Major Depressive Disorder
Conditions
Keywords
SUVN-911, Phase-2, MDD, Depression, Open label
Brief summary
This is an open-label, parallel-group study to evaluate the safety and efficacy of Ropanicant in participants with moderate to severe Major Depressive Disorder (MDD).
Detailed description
Approximately 36 participants will be randomly assigned to receive Ropanicant either Ropanicant 45 mg once a day (QD), Ropanicant 30 mg twice a day (BID), or Ropanicant 45 mg BID for 2 weeks, in a ratio of 1:1:1 (12 participants in each treatment group). Following a screening period of up to 4 weeks, the participants will be treated for 2 weeks.
Interventions
DRUGRopanicant
Tablet
Sponsors
Suven Life Sciences Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants must meet the DSM-5 criteria for MDD without psychotic features and diagnosis confirmed by the Mini-International Neuropsychiatric Interview (MINI). * Participants with a current major depressive episode of at least 4 weeks of duration prior to the screening visit. * Participants must have an MADRS score of ≥25 at the screening and the baseline visits. * Participants must have a score of ≥4 on Clinical Global Impression - Severity (CGI-S) Scale at the screening and the baseline visits.
Exclusion criteria
* Participants who meet criteria for treatment-resistant depression during the current major depressive episode, which will be defined as being non-responders (less than 50% of symptom improvement) to 2 or more depression treatment periods of adequate dose and duration as defined by the Massachusetts General Hospital (MGH) Antidepressant Treatment Response Questionnaire (ATRQ). * Participants taking antidepressant treatment (SSRIs and SNRIs) or any medication that is contraindicated with the use of monoamine oxidase inhibitors (eg, opioids, stimulants) within 2 weeks (or 5 half-lives, whichever is longer) prior to baseline and until the end of study visit. * Participants who do not agree to avoid tyramine rich diet from the start of dosing and until 2 weeks following last study drug administration. * Participants who are habitual smokers or using nicotine products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | From Screening to Day 21 | Participants with at least one Treatment-emergent adverse events (TEAEs) reported during the duration of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Åsberg Depression Rating Scale (MADRS) Score | From Baseline to Day 14 | Change from the baseline to the MADRS total score. The MADRS is a clinician-rated scale to assess depressive symptoms which consists of 10 items. The time frame for this scale is the past 7 days. Each item is scored on 7-point scale (0 \[absence of symptoms\] to 6 \[severe\]). The total score is the sum of 10 items and can take range from 0 to 60. A higher score represents a higher severity of the level of depression. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age, Continuous | 44.9 years STANDARD_DEVIATION 13.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Montgomery-Asberg Depression Rating Scale (MADRS) | 32.1 units on a scale STANDARD_DEVIATION 4.58 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 6 / 14 | 6 / 13 | 6 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 | 0 / 13 |
Outcome results
None listed