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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05414422
Recruitment Status : Recruiting
First Posted : June 10, 2022
Last Update Posted : August 5, 2022
Sponsor:
Collaborators:
Precision For Medicine
IQVIA Biotech
Information provided by (Responsible Party):
Perception Neuroscience

Tracking Information
First Submitted Date  ICMJE May 27, 2022
First Posted Date  ICMJE June 10, 2022
Last Update Posted Date August 5, 2022
Actual Study Start Date  ICMJE February 1, 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2022)
Montgomery Asberg Depression Rating Scale (MADRS) 24 Hours [ Time Frame: 24 hours ]
Change from baseline to 24 hours after the start of infusion in the Montgomery Asberg Depression Rating Scale (MADRS)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2022)
  • Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement [ Time Frame: 2 hours, 4 hours, 24 hours, 7 days and 14 days ]
    Proportion of subjects with >= 50% improvement in MADRS total score from predose
  • Montgomery Asberg Depression Rating Scale (MADRS) <= 10 [ Time Frame: 24 hours, 7 days and 14 days ]
    Proportion of subjects with remission (MADRS total score <= 10)
  • Hamilton Depression Rating Scale (HAM-D) Change from Baseline [ Time Frame: 7 days and 14 days ]
    Change from Baseline in HAM-D
  • Generalized Anxiety Disorder (GAD-7) Change from Baseline [ Time Frame: 24 hours, 7 days and 14 days ]
    Change from Baseline in GAD-7
  • Clinical Global Impression - Severity (CGI-S) Change from Baseline [ Time Frame: 24 hours, 7 days and 14 days ]
    Change from Baseline in CGI-S
  • Clinical Global Impression - Improvement (CGI-I) Change from Predose [ Time Frame: 24 hours, 7 days and 14 days ]
    Change from predose CGI-S
  • Quick Inventory of Depressive Symptomatology (QIDS-SR-16) Change from Baseline [ Time Frame: 24 hours, 7 days and 14 days ]
    Change from Baseline in QIDS-SR-16
  • European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change from Baseline [ Time Frame: 24 hours, 7 days and 14 days ]
    Change from Baseline in EQ-5D-3L
  • Treatment-emergent adverse events summarized by treatment group, system organ class and preferred term [ Time Frame: 14 days ]
    The number of participants in each treatment group with treatment-emergent adverse events categorized using MedDRA v23.0 or higher
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD
Official Title  ICMJE A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of Intravenous PCN-101 in Treatment Resistant Depression
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Treatment Resistant Depression
Intervention  ICMJE
  • Drug: PCN-101
    Concentrate for solution for infusion
    Other Name: R-ketamine
  • Drug: Placebo
    Concentrate for solution for infusion
Study Arms  ICMJE
  • Experimental: PCN-101 30 mg
    PCN-101 30 mg
    Intervention: Drug: PCN-101
  • Experimental: PCN-101 60 mg
    PCN-101 60 mg
    Intervention: Drug: PCN-101
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 8, 2022)
93
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Group +1 646 905 3973 ext 2 clinicaltrials@perceptionneuroscience.com
Listed Location Countries  ICMJE Germany,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05414422
Other Study ID Numbers  ICMJE PCN-101-21
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Perception Neuroscience
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Perception Neuroscience
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Precision For Medicine
  • IQVIA Biotech
Investigators  ICMJE
Study Director: Chief Medical Officer Perception Neuroscience
PRS Account Perception Neuroscience
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP