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A study to evaluate the effectiveness and safety of AP707 in patients with borderline personality disorder.

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Borderline Personality Disorder, a mental health condition that can affect how a person manages emotions and relates to others. The purpose of the study is to evaluate how well the investigational drug AP707, which contains the substance adezunap, works and how safe it is for people with this condition. This medication is administered as an oromucosal spray, which is a liquid medicine applied directly to the inside of the mouth.

During the trial, participants are assigned to receive either AP707 or a placebo. The study is double-blind, meaning that neither the participants nor the researchers know which treatment is being given until the end of the study. This is done to ensure that the results are not influenced by expectations. Over a set period, the effectiveness of the treatment will be compared against the placebo to see if there are improvements in symptoms associated with the disorder.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the trial

    The treatment phase begins with the administration of either the study medication, ap707, or a placebo, which is an inactive substance that contains no medicine. because this is a double-blind study, it is not known which substance is being received.

    The ap707 medication is an oromucosal spray, which is a liquid applied directly to the lining of the mouth, and is administered at a dose of 16.5 mg.

  2. Step 2

    Monitoring and assessment

    During the trial, various scales and assessments are used to measure changes in symptoms related to borderline personality disorder. these assessments evaluate areas such as mood, anger, impulsivity, anxiety, and interpersonal relationships.

    The end of trial occurs after a period of 15 weeks of treatment, during which the effectiveness and safety of the medication are monitored through these regular assessments.

Who can join the trial?

9 criteria

  • You must sign and date a consent form, which is a document that explains the study and shows you agree to participate according to the instructions.
  • You must have a score of 10 or higher on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD), which is a tool used by doctors to measure the severity of symptoms.
  • You must be 18 years of age or older at the time you sign the consent form.
  • Your main diagnosis must be Borderline Personality Disorder (BPD), as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), which is the standard guidebook used by healthcare professionals to identify mental health conditions.
  • Your diagnosis must be confirmed using a Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD), which is a specific, organized conversation with a professional to verify a diagnosis.
  • You must have been taking a stable dose of psychiatric medications—such as antidepressants (medicine for mood), mood stabilizers (medicine to balance emotions), or antipsychotics (medicine for thought patterns)—for at least 28 days before the study begins, or you must not be taking any such medication at all. This rule does not apply to pro re nata medication, which refers to medicine taken only when needed for specific symptoms.
  • You must agree to use highly effective contraception, which is a method used to prevent pregnancy, with a failure rate of less than 1%. This requirement does not apply if you are abstinent, or if you are unable to become pregnant due to menopause or surgery.
  • You must be able to speak and understand German well enough to complete all study forms and questions.
  • You must own a smartphone that is capable of running the study's specific mobile application.

Who cannot join the trial?

17 criteria

  • You cannot participate if you have a history of hypersensitivity or intolerance, which means you have had an allergic reaction or a bad physical reaction to the study medication or its ingredients.
  • You cannot participate if you are experiencing acute suicidality, which refers to immediate and serious thoughts or actions regarding self-harm, as determined by medical professionals.
  • You cannot participate if you have started or changed any type of psychotherapy (talk therapy) in the last 3 months, unless your therapy has been stable for more than 3 months or you finished hospital-based therapy at least 14 days ago.
  • You cannot participate if you have been diagnosed with paranoid, schizoid, or schizotypal personality disorders, or an acute severe substance use disorder (a sudden and serious addiction to drugs or alcohol).
  • You cannot participate if you have ever been diagnosed with schizophrenia spectrum or psychotic disorders (conditions where people lose touch with reality), schizoaffective disorder, schizophreniform disorder, bipolar disorder (extreme mood swings), or delusional disorder.
  • You cannot participate if you are currently taking, or have recently taken, certain medications like Clozapine, Carbamazepine, Valproic acid, or benzodiazepines (medications used for anxiety or sleep), or if you consume St. John’s wort or grapefruit juice. These must have been stopped at least 21 days ago.
  • You cannot participate if a doctor believes any of your mental health conditions would make it difficult for you to follow the study rules or finish the trial.
  • You cannot participate if a physical exam shows any health issues that could make participating in the study unsafe for you.
  • You cannot participate if you or your immediate family members work for the company sponsoring the study or work at the medical site where the study is happening.
  • You cannot participate if your ECG QTc (a measurement of the heart's electrical timing) is higher than 450 milliseconds for men or 470 milliseconds for women.
  • You cannot participate if you cannot tolerate cannabinoids or cannabis (marijuana products) or if you have used them within the last 28 days.
  • You cannot participate if you are pregnant, breastfeeding, or plan to become pregnant during the study.
  • You cannot participate if you have taken another study medication recently or participated in a different clinical trial within the last four weeks.
  • You cannot participate if you are considered part of a vulnerable population, such as being unable to give legal consent or being currently imprisoned.
  • You cannot participate if you have severe cardiovascular disease (heart problems), such as cardiac insufficiency (the heart cannot pump enough blood), a recent myocardial infarction (heart attack), or cardiomyopathy (disease of the heart muscle).
  • You cannot participate if you have liver disease or if certain liver enzymes in your blood, such as ALT, AST, AP, or bilirubin, are significantly higher than normal levels.
  • You cannot participate if you have kidney disease or if your blood tests show high levels of creatinine or a low estimated glomerular filtration rate (a measure of how well your kidneys filter blood).
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Investigated drugs

AP707 is a medication administered as a spray or liquid held in the mouth, being tested to see if it can help improve symptoms in people living with Borderline Personality Disorder.

What is already known about the treatment

Adezunap - This medication is administered as an oral spray or suspension applied directly to the inside of the mouth. It is currently being investigated in clinical research and is not yet a standard treatment in medical practice. This substance is used to help manage symptoms of borderline personality disorder by working at a molecular level to influence how brain chemicals communicate. It is classified as a psychiatric medication designed to stabilize mood and emotional responses.

Investigated diseases

Borderline personality disorder - This condition is a mental health disorder characterized by significant instability in emotions, self-image, and relationships. People with this disorder often experience intense mood swings and difficulty controlling anger. It frequently involves patterns of impulsive behavior and an unstable sense of identity. Social interactions may be marked by intense and unpredictable emotional responses. The symptoms can fluctuate in intensity over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510873-11-00Protocol codeIlluminateEstimated enrolment154 patientsSponsorApurano Pharmaceuticals GmbH

sourced from the EU Clinical Trials Register and site verification

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