Remitted early phase schizophrenia
Conditions
Brief summary
All-cause discontinuation within 12 months following randomization as defined by any of the following conditions: 1) relevant worsening of symptoms; 2) not taking medication as prescribed for more than 14 consecutive days; 3) not keeping appointments as scheduled for more than six weeks; 4) not being traceable despite extensive efforts; withdrawal of informed consent; 6) termination of treatment on investigators request due to clinical reasons
Detailed description
Improvement in Psychopathology from baseline (PANSS, CGI, BSI-53, FROGS), social and occupational functioning (GAF, PSP) and quality of life (WHOQUOL-Bref, LQLP)., Changes from baseline in the Calgary Depression Scale for Schizo-phrenia (CDSS)., Changes from baseline in Neurocognition., Drug Attitude Inventory (DAI) and self-reported treatment adherence., Changes of cumulative dose of concomitant or rescue medication., Changes of biomarkers: alteration in endogenous cannabinoids and lipidomic profiling., Changes from baseline in the UKU Side Effect Rating Scale, Abnormal Involuntary Movement Scale (AIMS) and evaluation of ex-trapyramidal symptoms (EPS)., Columbia Suicidality Severity Rating Scale (C-SSRS)., Other safety and tolerability assessments including (S)AEs, physical examination, abdominal girth, body mass index (BMI), vital signs (including heart rate and systolic and diastolic blood pressure in both supine and standing positions), ECG, assessments for neurological functioning and detailed laboratory assessments.
Interventions
DRUGFüllstoffmischung DAC in hardshell gelatine capsules
DRUGsize 1
DRUGis used as placebo.
Füllstoffmischung DAC consists of mannitol 99.5 % and silloidal silicon dioxide (Aerosil®) 0.5 %.
Sponsors
Zentralinstitut Fuer Seelische Gesundheit
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause discontinuation within 12 months following randomization as defined by any of the following conditions: 1) relevant worsening of symptoms; 2) not taking medication as prescribed for more than 14 consecutive days; 3) not keeping appointments as scheduled for more than six weeks; 4) not being traceable despite extensive efforts; withdrawal of informed consent; 6) termination of treatment on investigators request due to clinical reasons | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in Psychopathology from baseline (PANSS, CGI, BSI-53, FROGS), social and occupational functioning (GAF, PSP) and quality of life (WHOQUOL-Bref, LQLP)., Changes from baseline in the Calgary Depression Scale for Schizo-phrenia (CDSS)., Changes from baseline in Neurocognition., Drug Attitude Inventory (DAI) and self-reported treatment adherence., Changes of cumulative dose of concomitant or rescue medication., Changes of biomarkers: alteration in endogenous cannabinoids and lipidomic profiling., Changes from baseline in the UKU Side Effect Rating Scale, Abnormal Involuntary Movement Scale (AIMS) and evaluation of ex-trapyramidal symptoms (EPS)., Columbia Suicidality Severity Rating Scale (C-SSRS)., Other safety and tolerability assessments including (S)AEs, physical examination, abdominal girth, body mass index (BMI), vital signs (including heart rate and systolic and diastolic blood pressure in both supine and standing positions), ECG, assessments for neurological functioning | — |
Countries
Germany
Outcome results
None listed