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).
Approximately 36 participants will be randomly assigned to receive ropanicant either 45 mg qd, 30 mg bid, or 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Tablet
Clinical Innovations, Inc
Bellflower, California, United States
NRC Research Institute
Orange, California, United States
Collaborative Neuroscience Research, LLC
Torrance, California, United States
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Frequency and severity of adverse events, treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
Time frame: From Screening to Day 21
Montgomery-Åsberg Depression Rating Scale (MADRS) score.
Change from the baseline to the MADRS total score. 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.
Time frame: From Baseline to Day 14
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Innovative Clinical Research, Inc.
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