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BPL-003 Efficacy and Safety in Treatment Resistant Depression

CompletedPhase 2

Sponsor: Beckley Psytech Limited

Conditions: Treatment Resistant Depression

Interventions: BPL-003, BPL-003

Countries: United States, Australia, Germany, Poland, Spain, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (42)

Birmingham, Alabama, United States
Rogers, Arkansas, United States
San Diego, California, United States
San Francisco, California, United States
Santa Monica, California, United States
Fort Collins, Colorado, United States
Lauderhill, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Rockville, Maryland, United States
Boston, Massachusetts, United States
Berlin, New Jersey, United States
New York, New York, United States
Portland, Oregon, United States
DeSoto, Texas, United States
Plano, Texas, United States
Draper, Utah, United States
Madison, Wisconsin, United States
Sydney, New South Wales, Australia
Clayton, Victoria, Australia
Melbourne, Australia
Parkville, Australia
Berlin, Germany
Berlin, Germany
Frankfurt am Main, Germany
Mannheim, Germany
Tübingen, Germany
Gdansk, Poland
Gdansk, Poland
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