A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD

  • STATUS
    Recruiting
  • days left to enroll
    37
  • participants needed
    93
  • sponsor
    Perception Neuroscience
Updated on 4 October 2022

Summary

This is a double-blind, randomized, placebo-controlled, multicenter study comprised of 3 phases:screening (up to 2 weeks [Day -15 to Day -2]), In-Clinic Treatment (Day -1 to Day 2; including double-blind treatment [Day 1]), and post-treatment follow-up (7 and 14 days after infusion on Days 8 and 15, respectively). A total of 93 adult subjects with TRD will be randomly allocated in equal cohorts of 31 subjects/arm to the 3 arms of the study in a blinded manner.

Details
Condition Treatment Resistant Depression
Treatment Placebo, PCN-101
Clinical Study IdentifierNCT05414422
SponsorPerception Neuroscience
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Capable of giving and give signed informed consent
Weigh >= 50 kg and have a body mass index >= 18 and <= 35
Diagnosis of recurrent major depressive disorder (MDD) without psychotic features per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), confirmed by Mini-International Neuropsychiatric Interview
Hamilton Depression Rating Scale total score > 20
Inadequate response to at least 2 antidepressants in the current episode of depression that were given for >= 6 weeks
Stable oral antidepressant treatment without dose change for at least 30 days

Exclusion Criteria

History of, or current signs and symptoms of diseases or conditions that would make participation not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments
History of moderate or severe head trauma or other neurological disorders, neurodegenerative disorder or systemic medical diseases that are in the opinion of the Investigator likely to interfere with the conduct of the study or confound the study assessments
Has a primary DSM-V diagnosis of current (active) MDD with psychotic features, panic disorder, obsessive compulsive disorder, posttraumatic stress disorder, anorexia nervosa, or bulimia nervosa
Has a current of prior DSM-V diagnosis of a primary psychotic disorder, bipolar or related disorders, intellectual or autism spectrum disorder, or borderline personality disorder
Has any significant disease or disorder that in the opinion of the investigator, may either put the subject at risk because of participation in the study, influence the results of the study, or affect the subject's ability to participate in the study
Has uncontrolled hypertension, despite medication, at Screening systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg or any past history of hypertensive crisis
Has an abnormal ECG of clinical relevance at screening or baseline
Has known history of, or positive serology for human immunodeficiency virus, hepatitis B surface antigen, hepatitis C infection
Has a history of malignancy within the 5 years prior to screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy that in the opinion of the investigator, with concurrence with the Sponsor's Medical Monitor, is considered to have minimal risk of recurrence)
Has homicidal ideation/intent per the Investigator's clinical judgment, or has suicidal ideation with some intent to act within 1 month prior to the start of screening per the Investigator's clinical judgement or based on the C-SSRS, or a history of suicidal behavior within the past year prior to the start of the screening/prospective observational phase
Has had major surgery within the 4 weeks before screening, or will not have fully recovered from surgery or planned surgery during the time the subject is expected to participate in the study
Has moderately impaired hepatic function at screening, defined as serum alanine aminotransferase or aspartate aminotransferase > 2 × upper limit of normal or total bilirubin > 2 × upper limit of normal
Has received any disallowed therapies as follows
Receipt of a known potent inhibitor of hepatic cytochrome P450 (CYP) 2B6, or CYP3A, activity within 1 week or within a period 5 times the drug's half-life, whichever is longer, before the first administration of study drug on Day 1
Treatment with a disallowed antipsychotic within the past 30 days prior to screening, except subjects who are on stable doses of quetiapine, aripiprazole, brexpiprazole, or olanzapine prescribed as adjunct treatment for depression (without psychosis) may be included in the study
Any changes in psychotropic medication type or dose within the past 30 days prior to screening
Treatment with monoamine oxidase inhibitors currently or within the past 30 days of screening
Doses of oral contraception should not contain more than 30 micrograms of ethinyl estradiol per day
Has initiated psychotherapy or acupuncture acupuncture within the past 90 days of screening. Patients planning to initiate individual or group therapy during the study are also not eligible
Has received electroconvulsive therapy, transcranial magnetic stimulation, vagal nerve stimulation, deep brain stimulation, or other brain stimulation treatment within the past 4 weeks or currently used as either an acute or maintenance treatment of depression
Has received any IP within 30 days or 5 half-lives
Has a history of substance abuse (drug or alcohol) or dependence (except nicotine or caffeine) within the previous 6 months prior to the screening visit
Has a history of previous nonresponse to ketamine, R-ketamine or S-ketamine, or has received 8 or more doses of ketamine, R-ketamine or S-ketamine in their lifetime
Has a previous history of intolerance to ketamine, R-ketamine, or S-ketamine
History of abuse of ketamine, R-ketamine, S-ketamine, or phencyclidine
Subjects should not consume grapefruit, grapefruit juice, or Seville orange related products for 72 hours before IP administration and throughout the study
Has the presence of clinically relevant long-term COVID-19 symptoms. Has current signs or symptoms of COVID-19
COVID-19 vaccination is allowed as long as the doses are administered ≥ 30 days before study drug administration; vaccination is not allowed during the course of the study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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