Patients with schizophrenia and related non-affective psychotic disorders, corresponding to ICD-10 diagnoses F10.5-19.5, and F20-29. MedDRA version: 13.1 Level: HLGT Classification code 10039628 Term: Schizophrenia and other psychotic disorders System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Solian
Product Name: Amisulpride
Pharmaceutical Form: Tablet
INN or Proposed INN: AMISULPRIDE
CAS Number: 71675859
Current Sponsor code: Solian
Other descriptive name: Solian
Concentration
Sponsors
Haukeland University Hospital, Division of Psychiatry
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Patients 18 years and more with symptoms of active psychosis as determined by a score of 4 or more on one or more of the items Delusions, Hallucinatory behavior, Grandiosity, Suspiciousness/ persecution, or Unusual thought content in the Positive and Negative Syndrome Scale (PANSS). b) Fullfilling the diagnostic criteria for one or more of the following ICD-10 diagnoses: F10.5, F11.5, F12.5, F13.5, F14.5, F15.5, F16.5, F17.5, F18.5, F19.5; F20-29. c) Antipsychotic drug therapy indicated using the oral formulation of the drugs. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: a) Diagnosis of affective psychosis b) Unable to comply with study protocol c) Does not understand the language spoken at the investigation site. d) Patients with organic psychosis due to limbic encephalitis e) Pregnant or breast feeding women f)Hypersensitivity to active ingredient or any of the excipients g) Prolactin-dependent tumours h) Use of drugs which could induce torsade de pointes i) Phaeochromocytoma j) Use of levodopa k) Known risk of narrow-angle glaucoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the clinical effectiveness of amisulpride, aripiprazole, and olanzapine, in patients with schizophrenia and related psychotic disorders, in a head-to-head pragmatic, randomized trial funded independently of the pharmaceutical industry; and , through a translational approach, to link drug-induced changes in symptoms, neurocognitive functioning and side effects, to changes in biological substrates on neurochemical, functional and structural levels. .;Secondary Objective: In the randomized, head-to-head design, among the IMPs: 1. Compare the drugs with regards to cognitive functions localized in prefrontal cortex and the corresponding brain activation, change of cortical thickness, and myelin sheath regeneration. 2. Compare effects on mood symptoms and suicidal behaviour. 3. Compare akathisia by objective measurements. 4. Compare heart rate variability. 5. Compare antipsychotic-induced differential gene expression related to lipid metabolism in patients. 6. Compare inflammation markers associated with cardiovascular disease and general inflammation. ;Primary end point(s): The primary end point will be differences among the treatment groups with regards to change of the PANSS positive subscale score at 12 months. ;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end points will be differences among the treatment groups with regards to the following outcome measures: The patients will be tested at baseline and thereafter at weeks 1, 3, 6; months 3,6, 9, and 12 after baseline. The other assessment include: 5.2 Assessments at baseline 5.2.1 General Demographics, prior/ present mental/ physical illness, drug/ alcohol/ smoke. 5.2.2 Diagnostics SCID1 diagnostic interview 5.3 Repeated assessments (baseline; weeks 1,3,6; months 3,6,9,12) 5.3.1 Physical Blood pressure, Body mass index (BMI), waist and hip ratios. 5.3.2 Psychometric tools/ side effect rating scales The Positive And Negative Syndrome Scale; The revised Beliefs About Voices Questionnaire; The Calgary Depression Scale for Schizophrenia; The Clinical Global Impression Scale – Severity of illness; The Global Assessment of Functioning scale – Split version ; the Drake Scale (the alcohol and drug use scale); AUDIT/ DUDIT; The UKU Side Effect Rating Scale; Insight scale; Suicide scale; Young Mania Scale 5.3.3 Neurocognitive tests The battery includes tests of executive functioning and attention/working memory, assessing functions localized to frontal brain regions more likely to be influenced by medication effects. 5.3.4 Laboratory ECG; Blood: General blood screen, CRP, ALAT, ASAT, GT, Albumin, Na, K, Ca, Kreatinin, Serum lipids, glucose, C-peptide, HbA1c, Thyroid status, Prolactin, sex hormones, bone turnover markers, serum level of antipsychotic drug, inflammatory markers (cytokines IFN?, TNFa, IL2, IL4, IL6, IL10) markers of enkothelial activation (E-selectin, ICAM-1, VCAM-1, von Willebrand factor), antibodies, such as NMDAR, VGKC and paraneoplastic antibodies. ; Genetics: DNA, RNA; Urin: Drug screen, Pregnancy test 5.4 Functional and structural MRI (Baseline and repeated) ;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Austria, Norway
Contacts
Public ContactDepartment of Research, Sandviken
Haukeland University Hospital, Division of Psychiatry, Department of Research
Outcome results
None listed