Schizophrenia MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Clemastinfumarat
Pharmaceutical Form: Tablet
INN or Proposed INN: Clemastine fumarate
CAS Number: 14976-57-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
Klinikum der Universität München
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written informed consent obtained from the participant prior to performing any protocol-related procedures, including screening evaluations 2. DSM-V diagnosis of schizophrenia or schizophrenia-spectrum disorder according to MINI interview 3.Age between 18 and 65 years 4.Total Positive and Negative Syndrome Scale (PANSS) score = 75 at V0 5.Stable antipsychotic treatment dose for at least one week prior to inclusion 6.Stable CNS-active treatment substance and dose (e.g. antidepressants and mood stabilizers) for at least one week prior to inclusion 7.Female participants with reproductive potential must have a negative beta-HCG serum pregnancy test using a pregnancy test strip as part of the screening visit 8.Female participants with reproductive potential must have a negative serum pregnancy test within seven days prior to randomization 9.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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 88 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1.Patients who are unable to give informed consent 2.Coercive treatment at the time of study inclusion 3.Treatment-naïve schizophrenia defined as cumulative treatment with an antipsychotic agent lifetime for 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 6.Known clinically relevant CNS disorder(s), such as epilepsy or history of seizures 7.Concomitant use of any other putative remyelinating therapy as determined by investigator 8.Co-occurrent unstable somatic condition 9.Known porphyria 10.Known narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy with urinary retention and bladder neck obstruction 11.Current treatment with agents with strong anticholinergic properties, such as MAO-inhibitors, opioid antagonists, clozapine at the time of study inclusion 12.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) 13.Clinically relevant liver and/or renal impairment (serum creatinine >1.5mg/dl or eGFR 2-times the upper limit of normal at screening) 14.Current treatment with macrolide-antibiotics (such as erythromycin, clarithromycine) or azole-type antimycotics 15.Clinically relevant cardiac comorbidities (i.e. Long QT-syndrome) 16.Current hypokalaemia and/or clinically relevant hyponatraemia at screening 17.Patient-reported hereditary galactose-intolerance and/or Lapp lactose-deficiency, lactose intolerance and/or glucose-galactose malabsorption 18.Pregnancy or breast-feeding 19.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. 20.For the optional MRI assessments: potential MRI contraindication(s)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective 1 is the change in Global Assessment of Functioning (GAF) scores from the start of the intervention period (V1.1) to primary outcome visit after 90-93 days of treatment (V2). The primary objective 2 is the change in working memory performance assessed by the n-back test (2-back level, d-prime) from V1.1 to V2. ;Secondary Objective: •Change in total PANSS scores at V2 compared to baseline •Change in Clinical Global Impression (CGI) rating scale at V2 compared to baseline •Change in remission criteria (“Andreasen Remission criteria”) status from V2 compared to baseline •Change in GAF and n-back scores (2-back, d-prime) from V3 compared to V2 ;Primary end point(s): 1. Absolute change in working memory performance assessed by the n-back test (2-back, d-prime) after 90-93 days of treatment. 2. Absolute change in GAF score after 90-93 days of treatment. ;Timepoint(s) of evaluation of this end point: Baseline (V1.1) to 90-93 days (V2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Change in total PANSS scores at V2 compared to baseline •Change in Clinical Global Impression (CGI) rating scale at V2 compared to baseline •Change in remission criteria (“Andreasen Remission criteria”) status from V2 compared to baseline •Change in GAF and n-back scores (2-back, d-prime) from V3 compared to V2 Exploratory endpoint(s): •Change in Calgary Depression Scale for Schizophrenia (CDSS) score at V2 compared to baseline •Change in World Health Organization Quality of Life Brief Version (WHO-QOL-BREF) at V2 compared to baseline •Change in verbal memory and fluency, motor speed, attention, speed of information processing, working memory, executive functions, and global cognition according to the Brief Assessment of Cognition in Schizophrenia (BACS) and change in attention span and executive functions in the Trail Making Test (TMT) A & B at V2 compared to baseline •Change in Physical fitness at V2 compared to baseline: Physical working capacity (PWC130: power [W] at a heart rate of 130 beats per minute, power [W] at fixed values of lactate concentrations) •Change in weight, waist-to-hip-ratio after 3 months compared to baseline •Change in Physical activity at V2 compared to baseline: Simple Physical Activity Questionnaire (SIMPAQ), actimetry. •Change in 3T MRI at V2 (day 90-93): structural MRI (T1-MPRAGE, T2-SPACE), DTI, resting-state MRI and ASL, all compared to baseline •Change in shortening of P100 latency delay on VEPs at V2 compared to baseline. •Change in Functional Remission of General Schizophrenia (FROGS) scale at V2 compared to baseline •Change in Fatigue Scale for Motor and Cognitive Functions (FSMC) at V2 compared to baseline •Change in Internal-External Locus of Control Scale (IE-4), Resilience (BRS), Selfefficacy (ASKU) and exercise-related selfefficacy (SSA) at V2 compared to baseline and associations to training adherence •Change in Exercise Motivations Inventory and Exercise Motives and Gains Inventory (EMI-2) at V2 | — |
Countries
Germany
Contacts
Public ContactDr. med. Christiane Blankenstein
TUM School of Medicine and Health, Münchner Studienzentrum
Outcome results
None listed