A Randomized, Placebo-Controlled, Double-Blind... — Clinical Trial Details

Detailed Description

Multicentre, randomized, triple-blind, parallel-group Phase II study comparing single IV infusions of R-ketamine (PCN-101) 30 mg, PCN-101 60 mg, and placebo in adults with treatment-resistant depression.

Design comprised screening, in-clinic treatment (double-blind infusion on Day 1) and follow-up visits on Days 8 and 15 to assess safety and depressive symptoms; primary purpose treatment.

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

18 - 35

Psychosis History

Inclusion Criteria

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 DSM-V, confirmed by MINI
Hamilton Depression Rating Scale total score > 20
Inadequate response to at least 2 antidepressants in the current episode given for >= 6 weeks
Stable oral antidepressant treatment without dose change for at least 30 days

Exclusion Criteria

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 likely to interfere with conduct or confound assessments
Primary DSM-V diagnosis of current MDD with psychotic features, panic disorder, OCD, PTSD, anorexia nervosa, or bulimia nervosa
Current or prior DSM-V diagnosis of a primary psychotic disorder, bipolar or related disorders, intellectual or autism spectrum disorder, or borderline personality disorder
Any significant disease or disorder that may put the subject at risk or influence study results
Uncontrolled hypertension (Screening SBP >160 mm Hg or DBP >90 mm Hg) or past hypertensive crisis
Abnormal ECG of clinical relevance at screening or baseline
Known history of, or positive serology for HIV, hepatitis B surface antigen, or hepatitis C infection
History of malignancy within 5 years prior to screening (with specified exceptions)
Homicidal ideation/intent or suicidal ideation with some intent to act within 1 month prior to screening, or history of suicidal behaviour within the past year
Major surgery within 4 weeks before screening or not fully recovered
Moderately impaired hepatic function (ALT or AST >2x ULN or total bilirubin >2x ULN)
Receipt of potent CYP2B6 or CYP3A inhibitors within 1 week or 5 half-lives prior to first dose
Disallowed antipsychotic within 30 days prior to screening (exceptions listed)
Changes in psychotropic medication type or dose within 30 days prior to screening
Treatment with MAOIs currently or within 30 days of screening
Oral contraception doses >30 µg ethinyl estradiol/day
Initiation of psychotherapy or acupuncture within 90 days of screening or planning to initiate during study
ECT, TMS, VNS, DBS, or other brain stimulation within 4 weeks prior to screening
Receipt of any IP within 30 days or 5 half-lives
History of substance abuse or dependence (except nicotine/caffeine) within 6 months prior to screening
History of nonresponse to ketamine, R-ketamine or S-ketamine, or receipt of >=8 doses in lifetime
Previous intolerance to ketamine, R-ketamine, or S-ketamine
History of abuse of ketamine, R-ketamine, S-ketamine, or phencyclidine
Avoid grapefruit, grapefruit juice, or Seville orange products for 72 hours before IP administration and throughout study
Presence of clinically relevant long-term COVID-19 symptoms or current signs/symptoms of COVID-19
COVID-19 vaccination allowed if >=30 days before study drug administration; vaccination not allowed during study

Company

Product

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

PCN-101 30 mg

Interventions

PCN-101 60 mg

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators