A randomized, placebo-controlled, double-blind study to assess the safety and efficacy of intravenous PCN-101 in treatment-resistant depression

Perception Neuroscience, Inc0 sites93 target enrollmentAugust 2, 2021

ConditionsTreatment-resistant depression MedDRA version: 20.0Level: PTClassification code 10012378Term: DepressionSystem Organ Class: 10037175 - Psychiatric disorders Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Treatment-resistant depression
Sponsor: Perception Neuroscience, Inc
Enrollment: 93
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 2, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Perception Neuroscience, Inc

Eligibility Criteria

Inclusion Criteria

•Subjects are eligible to be included in the study only if all of the following criteria apply:
•1\. Be capable of giving and give signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
•2\. Be male or female 18 to 65 years of age inclusive at the time of signing the Informed Consent Form (ICF).
•3\. Weigh \= 50 kg and \= 100 kg and have a body mass index (BMI) \= 18 and \= 30\.
•4\. Have a diagnosis of recurrent major depressive disorder (MDD) without psychotic features per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM\-V), confirmed by the Mini\-International Neuropsychiatric Interview (MINI).
•5\. Have a Hamilton Depression Rating Scale (HAM\-D) total score \> 18 at screening and baseline (Day \-1\).
•6\. Have an inadequate response to at least 2 antidepressants in the current episode of depression that were each given for \> 6 weeks at an adequate dose as defined by the Massachusetts General Hospital Antidepressant Response Questionnaire (MGH\-ATRQ).
•7\. Must be on stable oral antidepressant treatment for at least 30 days before screening.
•8\. Due to the potential for adverse fetal effects, a male subject must be medically confirmed sterile for at least 6 months prior to screening or agree to use highly effective contraception during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period. If a male with a heterosexual partner who is a woman of childbearing potential (WOCBP) is included, his female partner also needs to use highly effective birth control measures.
•9\. Due to the potential for adverse fetal effects, a female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

Exclusion Criteria

•1\. History of, or current signs and symptoms of, diseases or conditions that would make participation not be in the best interest (eg, compromise the well\-being) of the subject or that could prevent, limit, or confound the protocol\-specified assessments.
•2\. Has a history of seizures.
•3\. Has a current or prior DSM\-V diagnosis of a psychotic disorder or MDD with psychotic features, bipolar or related disorders (confirmed by the MINI), obsessive compulsive disorder (current only), intellectual or autism spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder.
•4\. Has any significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) 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.
•5\. Has hypertension (systolic blood pressure \[SBP] \> 140 mm Hg or diastolic blood pressure \[DBP]\> 90 mm Hg) or any past history of hypertensive crisis. An abnormal blood pressure value at screening may be repeated once after 5 minutes of relaxation to determine the subject’s eligibility.
•6\. Has an abnormal ECG of clinical relevance at screening or baseline including, but not limited to, the following:
•QTcF interval \> 450 msec.
•Evidence of 2nd and 3rd degree atrioventricular (AV) block, or 1st degree AV block with PR interval \> 200 msec, left bundle branch block (LBBB) or right bundle branch block (RBBB) at screening or baseline; incomplete RBBB will not permitted.
•Has a history of risk factors including hypokalemia, family history of Long QT Syndrome, or prior use of medications that prolong the QT/QTc interval.
•7\. Has known history of human immunodeficiency virus (HIV); has a positive hepatitis B surface antigen, positive hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without a history of hepatitis B are allowed to enroll.