Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
LMU Klinikum
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
• Written informed consent obtained from the participant prior to performing any protocol-related procedures, including screening evaluations
* A DSM-V diagnosis of schizophrenia or schizophrenia-spectrum disorder according to MINI interview
* Age between 18 and 65 years EudraCT Number: 2022-000054-28 Confidential OligoTreat Study Protocol Version 2.0 06.09.2023 9 of 62
* Total Positive and Negative Syndrome Scale (PANSS) score ≤ 75 at V0
* Stable antipsychotic treatment dose for at least one week prior to inclusion
* Stable CNS-active treatment substance and dose (e.g. antidepressants and mood stabilizers) for at least one week prior to inclusion
* Female participants with reproductive potential must have a negative beta- HCG serum pregnancy test as part of the screening visit
* Female participants with reproductive potential must have a negative serum pregnancy test within seven days prior to randomization
* Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country at screening
You may not be if
Patients who are unable to give informed consent
* Coercive treatment at the time of study inclusion
* Treatment-naïve schizophrenia defined as cumulative treatment with an antipsychotic agent lifetime for \<30 days
* Insufficient understanding of the German language
* Patients with primary active (moderate or severe) substance use disorder (other than nicotine) according to MINI interview (DSM-V): patients fulfilling early (\>3 months) or sustained (\>12 months) remission criteria and/or with low severity of substance use disorder according to MINI are eligible for the study
* Known clinically relevant CNS disorder(s), such as epilepsy or history of seizures
* Concomitant use of any other putative remyelinating therapy as determined by investigator
* Co-occurrent unstable somatic condition
* Known porphyria
* Known narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy with urinary retention and bladder neck obstruction Current treatment with agents with strong anticholinergic properties, such as MAO-inhibitors, opioid antagonists, clozapine at the time of study inclusion
* Known intolerance, allergy/contraindications to one of the study drugs or any of the excipients or other agents with similar chemical properties as the study drugs (such as other arylalkylamine antihistamines)
* Clinically relevant liver and/or renal impairment (serum creatinine \>1.5mg/dl or eGFR\<30 ml/min/1.73 m2 at screening, AST or ALT \> 2-times the upper limit of normal at screening)
* Current treatment with macrolide-antibiotics (such as erythromycin, clarithromycine) or azole-type antimycotics
* Clinically relevant cardiac comorbidities (i.e. Long QT-syndrome)
* Current hypokalaemia and/or clinically relevant hyponatraemia at screening
* Concurrent enrolment in another clinical trial where the participant is receiving an IMP or participation in another clinical trial with IMP during the last 30 days before inclusion or 7 half-lives of previously used IMP, whichever is longer.
* For the optional MRI assessments: potential MRI contraindication(s)
