Clinical TrialTreatment-Resistant Depression (TRD)KetamineKetaminePlaceboCompleted

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

This double-blind, randomized, placebo-controlled trial (n=93) aimed to assess the safety and efficacy of IV ketamine (PCN-101) in treating Treatment-Resistant Depression (TRD).

Target Enrollment
102 participants
Study Type
Phase II interventional
Design
Randomized, triple Blind

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.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

PCN-101 30 mg

experimental

IV R-ketamine (PCN-101) single infusion, 30 mg.

Interventions

  • Ketamine30 mg
    via IV• single dose• 1 doses total

    R-ketamine (PCN-101) 30 mg IV infusion

PCN-101 60 mg

experimental

IV R-ketamine (PCN-101) single infusion, 60 mg.

Interventions

  • Ketamine60 mg
    via IV• single dose• 1 doses total

    R-ketamine (PCN-101) 60 mg IV infusion

Placebo

inactive

Placebo infusion comparator.

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    Placebo concentrate for solution for infusion

Participants

Ages
18 – 65
Sexes
Male & Female

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

Study Details

Locations

Preferred Research Partners — Little Rock, Arkansas, United States
CNS Network — Garden Grove, California, United States
Kadima Neuropsychiatry Institute — La Jolla, California, United States
Synergy San Diego — Lemon Grove, California, United States
NRC Research Institute — Orange, California, United States
Premier Clinical Research Institute Inc. — Miami, Florida, United States
Psych Atlanta — Marietta, Georgia, United States
Hassman Research Institute — Berlin, New Jersey, United States
Princeton Medical Institute — Princeton, New Jersey, United States
Midwest Clinical Research Center — Dayton, Ohio, United States
Neuro-Behavioral Clinical Research — North Canton, Ohio, United States
Insite Clinical Research LLC; Inpatient facility name: Serenity — DeSoto, Texas, United States
Pillar Clinical Research, LLC — Richardson, Texas, United States
Klinikum der Johann Wolfgang Goethe-Universitaet — Frankfurt, Germany
Pharmakologisches Studienzentrum Chemnitz GmbH — Mittweida, Germany
Somni bene GmbH — Schwerin, Germany
Universitaetsklinikum Wuerzburg — Würzburg, Germany
Indywidualna Specjalistyczna Praktyka Lekarska — Gdansk, Poland
Centrum Badan Klinicznych PI-House sp. z o.o. — Gdansk, Poland
Wojewodzki Szpital Dla Nerwowo i Psychicznie Chorych — Gmina Świecie, Poland
Prywatny Gabinet Lekarski Jaroslaw Strzelec — Tuszyn, Poland

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