euroimaging of NMDA-sensitive Biomarkers in the Schizophrenia Spectrum

Not Applicable

Recruiting

• Conditions: DSM-5 Schizophrenia; F20; Schizophrenia

• Registration Number: DRKS00030631
• Lead Sponsor: Institut für Psychologie, Rheinische Friedrich-Wilhelms Universität Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 208

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

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 < 18 or > 29 for men or < 19 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.