Schizophrenia according to DSM-5 F20
Conditions
Interventions
Group 1: 30 healthy subjects will undergo a single PET/MR-measurement.
Group 2: 20 first-episode, drug-naive patients with schizophrenia will undergo a single PET/MR-measurement.
Group 3: 90 pretreate
Sponsors
Zentralinstitut für Seelische Gesundheit
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for healthy subjects: • age: 18-65 • the subject is capable to understand scope and individual consequences of the clinical study. • An informed consent is signed and personally dated by the subject. • No psychiatric disorder (DSM-5) currently, or in the medical history (ensured by a standardized psychiatric interview (DIAX: composite international diagnostic interview)). Inclusion criteria for patients: • age: 18-65 • the criteria for schizophrenia after DSM-5 are met. • The subject is capable to understand scope and individual consequences of the clinical study. • For first-episode patients, no application of antipsychotic drugs in history. Other psychoactive substances (in particular antidepressants) are allowed if last application is at least three months ago and total duration did not exceed three months. Benzodiazepines are allowed. • For medically pretreated patients: at least one year pharmacotherapy with one of the following three substances: aripiprazole or quetiapine or risperidone. A medication break of - depending on the plasma level - two days (quetiapine) up to two weeks (aripiprazole) should be clinically defensible. • An informed consent is signed and personally dated by the patient. For patients with legal support in addition: signature of the legal supervisor.
Exclusion criteria
Exclusion criteria: Exclusion criteria for patients and subjects: • Hypersensitivity against apomorphine or a chemically similar substance or one of the components of the applied medication. • Participation in other clinical trials during or within six months prior to this clinical study. • Medical or psychological conditions which may endanger a proper performance of the clinical trial. • Physical disorders which interfere according to type and severity with the planned examinations, which could influence the parameter to be investigated or could compromise the subject during the examination procedure. • Inability to comply with the study protocol. • Limited or completely repealed legal capacity. • For female participants: positive pregnancy test on the day of the study inclusion or on the day of the PET/MR-measurement. • Acute suicidality or endangerment • Poor general condition. • Participation in a study using ionising radiation within the last five years. • Alcohol abuse, alcohol dependence or addiction disease / abuse of dependence-inducing substances (excluding nicotine) in the history, additional exclusion criterion for healthy subjects: regular medication intake; within the last two weeks before PET/MR-measurement no drugs at all must be taken., Additional exclusion criterion for patients: other than the approved axis I diagnosis according to DSM-5. An axis II diagnosis is not a criterion for exclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcomes will be recorded during the single PET/MR-measurement. In here, the dopamine D2/D3-receptor availability will be measured as binding potential (BP) using PET and blood-oxygen-level-dependent (BOLD)-response will be measured using fMRI. Chronically ill, pretreated patients with schizophrenia show a higher D2/D3-receptor availability than healthy subjects and drug-naive, first-episode patients with schizophrenia. Non-Smoking, chronically ill and pretreated patients with schizophrenia show higher D2/D3-receptor availability than smoking, chronically ill and pretreated patients with schizophrenia. Accordingly, non-smoking patients with schizophrenia show a higher sensitivity to a dopaminergic stimulus than smoking patients with schizophrenia. | — |
Secondary
| Measure | Time frame |
|---|---|
| First-Episode, drug-naive patients with schizophrenia Show a higher D2/3-receptor availability than healthy controls. Higher D2/D3-receptor availability correlates with the sensitivity measured as cerebral hemodynamic reaction to a dopaminergic stimulus. In first-episode, drug-naive patients with schizophrenia, expressions of NSS and AIMS correlate significantly with striatal D2/D3-receptor availability. In first-episode, drug-naive patients with schizophrenia the risk to develop EPS within 12 weeks after the begin of antipsychotic treatment significantly correlates with striatal D2/D3-receptor availability. In pretreated, chronically ill patients with schizophrenia, patients with TD show a significantly higher D2/D3-receptor availability than patients without TD. Patients, treated with an antipsychotic agent with a high affinity to D2-receptors, show a significantly higher D2/D3-receptor availability than patients treated with an antipsychotic agent with a low affinity to D2-receptors or which acts as partial agonists. In pretreated, chronically ill patients with schizophrenia, the D2/D3-receptor availability correlates with the relapse risk and the risk for the development of TD over the course of two years. | — |
Countries
Germany
Contacts
Public ContactGerhard Gründer
Zentralinstitut für Seelische Gesundheit
Outcome results
None listed