Last reviewed · How we verify

NCT03911726

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

Active, enrolled NA Last updated 8 April 2025
What this trial tests

NA trial testing Single PET/MR-measurement in Schizophrenia in 140 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 August 2020
Primary endpoint
31 December 2025
31 December 2025

Quick facts

Lead sponsorCentral Institute of Mental Health, Mannheim
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposebasic science
Enrollment140
Start date1 August 2020
Primary completion31 December 2025
Estimated completion31 December 2025
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Central Institute of Mental Health, Mannheim

Who can join

Adults 18 to 65, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Neurovascular coupling of striatal dopamine D<sub>2/3</sub> receptor availability and perfusion using simultaneous PET/MR in humans.
    Schmitz CN, Hart XM, Spangemacher M, Roth JL, et al · · 2024 · cited 2× · PMID 40656113 · DOI 10.1016/j.nsa.2024.104094

Verify or expand the search:

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

Other Central Institute of Mental Health, Mannheim trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03911726.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing