2024-510873-11-00招募中2 期
A phase II, double-blinded, placebo-controlled, clinical trial to determine the efficacy and safety of AP707 in the treatment of Borderline Personality Disorder.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 154
- 试验地点
- 13
- 主要终点
- (i) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in ZAN-BPD total score at EoT;
研究概览
简要总结
The primary objective of this trial is to show the efficacy of AP707 in Borderline Personality Disorder participants compared to placebo regarding the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) and the Borderline Symptom Scale for Borderline Personality Disorder (BSL-23).
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •Medical history of hypersensitivity or intolerance to the IMP or its ingredients or to ingredients of similar chemical structure;
- •Acute suicidality according to clinical judgement (based on psychopathological findings and C-SSRS interview);
- •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.
- •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;
- •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;
- •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;
- •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);
- •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 intolerance to cannabinoids or cannabis products;
- •Known use of cannabis products within the last 28 days before screening or during the study;
- •Females who are currently pregnant or lactating or intend to become pregnant during the trial;
- •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;
- •Participant is considered to belong to a vulnerable population (e.g. not capable of giving consent independently, imprisoned, other);
- •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);
- •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;
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
AP707
Test
干预措施: AP707 (Drug)
结局指标
主要结局
(i) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in ZAN-BPD total score at EoT;
(i) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in ZAN-BPD total score at EoT;
(ii) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in BSL-23 total score at EoT.
(ii) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in BSL-23 total score at EoT.
次要结局
- 1. a) Proportion of ZAN-BPD responders (i.e., participants with ≥30% ZAN-BPD total score reduction at EoT compared to baseline) (verum compared to pla-cebo)
- 1. b) Proportion of ZAN-BPD responders (i.e., participants with ≥50% ZAN-BPD total score reduction at EoT compared to baseline) (verum compared to pla-cebo)
- 1. c) Time to first response of participants who experienced ≥30% ZAN-BPD total score reduction at EoT compared to baseline (verum com-pared to placebo)
- 6. Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in DERS-36 total score at EoT
- 1. d) Time to first response of participants who experienced ≥50% ZAN-BPD total score reduction at EoT compared to baseline (verum com-pared to placebo)
- 2. a) Proportion of BSL-23 responders (i.e., participants with ≥30% BSL-23 total score reduction at EoT compared to baseline) (verum compared to pla-cebo)
- 2. b) Proportion of BSL-23 responders (i.e., participants with ≥50% BSL-23 total score reduction at EoT compared to baseline) (verum compared to placebo)
- 2. c) Time to first response of participants who experienced ≥30% BSL-23 total score reduction at EoT compared to baseline (verum compared to pla-cebo)
- 2. d) Time to first response of participants who experienced ≥50% BSL-23 total score reduction at EoT compared to baseline (verum compared to placebo)
- 3. Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in CGI-S score at EoT (additionally: at V2, V3, …, V9)
- 4. Proportion of participants per PGI-C score at EoT
- 5. a) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in STAXI-2 (Trait-Anger) t-value at EoT
- 5. b) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in STAXI-2 (Anger Expression-Out) t-value at EoT
- 5. c) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in STAXI-2 (Anger Expression-In) t-value at EoT
- 5. d) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in STAXI-2 (Anger Control) t-value at EoT
- 7. a) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in Patient Health Questionnaire (PHQ-9) total score at EoT
- 7. b) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in Montgomery-Åsberg Depression Rat-ing Scale (MADRS) total score at EoT
- 8. a) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in STAI (State-Anxiety) score at EoT
- 8. b) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in STAI (Trait-Anxiety) score at EoT
- 9. a) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in Barratt Impulsiveness Scale 15 (BIS-15) total score at EoT
- 9. b) Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in impulsive sector score of ZAN-BPD at EoT
- 10. Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in interpersonal sector score of ZAN-BPD at EoT
- 11. Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in cognitive sector score of ZAN-BPD at EoT
- 12. Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in affective sector score of ZAN-BPD at EoT
- 13. Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in NRS-Pain score at EoT
- 14. Number of participants with rescue medication over the course of the clinical trial and within periods: until Visit ≤ V2 (1 week), ≤ V3 (2 weeks), ≤ V4 (3 weeks), ≤ V5 (5 weeks), ≤ V6 (7 weeks), ≤ V7 (9 weeks), ≤ V8 (11 weeks), ≤ V9 (13 weeks), ≤ EoT (15 weeks), ≤ FU (18 weeks)
研究者
Medical Affairs
Scientific
Apurano Pharmaceuticals GmbH
研究点 (13)
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