Study to assess the safety and efficacy of PCN-101 in treatment-resistant depressio
- Conditions
- Treatment-resistant depressionMedDRA version: 20.0Level: PTClassification code 10012378Term: DepressionSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2020-005457-25-IT
- Lead Sponsor
- Perception Neuroscience
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 93
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:
• Not of childbearing potential (see Appendix 5).
• A WOCBP who agrees to follow the contraceptive guidance (see Appendix 5) on highly effective birth control measures during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating eggs during this period.
10. Be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. If there are abnormalities, the subject may be included only if the Investigator
judges the abnormalities not to be clinically important. This determination must be recorded in the subject's source documents and initialed by the Investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 93
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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:
• 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.
8. 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).
9. Has homicidal ideation/intent per the Investigator's clinical judgment; or has suicidal ideation with some intent to act within 6 months prior to the start of the screening per the Investigator's clinical judgment or based on the C-SSRS, corresponding to a response of Yes on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent); or a history of suicidal behavior within the past year prior to the start of the screening/prospective observational phase.
10. Has had major surgery (eg, requiring general or local anesthesia) 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.
11. Has moderately impaired hepatic function at screening, defined as serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × upper limit of normal (
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method