Skip to main content
OpenTrials
Completed

NCT Number: NCT05870540

BPL-003 Efficacy and Safety in Treatment Resistant Depression

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Treatment Resistant Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

Loading trial locations.

About this study

During the main part of the trial, approximately 200 eligible participants will receive a either a low (sub-therapeutic), medium, or high single dose of BPL-003, given intranasally, with 8 weeks of follow-up assessments.

Following this, participants may receive a second high dose of BPL-003 during the OLE, given intranasally as either a single spray or two sprays 10 minutes apart, with another 8 weeks of follow-up assessments.

Psychological support will be given before, during, and after each dose.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of TRD.
  • History consistent with TRD.
  • 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).
  • Willing and able to discontinue current antidepressants, if applicable.

Exclusion criteria

  • Other co-morbidities.

Treatment and study plan

BPL-003

Drug

A single dose administered intranasally

Primary outcomes

  1. Core: Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Day 29 (12 mg vs 0.3 mg BPL-003)

    Time frame: 4 weeks

    The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS was administered remotely throughout the trial by independent, centralized, qualified raters. The rater used the SIGMA to interview the participant, moving from broadly based questions about symptoms to more detailed questions that allowed the precise rating of symptom severity. The SIGMA provides structured probes to ensure standardization of administration and comprehensiveness of coverage of the 10 items of the scale. A higher MADRS score indicates more severe depression, with each item yielding a score of 0-6. Total overall scores therefore range from 0-60.

    The change from baseline in MADRS total score for 12 mg (high dose) vs 0.3 mg (low dose) BPL-003 at Day 29 was assessed.

  2. OLE: Number of Participants With Treatment-emergent Adverse Events in the OLE

    Time frame: 8 weeks

    The safety of a second dose of BPL-003 given with psychological support to participants with TRD was assessed by the number and percentage of participants with treatment-emergent adverse events.

Secondary outcomes

  1. Core: Change From Baseline in MADRS Total Score at Day 8 (12 mg vs 0.3 mg BPL-003)

    Time frame: 1 week

    The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS was administered remotely throughout the trial by independent, centralized, qualified raters. The rater used the SIGMA to interview the participant, moving from broadly based questions about symptoms to more detailed questions that allowed the precise rating of symptom severity. The SIGMA provides structured probes to ensure standardization of administration and comprehensiveness of coverage of the 10 items of the scale. A higher MADRS score indicates more severe depression, with each item yielding a score of 0-6. Total overall scores therefore range from 0-60.

    The change from baseline in MADRS total score for 12 mg (high dose) vs 0.3 mg (low dose) BPL-003 at Day 8 was assessed.

  2. Core: Change From Baseline in MADRS Total Score at Day 29 (8 mg vs 0.3 mg BPL-003)

    Time frame: 4 weeks

    The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS was administered remotely throughout the trial by independent, centralized, qualified raters. The rater used the SIGMA to interview the participant, moving from broadly based questions about symptoms to more detailed questions that allowed the precise rating of symptom severity. The SIGMA provides structured probes to ensure standardization of administration and comprehensiveness of coverage of the 10 items of the scale. A higher MADRS score indicates more severe depression, with each item yielding a score of 0-6. Total overall scores therefore range from 0-60.

    The change from baseline in MADRS total score for 8 mg (medium dose) vs 0.3 mg (low dose) BPL-003 at Day 29 was assessed.

  3. Core: Change From Baseline in MADRS Total Score at Day 8 (8 mg vs 0.3 mg BPL-003)

    Time frame: 1 week

    The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS was administered remotely throughout the trial by independent, centralized, qualified raters. The rater used the SIGMA to interview the participant, moving from broadly based questions about symptoms to more detailed questions that allowed the precise rating of symptom severity. The SIGMA provides structured probes to ensure standardization of administration and comprehensiveness of coverage of the 10 items of the scale. A higher MADRS score indicates more severe depression, with each item yielding a score of 0-6. Total overall scores therefore range from 0-60.

    The change from baseline in MADRS total score for 8 mg (medium dose) vs 0.3 mg (low dose) BPL-003 at Day 8 was assessed.

  4. Core: Number of Participants With Treatment-emergent Adverse Events in the Core Trial Period

    Time frame: 8 weeks

    The safety of BPL-003 given with psychological support to participants with TRD was assessed by the number and percentage of participants with treatment-emergent adverse events. Any clinically significant findings during the trial have been included as adverse events.

Interested in participating?

Completed

Looking for future studies?

Notify Me

Sponsors and collaborators

Lead sponsor

Beckley Psytech Limited

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 23, 2023
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.