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Do Antipsychotic Agents Induce Supersensitivity in Humans: A Combined PET/MRI Study in Patients With Schizophrenia

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of the present study is to detect changes in the dopamine system in the brain of patients with schizophrenia, especially when pretreated with antipsychotic medication. Here, the investigators want to find out whether the treatment with these drugs can cause permanent changes in docking points (receptors) of dopamine in the brain. It will be examined whether number and response of dopamine receptors is altered, which are associated with the onset of psychotic symptoms. For this purpose, a single PET/MR measurement will be performed in all participants. In total 140 volunteers, consisting of 30 healthy volunteers, 20 first-episode, drug-naive patients with schizophrenia and 90 pretreated patients with schizophrenia will be included over a time period of three years. In addition, the influence of nicotine consumption on dopamine receptors will be invesitgated by comparing data from smoking and non-smoking patients. In clinical practice, an elevation of dopamine action caused by alterations in receptors in the brain is of most importance. This may be the reason why the treatment with antipsychotic agents does not work in some patients. In addition, a permanent elevation of dopamine action is associated with permanent brain alterations by these drugs. The result can contribute to work out valuable indications, whether it makes sense to continue a long term therapy with antipsychotic drugs in a patient. But also the in-depth understanding of the impact of nicotine on the course of therapy can help to open up possibilities for improved drug treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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 Mini International Neuropsychiatric Interview (M.I.N.I.)).

• 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.

Locations
Other Locations
Germany
Central Institute of Mental Health
RECRUITING
Mannheim
Contact Information
Primary
Gerhard Gründer, Prof. Dr.
gerhard.gruender@zi-mannheim.de
+49621 1703-1900
Backup
Christian Schmitz
Christian.Schmitz@zi-mannheim.de
+49621 1703-2411
Time Frame
Start Date: 2020-08-01
Estimated Completion Date: 2028-06
Participants
Target number of participants: 140
Treatments
Other: Healthy subjects
30 healthy subjects will undergo a single PET/MR-measurement.
Experimental: First-episode, drug-naive patients with schizophrenia
20 first-episode, drug-naive patients with schizophrenia will undergo a single PET/MR-measurement.
Experimental: Pretreated chronically ill patients with schizophrenia
90 pretreated chronically ill patients with schizophrenia will undergo a single PET/MR-measurement.
Related Therapeutic Areas
Sponsors
Leads: Central Institute of Mental Health, Mannheim

This content was sourced from clinicaltrials.gov