DSM-5 Schizophrenia F20
Conditions
Interventions
Group 1: Ketamine group: Ketamin-Ratiopharm 500 solution for injection (2mg/mL solution) via venous catheter, constant target plasma concentration of 100ng/mL throughout the entire examination
Group 2
ICD10 F20), untreated
Group 4: Healthy controls, untreated
Sponsors
Institut für Psychologie, Rheinische Friedrich-Wilhelms Universität Bonn
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: For ketamine/placebo: physically and mentally healthy, high or low schizotype (SPQ total value in the top 25% or bottom 10%), currently no medication or drug abuse and never ketamine abuse; For control group: physically and mentally healthy, no DSM 5 diagnosis; For patients: DSM-5 diagnosis of schizophrenia; For all groups: right-handed, non-smoking, normal or contact lens-corrected vision; For women: negative pregnancy test
Exclusion criteria
Exclusion criteria: For ketamine/placebo and healthy control group: diagnosis of a mental disorder or depression (current or past), current psychiatric diagnosis or ultra-high risk of psychosis, diagnosis of a neurological disorder (current or past); For ketamine/placebo: Current participation in drug trial, previous use of ketamine or phencyclidine, use of drugs, alcohol, or nicotine on the day of the examination, existing contraindications to ketamine administration; For all groups: Drug addiction (current or past), drug abuse (within the last 6 months), loss of consciousness for more than 30 minutes, claustrophobia (claustrophobia) or ever had a panic attack in a confined space, metal parts in the body or hair (earrings, piercings), large tattoos in the upper half of the body, metallic implants, prostheses, pacemakers or medication pumps (e.g. insulin pumps), BMI of 29 for men or 30 for women, hypertension or hypotension, bradycardia, or tachycardia, spectacle wearer (contact lenses are not a problem), taking antipsychotic drugs for more than 6 months in the past year (allowed are: Risperidone: 4mg/d, Quetiapine: 600mg/d, Olanzapine: 10mg/d, Amisulpride: 400mg/d, Ziprasidone: 40mg/d, Asenapine: 10mg/d, Aripiprazole: 10mg/d, Cariprazine: 3mg/d, Haloperidol: 10mg/d, Benperidol: 4mg/d, Zuclopentoxiol: 20mg/d, Flupentoxiol: 10mg/d, Fluphenazine: 10mg/d); For women: Contraception by means of copper IUD, current pregnancy, current breastfeeding or no effective contraception for more than one cycle
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study aims to further knowledge on the involvement of glutamate in the schizophrenia spectrum. Thus, the first objective is to directly test the hypothesis that there are alterations in the glutamatergic system in schizotypy. Individuals scoring high and low in schizotypy will be assessed on a number of biomarkers while receiving ketamine or a placebo. Selected biomarkers are chosen for their known involvement in schizophrenia and suspected susceptibility to glutamatergic manipulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The same biomarkers that are obtained from the sample stratified for schizotypy will be assessed for patients with schizophrenia in the absence of ketamine. Biomarker results will then be compared for high and low schizotypy with or without ketamine and schizophrenia. This comparison is established to further knowledge of glutamatergic dysfunction in schizophrenia and provide further information on the ketamine-model of schizophrenia. | — |
Countries
Germany
Contacts
Public ContactPhiline Baumert
Institut für Psychologie, Rheinische Friedrich-Wilhelms Universität
Outcome results
None listed