Phase
Condition
Borderline Personality Disorder
Mood Disorders
Williams Syndrome
Treatment
Placebo
BI 3031185
Clinical Study ID
Ages 18-45 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male, female, and non-binary participants, 18 to 45 years of age, both inclusively,at the time of consent
Meet current Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria as primary diagnosis as assessed by the Mini InternationalNeuropsychiatric Interview (MINI) at screening for borderline personality disorder (BPD) OR attention-deficit/hyperactivity disorder (ADHD)
Willingness to abstain from alcohol for 24 h, and all other drugs of abuse includingcannabis for 72 h prior to Visits 2 and 3 (Day -1). Willingness to abstain fromalcohol and cannabis for 72 h after investigational medicinal product (IMP)administration, as well as from all other recreational drugs for the duration of thetrial
Willingness to abstain from prescribed psychostimulants for 72 h prior to Visits 2and 3 (Day -1) and 24 h following IMP administration Further inclusion criteriaapply
Exclusion
Exclusion Criteria:
Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniformdisorder, bipolar I disorder, delusional disorder, autism spectrum disorder, orantisocial personality disorder as confirmed by the MINI
Any other psychiatric disorder that is not currently stable in symptoms andtreatment
Any substance use disorder within 3 months prior to randomisation (excluding mildalcohol, cannabis, tobacco, and caffeine use disorders); or moderate to severesubstance use disorder within the 6 months prior to randomisation (excluding tobaccoand caffeine)
Positive drug screen. Participants with positive cannabis drug tests can be includedif they do not meet criteria for moderate or severe cannabis use disorder and theinvestigator determines that use will not be an impediment to trial participation oraccurate data collection
Concomitant use of psychotropic medication except for the ones below. All otherpsychotropic medications must be washed out at least 30 days or 5 Half-life time (t1/2) (whichever is longer) before the start of Visit 2 (Day -1)
A single SSRI (selective serotonin re-uptake inhibitor) or SNRI (selectiveserotonin and norepinephrine re-uptake inhibitor) antidepressant that has beenstable in dose and frequency for >3 months prior to randomisation
A single second-generation antipsychotic at a low dose that has been stable indose and frequency for >3 months prior to randomisation (low dose = 1 thorazinedose equivalent or less, which translates to ≤2 mg/day for risperidone, 5mg/day for olanzapine, 75 mg/day for quetiapine, 60 mg/day for ziprasidone, and 7.5 mg/day for aripiprazole)
A single sleep medication given as a nightly scheduled medication (not pro renata) stable in agent and dose for >3 months prior to screening. Allowed sleepmedications include: non-benzodiazepine Z sleep medications, antihistamines,melatonin, trazodone, and doxepin
Participants taking psychostimulant medication prescribed as per label for ADHDmust stop medication 72 h prior to Visits 2 and 3 (Day -1) and may resume 24 hafter receiving the medication dose on the test day (i.e. 5 days total off ofprescribed psychostimulant for Visit 2 and 5 days off of prescribedpsychostimulant for Visit 3)
Any documented active or suspected malignancy or history of malignancy within 5years prior to screening, except appropriately treated basal cell carcinoma of theskin or in situ carcinoma of uterine cervix
A positive result for any active hepatitis
Previous randomisation in this trial Further exclusion criteria apply
Study Design
Connect with a study center
Rheinhessen-Fachklinik Alzey
Alzey, 55232
GermanySite Not Available
Charité Research Organisation GmbH
Berlin, 10117
GermanyActive - Recruiting
Charité Research Organisation GmbH
Berlin 2950159, 10117
GermanySite Not Available
Universitätsklinikum Bonn AöR
Bonn, 53127
GermanyActive - Recruiting
Universitätsklinikum Bonn AöR
Bonn 2946447, 53127
GermanySite Not Available
Technische Universität Dresden
Dresden, 01307
GermanySite Not Available
Universitätsklinikum Frankfurt
Frankfurt am Main, 60590
GermanyActive - Recruiting
Universitätsklinikum Frankfurt
Frankfurt am Main 2925533, 60590
GermanySite Not Available
Martin-Luther-Universität Halle-Wittenberg
Halle, 06112
GermanyActive - Recruiting
Martin-Luther-Universität Halle-Wittenberg
Halle 2911522, 06112
GermanySite Not Available
Universitätsklinikum Hamburg, Eppendorf
Hamburg, 20251
GermanySite Not Available
Medizinische Hochschule Hannover
Hanover, 30625
GermanySite Not Available
Universitätsklinikum Jena
Jena, 07743
GermanySite Not Available
Universitätsklinikum Jena
Jena 2895044, 07743
GermanySite Not Available
Zentrum Fuer Integrative Psychiatrie ZIP gGmbH Praevention-Therapie-Rehabilitation
Kiel, 24105
GermanySite Not Available
Universitätsklinikum Leipzig
Leipzig, 04103
GermanySite Not Available
Rheinhessen-Fachklinik Mainz
Mainz, 55122
GermanyActive - Recruiting
Rheinhessen-Fachklinik Mainz
Mainz 2874225, 55122
GermanySite Not Available
Zentralinstitut für seelische Gesundheit
Mannheim, 68159
GermanyActive - Recruiting
Zentralinstitut für seelische Gesundheit
Mannheim 2873891, 68159
GermanySite Not Available
Universitätsklinikum Tübingen
Tübingen, 72076
GermanyActive - Recruiting
Universitätsklinikum Tübingen
Tübingen 2820860, 72076
GermanySite Not Available

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