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NCT05870540 | Recruiting | Treatment Resistant Depression


BPL-003 Efficacy and Safety in Treatment Resistant Depression
Sponsor:

Beckley Psytech Limited

Brief Summary:

This is a Phase 2 study randomized, quadruple masked, multi-center study designed to investigate the efficacy and safety of a single dose of BPL-003 combined with psychological support in patients with treatment resistant depression (TRD).

Condition or disease

Treatment Resistant Depression

Intervention/treatment

BPL-003

Phase

Phase 2

Detailed Description:

Approximately 225 eligible participants will be receive a single dose of either low, medium, or high doses BPL-003, given intranasally, with 8 weeks of follow-up assessments. Psychological support will be given before, during and after dosing.

Study Type : Interventional
Estimated Enrollment : 225 participants
Masking: Triple
Masking Description: Quadruple masking: participant, Investigator, therapist, outcomes assessor and Sponsor
Primary Purpose: Treatment
Official Title: A Quadruple Masked, Dose-Finding Study to Evaluate the Efficacy and Safety of Intranasal BPL-003 in Patients With Treatment Resistant Depression
Actual Study Start Date : September 14, 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : December 2024
Arm Intervention/treatment

Experimental: Low dose

Active placebo comparator

Drug: BPL-003

Experimental: Medium dose

Drug: BPL-003

Experimental: High dose

Drug: BPL-003

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • At least moderate major depressive disorder.
  • Diagnosed with TRD defined as failure to respond to an adequate dose and duration of at least 2 pharmacological treatments based on the MGH ATRQ assessment.
  • Hamilton Depression Rating Scale score ≥19 at Screening and Baseline.
  • CGI-S ≥4 at Screening and Baseline.
  • If currently taking antidepressant medications, willing and able to discontinue current antidepressants.
Exclusion Criteria
  • Current or past history of schizophrenia, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder.
  • Current personality disorders.
  • First-degree family history of schizophrenia, bipolar disorder, delusional disorder, or schizoaffective disorder.
  • Current alcohol or substance use disorder (other than caffeine or nicotine).
  • A participant who at any time has been unresponsive to ketamine, esketamine, an adequate course of treatment with electroconvulsive therapy, or has received vagal nerve stimulation or deep brain stimulation.
  • Suicidal ideation or behavior within the 12 months prior to the start of Screening or on Day 1 prior to dosing.
  • Suicide attempt and/or self-injurious behavior within the last 12 months prior to Screening.
  • Uncontrolled medical conditions e.g. hypo/hyperthyroidism, diabetes, renal failure.
  • History or current uncontrolled hypertension.
  • Seizure disorder or any seizure in the 2 years prior to Screening.
  • Has clinically significant results on ECG during the Screening.
  • Any nasal obstruction, blockage, or symptoms of congestion at the time of dosing that in the investigator's opinion may interfere with the administration of the study medication.
  • Female participants who are pregnant, lactating, or of childbearing potential and not willing to use adequate forms of contraception during the study.
  • Male participants who are sexually active and not willing to use adequate forms of contraception during the study.

BPL-003 Efficacy and Safety in Treatment Resistant Depression

Location Details


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BPL-003 Efficacy and Safety in Treatment Resistant Depression

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, Alabama

UAB School of Public Health, Department of Health Behavior

Birmingham, Alabama, United States, 35222

Recruiting

United States, Arkansas

Woodland Research Northwest

Rogers, Arkansas, United States, 72758

Recruiting

United States, Colorado

Wholeness Center

Fort Collins, Colorado, United States, 80525

Recruiting

United States, Florida

Segal Trials Center for Psychedelic and Cannabis Research

Lauderhill, Florida, United States, 33319

Recruiting

United States, Maryland

Sunstone Medical PC (Sunstone Therapies / Aquilino Cancer Center)

Rockville, Maryland, United States, 20850

Not yet recruiting

United States, New York

New York State Psychiatric Institute

New York, New York, United States, 10032

Recruiting

United States, Oregon

Portland Psychotherapy

Portland, Oregon, United States, 97227

Recruiting

United States, Texas

AIM Trials

Plano, Texas, United States, 75093

Recruiting

United States, Utah

Cedar Clinical Research

Draper, Utah, United States, 84020

Recruiting

Australia, New South Wales

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia, 2050

Recruiting

Australia, Victoria

Dept. of Psychiatry and School Psychological Sciences, Monash University

Clayton, Victoria, Australia, 3168

Recruiting

Australia,

Royal Melbourne Hospital, University of Melbourne

Parkville, Australia, 3050

Recruiting

Germany,

Charité - Universitätsmedizin Berlin

Berlin, Germany, 10117

Recruiting

Germany,

Central Institute of Mental Health, Dept. of Molecular Neuroimaging

Mannheim, Germany, 68159

Recruiting

Germany,

Universitätsklinik für Psychiatrie und Psychotherapie, Calwerstr. 14

Tubingen, Germany, 72076

Recruiting

Poland,

Department of Psychiatry, UCK

Gdansk, Poland, 80-214

Recruiting

Poland,

Centrum Badań Klinicznych PI-House sp. z o.o.

Gdansk, Poland, 80-546

Recruiting

Poland,

Klinika Inventiva

Tuszyn, Poland, 95-080

Recruiting

Spain,

Hospital del Mar

Barcelona, Spain, 08003

Recruiting

Spain,

Parc Sanitari Sant Joan de Deu HD Numancia

Barcelona, Spain, 08029

Recruiting

Spain,

Hospital Clinic de Barcelona, Psychiatry and Psychology Dept.

Barcelona, Spain, 08036

Recruiting

Spain,

Fundación de Investigación HM Hospital

Madrid, Spain, 28050

Recruiting

Spain,

Centro de Salud Mental La Corredoria

Oviedo, Spain, 33011

Recruiting

Spain,

Centro Salud San Juan

Salamanca, Spain, 37005

Recruiting

United Kingdom,

Clerkenwell Health

London, United Kingdom, W1G 8DR

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