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

NCT05414422 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PCN-101-21
• Study Type: interventional
• Target: 102
• Locations: 3 countries
• Sites: 21

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

Keywords

PCN-101; R-ketamine

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Depression Rating Scale (MADRS) 24 Hours

  Change from baseline to 24 hours after the start of infusion in the Montgomery Asberg Depression Rating Scale (MADRS). The overall score ranges from 0 to 60. Higher scores indicates more severe depression.

  24 hours

Secondary Outcomes (9)

• Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement

  2 hours, 4 hours, 24 hours, 7 days and 14 days

• Montgomery Asberg Depression Rating Scale (MADRS) <= 10

  24 hours, 7 days and 14 days

• Hamilton Depression Rating Scale (HAM-D) Change From Baseline

  7 days and 14 days

• Generalized Anxiety Disorder (GAD-7) Change From Baseline

  24 hours, 7 days and 14 days

• Clinical Global Impression - Severity (CGI-S) Change From Baseline

  24 hours, 7 days and 14 days

Study Arms (3)

PCN-101 30 mg

EXPERIMENTAL

PCN-101 30 mg

Drug: PCN-101

PCN-101 60 mg

EXPERIMENTAL

PCN-101 60 mg

Drug: PCN-101

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PCN-101 DRUG

Concentrate for solution for infusion

Also known as: R-ketamine

PCN-101 30 mg; PCN-101 60 mg

Placebo DRUG

Concentrate for solution for infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Perception Neuroscience: lead
• Precision For Medicine: collaborator
• IQVIA Biotech: collaborator

Study Sites (21)

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

CNS Network

Garden Grove, California, 92845, United States

Location

Kadima Neuropsychiatry Institute

La Jolla, California, 92037, United States

Location

Synergy San Diego

Lemon Grove, California, 91945, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

Premier Clinical Research Institute Inc.

Miami, Florida, 33122, United States

Location

Psych Atlanta

Marietta, Georgia, 30060, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Neuro-Behavioral Clinical Research

North Canton, Ohio, 44720, United States

Location

Insite Clinical Research LLC; Inpatient facility name: Serenity

DeSoto, Texas, 75115, United States

Location

Pillar Clinical Research, LLC

Richardson, Texas, 75080, United States

Location

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt, 60528, Germany

Location

Pharmakologisches Studienzentrum Chemnitz GmbH

Mittweida, 09648, Germany

Location

Somni bene GmbH

Schwerin, 19053, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, 97080, Germany

Location

Indywidualna Specjalistyczna Praktyka Lekarska

Gdansk, 80-438, Poland

Location

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, 80-546, Poland

Location

Wojewodzki Szpital Dla Nerwowo i Psychicznie Chorych

Gmina Świecie, 86-100, Poland

Location

Prywatny Gabinet Lekarski Jaroslaw Strzelec

Tuszyn, 95-080, Poland

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Clinical Trials Group
• Organization: Perception Neuroscience

clinicaltrials@perceptionneuroscience.com

+49 (0) 89 2153 9035

Study Officials

• Chief Medical Officer

  Perception Neuroscience

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 10, 2022
• Study Start: February 1, 2022
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: June 4, 2024
• Results First Posted: June 4, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); PL (4); US (13)