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NCT02034253 · ClinicalTrials.gov registry record
Glutamate, Brain Connectivity and Duration of Untreated Psychosis
A clinical trial, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- 134
- Enrollment target
NCT02034253: Completed study, sponsored by University of Alabama at Birmingham.
NCT02034253 is a clinical trial that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 134 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02034253 has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- 134 participants
- Enrollment target
Study Summary
The early stages of schizophrenia are associated with significant decreases in social and intellectual abilities, with more declines in chronic disease. Studies have identified relationships between duration of untreated psychosis (the duration between the onset of positive symptoms and treatment) and worse long term outcomes. However, the neurobiology of this phenomenon and its implications for response to antipsychotic medications remain poorly understood. Glutamatergic excess altering brain connectivity might provide an explanation for why those with longer duration of untreated psychosis have worse clinical outcomes. The investigators propose to use neuroimaging to study 67 first episode psychosis subjects before and after sixteen weeks of treatment with risperidone, a common antipsychotic. We will measure (1) glutamate and (2) structural and functional brain connectivity and test the hypotheses that glutamatergic abnormalities are present in first episode patients and that longer duration of untreated psychosis is associated with greater connectivity abnormalities that set the stage for poor response to treatment. 67 demographic-matched controls will also be recruited as a comparison group - healthy controls will not receive antipsychotic medication. The investigator's previous studies have made progress in the understanding of abnormalities in the glutamate system and brain connectivity in unmedicated patients with schizophrenia and modulation of these by antipsychotic medication. Two indices of glutamatergic dysfunction have been identified. While antipsychotic medications appear to modulate glutamate, the disturbance in the relationship between metabolites is not restored with treatment. In addition, the investigators found that both structural and functional connectivity abnormalities in unmedicated patients with schizophrenia predict patients' response to treatment. To the investigator's knowledge, no other group has performed a study that uses a combin
Interventions
- DRUG Risperidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2014-01 |
| Est. Completion | 2018-11 |
What the finished NCT02034253 record still lists
NCT02034253 is an observational study that tracks outcomes without assigning an intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Risperidone is the first listed.
NCT02034253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02034253 about?
NCT02034253 is a clinical study titled "Glutamate, Brain Connectivity and Duration of Untreated Psychosis". The early stages of schizophrenia are associated with significant decreases in social and intellectual abilities, with more declines in chronic disease. Studies have identified relationships between duration of untreated psychosis (the duration between the onset of positive symptoms and treatment) a...
What is the current status of trial NCT02034253?
This trial is currently completed. The enrollment target is 134 participants. The study started on 2014-01. Estimated completion is 2018-11.
What interventions are being tested in trial NCT02034253?
The interventions under investigation include: Risperidone (DRUG).
Who is sponsoring clinical trial NCT02034253?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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