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NCT05870540 | ACTIVE NOT 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 , with a Open Label Extension, designed to investigate the efficacy and safety of BPL-003 combined with psychological support in patients with treatment resistant depression (TRD).

Condition or disease

Treatment Resistant Depression

Intervention/treatment

BPL-003

BPL-003

Phase

PHASE2

Detailed Description:

Approximately 200 eligible participants will receive a single dose of either low, medium, or high doses of BPL-003, given intranasally, with 8 weeks of follow up assessments. Following this participants may receive a second dose of either monophasic or biphasic dose of BPL-003, given intranasally, with another 8 weeks of follow up assessments. Psychological support will be given before, during and after each dosing.

Study Type : INTERVENTIONAL
Estimated Enrollment : 196 participants
Masking : TRIPLE
Masking Description : CORE: Quadruple masking: participant, Investigator, therapist, outcomes assessor and Sponsor. OLE: Open Label Extension.
Primary Purpose : TREATMENT
Official Title : A Quadruple Masked, Dose-Finding Study to Evaluate the Efficacy and Safety of Intranasal BPL-003, With Open Label Extension, in Patients With Treatment-Resistant Depression
Actual Study Start Date : 2023-09-14
Estimated Primary Completion Date : 2025-03-28
Estimated Study Completion Date : 2025-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. At least moderate major depressive disorder.
  • 2. 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.
  • 3. Hamilton Depression Rating Scale score ≥19 at Screening and Baseline.
  • 4. CGI-S ≥4 at Screening and Baseline.
  • 5. If currently taking antidepressant medications, willing and able to discontinue current antidepressants.
Exclusion Criteria
  • 1. Current or past history of schizophrenia, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder.
  • 2. Current personality disorders.
  • 3. First-degree family history of schizophrenia, bipolar disorder, delusional disorder, or schizoaffective disorder.
  • 4. Current alcohol or substance use disorder (other than caffeine or nicotine).
  • 5. 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.
  • 6. Suicidal ideation or behavior within the 12 months prior to the start of Screening or on Day 1 prior to dosing.
  • 7. Suicide attempt and/or self-injurious behavior within the last 12 months prior to Screening.
  • 8. Uncontrolled medical conditions e.g. hypo/hyperthyroidism, diabetes, renal failure.
  • 9. History or current uncontrolled hypertension.
  • 10. Seizure disorder or any seizure in the 2 years prior to Screening.
  • 11. Has clinically significant results on ECG during the Screening.
  • 12. 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.
  • 13. Female participants who are pregnant, lactating, or of childbearing potential and not willing to use adequate forms of contraception during the study.
  • 14. 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

NCT05870540

Please Choose a site

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

Not yet recruiting

United States, Albama

UAB School of Public Health, Department of Health Behavior

Birmingham, Albama, United States, 35209

Not yet recruiting

United States, Arkansa

Woodland Research Northwest

Rogers, Arkansa, United States, 72758

Not yet recruiting

United States, California

Kadima Neuropsychiatry Institute

San Diego, California, United States, 92037

Not yet recruiting

United States, California

San Francisco Insight and Integration Center

San Francisco, California, United States, 94114

Not yet recruiting

United States, California

Pacific Neuroscience Institute, Treatment and Research in Psychedelics (TRIP) Program

Santa Monica, California, United States, 90404

Not yet recruiting

United States, Colorado

Wholeness Center

Fort Collins, Colorado, United States, 80525

Not yet recruiting

United States, Florida

Segal Trials Center for Psychedelic and Cannabis Research

Lauderhill, Florida, United States, 33319

Not yet recruiting

United States, Georgia

Emory University, Brain Health Center, Department of Psychiatry and Behavioral Sciences

Atlanta, Georgia, United States, 30329

Not yet recruiting

United States, Georgia

CenExel ACMR

Atlanta, Georgia, United States, 30331

Not yet recruiting

United States, Georgia

CenExel iResearch

Decatur, Georgia, United States, 30030

Not yet recruiting

United States, Maryland

Sunstone Medical PC (Sunstone Therapies / Aquilino Cancer Center)

Rockville, Maryland, United States, 20850

Not yet recruiting

United States, Massachusetts

Boston Clinical Trials

Boston, Massachusetts, United States, 02131

Not yet recruiting

United States, New Jersey

CenExel HRI

Berlin, New Jersey, United States, 08009

Not yet recruiting

United States, New York

New York State Psychiatric Institute

New York, New York, United States, 10032

Not yet recruiting

United States, Oregon

Portland Psychotherapy

Portland, Oregon, United States, 97227

Not yet recruiting

United States, Texas

Insite clinical research

DeSoto, Texas, United States, 75115

Not yet recruiting

United States, Texas

AIM Trials

Plano, Texas, United States, 75093

Not yet recruiting

United States, Utah

Cedar Clinical Research

Draper, Utah, United States, 84020

Not yet recruiting

United States, Wisconsin

University of Wisconsin, Dept of Family Medicine & Community Health

Madison, Wisconsin, United States, 53705

Not yet recruiting

Australia, New South Wales

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia, 2050

Not yet recruiting

Australia, Victoria

Dept. of Psychiatry and School Psychological Sciences, Monash University

Clayton, Victoria, Australia, 3168

Not yet recruiting

Australia,

NeuroCentrix Research

Melbourne, Australia, 3053

Not yet recruiting

Australia,

Royal Melbourne Hospital, University of Melbourne

Parkville, Australia, 3050

Not yet recruiting

Germany,

Charité - University Medicine Berlin

Berlin, Germany, 10117

Not yet recruiting

Germany,

OVID Clinic, Augmented Psychotherapy

Berlin, Germany, 10247

Not yet recruiting

Germany,

Department of Psychiatry, University Hospital Frankfurt

Frankfurt am Main, Germany, 60528

Not yet recruiting

Germany,

Central Institute of Mental Health, Dept. of Molecular Neuroimaging

Mannheim, Germany, 68159

Not yet recruiting

Germany,

University Clinic for Psychiatry and Psychotherapy, Calwerstr. 14

Tubingen, Germany, 72076

Not yet recruiting

Poland,

Department of Psychiatry, UCK

Gdansk, Poland, 80-214

Not yet recruiting

Poland,

Center for Clinical Research Pi-House sp.z o.o.

Gdansk, Poland, 80-546

Not yet recruiting

Poland,

SPZOZ Central Clinical Hospital of the Medical University of Lodz

Lodz, Poland, 92-216

Not yet recruiting

Poland,

An inventive clinic

Tuszyn, Poland, 95-080

Not yet recruiting

Poland,

Department of Pharmacology and Physiology of CNS

Warsaw, Poland, 02-957

Not yet recruiting

Spain,

Hospital del Mar

Barcelona, Spain, 08003

Not yet recruiting

Spain,

St. John's Health Park

Barcelona, Spain, 08029

Not yet recruiting

Spain,

Hospital Clinic de Barcelona, Psychiatry and Psychology Dept.

Barcelona, Spain, 08036

Not yet recruiting

Spain,

HM Hospital Research Foundation

Madrid, Spain, 28050

Not yet recruiting

Spain,

Mental Health Center La Corredoria

Oviedo, Spain, 33011

Not yet recruiting

Spain,

San Juan Health Center

Salamanca, Spain, 37005

Not yet recruiting

United Kingdom,

NIHR Exeter Clinical Research Facility

Exeter, United Kingdom, EX2 5DW

Not yet recruiting

United Kingdom,

King's College London - Institute of Psychiatry, Psychology & Neuroscience (IoPPN) - Centre for Affective Disorders (CfAD)

London, United Kingdom, SE5 8AF

Not yet recruiting

United Kingdom,

Clerkenwell Health

London, United Kingdom, W1G 8DR