in Hamilton Depression Rating Scale (HAM-D) Total Score
Time frame: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
Number of Participants With HAM-D Response
Time frame: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
Number of Participants With HAM-D Remission
Time frame: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Response
Time frame: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Response
Time frame: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
Change From Baseline in HAM-D Bech-6 Subscale Score
Time frame: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
Change From Baseline in HAM-D Individual Item Score
Time frame: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Time frame: Baseline and at Days 2, 3, 4, 8, 15, 30, and 45
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 27 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 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 BRII-296 and Depo Medrol in people with Severe Postpartum Depression, run by Brii Biosciences Limited at 11 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 4 inclusion and 4 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 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: From the first dose of study drug up to Day 45). The study lists 15 primary outcomes in all. 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 27 Jan 2025.