A phase II, double-blinded, placebo-controlled, clinical trial to determine the efficacy and safety of AP707 in the treatment of Borderline Personality Disorder.

Condition studied

Borderline personality disorder

Investigational medicinal product(s)

Eligibility

Primary endpoint

(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.

Endpoint detail

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), 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, 6. Baseline adjusted difference (verum compared to placebo) in (mean) change from baseline in DERS-36 total score 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)