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Can antipsychotics rewire the Brain's dopamine system? a scan study investigates

NCT ID NCT03911726

Knowledge-focused Sponsor: Central Institute of Mental Health, Mannheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This study uses PET and MRI brain scans to see if antipsychotic medication causes lasting changes in dopamine receptors in people with schizophrenia. Researchers will compare three groups: healthy volunteers, patients who have never taken antipsychotics, and patients who have been treated with these drugs. They also look at how smoking affects dopamine receptors. The goal is to understand why some patients stop responding to treatment and whether long-term therapy is always beneficial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A single PET/MR scan using [18F]Fallypride, with the dopamine receptor agonist apomorphine administered during the scan
What this could lead to
If this works, it could clarify whether long-term antipsychotic use alters dopamine receptors, helping doctors decide when to continue or stop these drugs.
What could go wrong
This is an observational imaging study, not a treatment trial, so it won't directly change patient care. Results may be complex and require further research to confirm.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2020

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Central Institute of Mental Health

    RECRUITING

    Mannheim, Baden-Wurttemberg, 68159, Germany

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