Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03911726 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 5 months later Dec 31, 2025 → Jun 2028
See other at-risk trials from Central Institute of Mental Health, Mannheim

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 31, 2025 to Jun 2028
    • Enrollment reopened
    • Site details revised
    v10
  2. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v9
  3. Eligibility criteria revised
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site contact updated
    v8
  4. Primary and study completion dates: Jul 1, 2023 to Dec 31, 2024v7
  5. Primary and study completion dates: Jul 1, 2022 to Jul 1, 2023v6
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 1, 2020 to Aug 1, 2020
    • Site details revised
    v5
  2. Start date: May 1, 2020 to Jul 1, 2020v4
  3. Primary and study completion dates: Jul 1, 2021 to Jul 1, 2022
    • Start date: Jul 1, 2019 to May 1, 2020
    v3
  4. Interventions: single PET/MR-measurement (Radiation) to Single PET/MR-measurement (Radiation)
    • Study description revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03911726
Lead Sponsor Central Institute of Mental Health, Mannheim
Conditions
(from sponsor)		 Schizophrenia
Related terms Schizophrenia
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov