At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years (males) or >1 year postmenopausal females
- ✓Diagnosed with recurrent MDD (DSM-5) confirmed by MINI
- ✓Current major depressive episode lasting 8 weeks to 36 months (DSM-5 and MINI confirmed)
- ✓Treatment-resistant: inadequate response (<50% improvement) to 1–3 courses of antidepressants in current episode
- ✕History or family history of sudden unexplained death or long QT syndrome
- ✕QTc ≥450 msec or QRS interval >120 msec on 12-lead ECG at Screening
- ✕Clinically significant cardiac abnormalities: torsades de pointes, bradyarrhythmias, or uncompensated heart failure
- ✕Lifetime history of bipolar I or II disorder, any psychotic disorder, PTSD, borderline personality disorder, antisocial personality disorder, OCD, eating disorder, intellectual disability, or pervasive developmental disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2a Multicenter Randomized Double-Blind Placebo-Controlled Study to Assess the Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing of REL-1017 as Adjunctive Therapy in the Treatment of Pts Diagnosed With MDD
In Brief
A Phase 2 clinical trial evaluating REL-1017 and Placebo for Depressive Disorder, Major and Depressive Disorder, Treatment-Resistant. Completed, enrolled 62 participants across 10 sites.
Detailed Summary
This a Phase 2a, multicenter, randomized, double-blind, placebo controlled 3 arm study to assess the safety and tolerability of multiple oral doses of REL-1017 25 mg and 50 mg as adjunctive therapy in the treatment of patients diagnosed with major depressive disorder (MDD). The patients will be adults with MDD who are diagnosed with a current MDE who have experienced an inadequate response to 1 to 3 courses of treatment with an antidepressant medication. This population will provide the opportunity to compare the safety and efficacy effects of treatment with an approved antidepressant in conjunction with REL-1017 versus the effects of an antidepressant alone. This study includes in-patient and out-patient periods.
Study Details
Timeline
Interventions
REL-1017 will be administered as an oral solution. Patients will continue to take the same, stabilized antidepressant medication that they were taking at screening throughout the course of the study.
Placebo will be administered as an oral solution. Patients will continue to take the same, stabilized antidepressant medication that they were taking at screening throughout the course of the study.