Major Depressive Disorder (MDD)
Conditions
Keywords
SUVN-911, α4β2, Ropanicant, MDD
Brief summary
The primary objective is to evaluate the efficacy of Ropanicant at two different dosage levels compared to placebo in patients with Major Depressive Disorder (MDD).
Detailed description
This is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of Ropanicant versus placebo in patients with MDD. The study will be conducted at multiple centers located in the US. This study consists of a 4-weeks screening period, 6-weeks treatment period, and a 2-weeks follow-up period. Approximately 195 patients will be randomly assigned to receive Ropanicant Dose Level 1 bid or Dose Level 2 bid, or placebo bid for 6 weeks in a ratio of 1:1:1 (65 patients in each treatment group).
Interventions
DRUGRopanicant
Tablet dosage form, twice a day
DRUGPlacebo
Matching placebo tablets, twice a day
Sponsors
Suven Life Sciences Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for MDD without psychotic features based on the Mini International Neuropsychiatric Interview (MINI) with a current major depressive episode of at least 4 weeks of duration but no longer than 12 months. * Patients must have a Clinical Global Impression-Severity (CGI-S) score of ≥4. * Patients must have a Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D) score of ≥20. * Patients must have a Snaith-Hamilton Pleasure Scale (SHAPS) score of ≥20. * Patients must have vision and hearing (corrected if needed) sufficient to comply with the testing procedures.
Exclusion criteria
* Patients who meet criteria for treatment-resistant depression (TRD) during the current major depressive episode, which is defined as being nonresponders (\<50% of symptom improvement) to 2 or more depression treatment periods of adequate dose and duration. * Patients not in good general health with clinically significant abnormalities as assessed by the investigator and determined by physical examination results, neurological examination results, ECG results, or laboratory assessments. * Female patients who are pregnant, planning to become pregnant during the study or within 30 days after the last administration of study drug, or breastfeeding. * Patients with bradycardia (\<50 bpm) or tachycardia (\>100 bpm) on the ECG results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6 | Baseline to Week 6 | The MADRS is a clinician-rated scale to assess depressive symptoms which consists from 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Week 6 | Baseline to Week 6 | The CGI-S will be used to rate the severity of each patient's illness related to depressive symptoms on a 7-point scale, which includes the following gradations: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill. |
Countries
United States
Outcome results
None listed