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

NCT ID: NCT05414422

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-11-10

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.

Conditions

Treatment Resistant Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

PCN-101 30 mg

PCN-101 30 mg

Group Type: EXPERIMENTAL

PCN-101

Intervention Type: DRUG

Concentrate for solution for infusion

PCN-101 60 mg

PCN-101 60 mg

Group Type: EXPERIMENTAL

PCN-101

Intervention Type: DRUG

Concentrate for solution for infusion

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Concentrate for solution for infusion

Interventions

PCN-101

Concentrate for solution for infusion

Intervention Type: DRUG

Placebo

Concentrate for solution for infusion

Intervention Type: DRUG

Other Intervention Names

R-ketamine

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Precision For Medicine

INDUSTRY

Sponsor Role: collaborator

IQVIA Biotech

INDUSTRY

Sponsor Role: collaborator

Perception Neuroscience

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_DIRECTOR

Perception Neuroscience

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

Countries

United States; Germany; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PCN-101-21

Identifier Type: -

Identifier Source: org_study_id