BPL-003 for Treatment Resistant Depression

Recruiting at 45 trial locations

Overseen By Beckley Psytech Ltd

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Beckley Psytech Limited

Must not be taking: Antidepressants

Disqualifiers: Schizophrenia, Bipolar, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

196 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a nasal spray drug called BPL-003 along with counseling for people whose depression doesn't get better with usual treatments. The drug aims to quickly improve mood, and counseling helps provide emotional support.

Will I have to stop taking my current medications?

If you are currently taking antidepressant medications, you must be willing and able to stop taking them to participate in this trial.

Research Team

VP & Head of Clinical Development

Principal Investigator

Beckley Psytech Ltd

Eligibility Criteria

This trial is for adults with treatment-resistant depression, which means their condition didn't improve after trying at least two different antidepressants. They must have a certain level of depression severity and be willing to stop current antidepressants. People can't join if they're pregnant or not using contraception, have uncontrolled medical conditions like heart issues or diabetes, nasal blockages, severe psychiatric disorders other than depression, recent suicidal behavior, or haven’t responded to similar treatments before.

Inclusion Criteria

If currently taking antidepressant medications, willing and able to discontinue current antidepressants

I have treatment-resistant depression after trying at least 2 different medications.

I have been diagnosed with moderate to severe depression.

Exclusion Criteria

Suicide attempt and/or self-injurious behavior within the last 12 months prior to Screening

Has clinically significant results on ECG during the Screening

Current personality disorders

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intranasal dose of BPL-003 with psychological support

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• BPL-003

Trial Overview The study tests BPL-003's effectiveness and safety in treating resistant depression when given once alongside psychological support. It’s a Phase 2 trial where participants are randomly assigned and neither they nor the researchers know who receives the actual drug versus a placebo (quadruple masked).

Participant Groups

Group I: Monophasic Experimental Treatment 1 Intervention

Group II: Medium dose Experimental Treatment 1 Intervention

Group III: Low dose Experimental Treatment 1 Intervention

Active placebo comparator

Group IV: High dose Experimental Treatment 1 Intervention

Group V: Biphasic Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Beckley Psytech Limited

Lead Sponsor

Trials

7

Recruited

490+