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Completed
NCT05870540
BPL-003 Efficacy and Safety in Treatment Resistant Depression
Conditions: Treatment Resistant Depression
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 196
Sponsor: Beckley Psytech Limited
Location: UAB School of Public Health, Department of Health Behavior Birmingham Alabama
Summary
This is a Phase 2 study randomized, quadruple-masked, multi-center trial with an open-label extension (OLE), designed to investigate the efficacy and safety of BPL-003 in patients with treatment resistant depression (TRD).
Eligibility Criteria
Inclusion criteria:
1. Diagnosis of TRD.
2. History consistent with TRD.
3. Current depressive episode which is at least moderate in severity (Hamilton Depression Rating Scale score is ≥19 and Clinical Global Impression-Severity score is ≥4).
4. Willing and able to discontinue current antidepressants, if applicable.
Exclusion criteria:
1\. Other co-morbidities.
Source: ClinicalTrials.gov (NCT05870540). StuddyBuddy aggregates publicly available trial information.
