Clinical trial to determine the efficacy and safety of AP707 in the treatment of Borderline Personality Disorder

Who can take part

• Signed and dated study informed consent forms, demonstrating willingness to comply with trial instructions
• Zanarini rating scale for borderline personality disorder (ZAN-BPD, 0-36) of ≥ 10 at screening
• Female and male participants aged 18 years or older at the time of informed consent signa-ture
• Participants with main diagnosis of borderline personality disorder (BPD) per Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
• BPD was confirmed by structured interview for DSM-5 Personality Disorder (SCID-5-PD) at screening visit
• Stable dosage of psychiatric medication (e.g., antidepressants, mood stabilizers, antipsychotics) for at least 28 days prior to screening or no medication intake. This does not apply to pro re nata medication
• Participants commitment to use effective contraception methods (<1% failure rate) from screening to end of follow-up. This does not apply for persons of abstinence from sexual inter-course or non-childbearing potential (i.e. post-menopausal, surgically sterile). An effective contraception usually includes the use of a barrier method with another contraception method simultaneously
• Good command of German language, to fully understand the questionnaires
• Participants must have a smartphone on which the EDC application can be installed

Who cannot take part

• Initiation or change in any type or frequency of psychotherapy within 3 months prior to screening. Exceptions: a) Participants with ongoing, stable outpatient psychotherapy > 3 months prior to screening (and intend to maintain the same frequency during the trial) could qualify as per clinical judgement of the investigator. b) Participants who completed inpatient therapy at least 14 days prior to the screening visit could qualify as per clinical judgement of the investigator
• The intake of at least one of the following medications before and during the study: Clozapine, Carbamazepine, Valproic acid, St. John’s wort, grapefruit juice, constant benzodiazepine use. Exception: The therapy had been discontinued at least 21 days prior to screening and the discontinuation must have been independent of participation in the study
• Known use of cannabis products within the last 28 days before screening or during the study
• Participation in another clinical trial within the last four weeks prior to screening or the administration of another IMP within 5 half-lives before screening
• Medical history of hypersensitivity or intolerance to the IMP or its ingredients or to ingredients of similar chemical structure
• Clinical diagnosis of paranoid, schizoid, schizotypal and acute severe substance use disorder according to DSM-5
• Lifetime diagnosis for schizophrenia spectrum and other psychotic disorders, schizoaffective disorder, schizophreniform disorder, bipolar disorder, or delusional disorder as confirmed by the SCID-5-PD interview at the screening visit
• Any psychiatric condition that, in the investigator's opinion, would prevent the participant from adhering to the protocol or completing the clinical trial per protocol
• Known severe cardiovascular disease such as cardiac insufficiency (New York Heart Association Classification (NYHA) Class III-IV), acute myocardial infarction, any form of cardiomyopathy (not to be counted as exclusion criteria: hypertension, adjusted cardiac arrhythmias, recovered from infectious heart diseases)
• An ECG QTc limit value of more than 450 milliseconds in men and an ECG QTc limit value of more than 470 milliseconds in women
• Known liver disease or alanine aminotransferase (ALT, GPT) or aspartate aminotransferase (AST, GOT) or alkaline phosphatase (AP, ALP) level ≥ 2.5 x upper limit of normal (ULN) or bilirubin ≥ 1.5 x ULN at screening
• Known kidney disease or serum creatinine ≥ 1.5 x ULN or estimated glomerular filtration rate < 60 mL/min at screening
• Acute suicidality according to clinical judgement (based on psychopathological findings and C-SSRS interview)
• Any clinically significant finding of the physical examination that would jeopardize the participant´s safety during the trial
• Participant is study investigator or personnel of a trial site, the sponsor or involved service providers and/or their immediate families (partner, spouse, parent, child, or sibling, whether biological or legally adopted)
• Known intolerance to cannabinoids or cannabis products
• Females who are currently pregnant or lactating or intend to become pregnant during the trial
• Participant is considered to belong to a vulnerable population (e.g. not capable of giving consent independently, imprisoned, other)