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Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 24, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT02153502). This is a study registration, not published results. Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 206 participants (ACTUAL). Conditions: Depressive Disorder, Treatment-Resistant. Interventions: DRUG: AVP-786 (d6-dextromethorphan hydrobromide and quinidine sulfate combination); DRUG: Placebo. Primary outcome measures: Montgomery-Ǻsberg Depression Rating Scale (MADRS) total score , Visit 5 (Day 70) Week 10. Brief summary: The objectives of this 10-week study are to evaluate the efficacy, safety, and tolerability of AVP 786 as an adjunctive therapy compared with placebo in patients with major depressive disorder (MDD) who have shown an inadequate response to standard antidepressant treatment. A secondary objective of this study is to assess the pharmacokinetics (PK) of AVP-786 and potential correlations with pharmacodynamic effects.