Overview
An open-label, multi-centre, Phase 2a study to evaluate the safety, tolerability, and pharmacodynamics of one and two doses of intranasal BPL-003 combined with psychological support, in patients with treatment resistant depression when administered as monotherapy or as adjunctive therapy with defined SSRIs (citalopram, escitalopram, sertraline or fluoxetine).
Description
Part 1: Up to 32 patients, across 2 parallel arms (Arms A and Arms B) will receive one of two single doses of BPL-003, given intranasally, with 12 weeks of follow-up assessments.
Part 2: Up to 32 patients, across 2 parallel arms (Arms A and Arms B) will receive two doses of BPL-003, given intranasally, with 10 weeks of follow-up assessments.
Psychological support will be given before, during and after dosing in Part 1 and Part 2.
Eligibility
Inclusion Criteria:
- Diagnosed with Major Depressive Disorder.
- Diagnosed with TRD defined as failure to respond to an adequate dose and duration of at least 2 pharmacological treatments in the past 5 years prior to screening, at least one of which is during the current episode.
- Montgomery-Asberg Depression Rating Scale score ≥24 at Screening.
- Clinical Global Impression - Severity ≥4 at Screening.
- Willing and able to discontinue current pharmacological anti-depressant therapy.
- On current stable dose of pharmacological antidepressant therapy limited to one of 4 SSRIs (Arm B), i.e. either citalopram, escitalopram, sertraline or fluoxetine.
Exclusion Criteria:
- Current or 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, personality disorders 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 with the intent to act or suicidal behaviour within the 12 months prior to the start of Screening or on Day 1 prior to dosing.
- Suicide attempt and/or self-injurious behaviour within the last 12 months prior to Screening.
- Uncontrolled medical conditions e.g. hypo/hyperthyroidism, diabetes, renal failure.
- Seizure disorder or history of seizures (including febrile seizures).
- Abnormal and clinically significant results on the physical examination, vital signs, electrocardiogram, or laboratory tests at Screening Baseline.
- Any nasal obstruction, blockage, or symptoms of congestion at the time of dosing, that in the Investigator's opinion may interfere with administration of the study drug.
- Currently receiving lithium, antipsychotics, serotonergic drugs (excluding the permitted SSRIs for arm B), psychostimulants, or any other prohibited medication.
- Female patients who are pregnant or lactating, or of childbearing potential and not willing to use adequate forms of contraception.
- Male patients who are sexually active and not willing to using adequate forms of contraception.
