A Phase 2 interventional study of Levetiracetam 500 mg in Schizophrenia; Psychosis, sponsored by Vanderbilt University Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-05.
Sponsored by Vanderbilt University Medical Center · Phase 2, Interventional, and Basic science
The purpose of this study is to test whether administration of levetiracetam (LEV), a commonly used anti-epileptic that alters neurotransmitter release, can reduce hippocampal hyperactivity. Specifically, we will utilize two functional magnetic resonance imaging (MRI) techniques: 1) blood oxygen level dependence (BOLD) contrast will assess activity with a visual scene processing task that engages the anterior hippocampus and 2) arterial spin labeling (ASL) will assess baseline activity. This study will also assess whether patients have improvement in their symptoms after receiving LEV. Previous studies in people with psychotic disorders have shown that the hippocampus is hyperactive and more activity correlates with worsening of clinical symptoms. Therefore, the aim of this study is to use an intervention to further understand the underlying mechanisms of the hippocampus in psychosis.
3,471 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.
This study's enrollment of 1 is below the median of 70 across 2,871 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for psychosis subjects:
Inclusion criteria for healthy controls All of the above except for subjects will be psychiatrically healthy and not taking psychotropic or potentially psychoactive prescription medication.
Exclusion criteria for psychosis subjects
Exclusion criteria for healthy controls
All of the above and in addition:
Participants will take their first dose of 500 mg LEV. After a two hour time window, the participants will complete MRI study. After MRI, patients will begin a 2-week intervention with 250 mg BID oral LEV.
Drug: Levetiracetam 500 mg
Levetiracetam (LEV) regulates neuronal synaptic exocytosis and calcium-induced neurotransmitter release and has a therapeutic effect on the excitation-inhibition balance of the hippocampus.
Also known as: Keppra
Hippocampal Activity (Arterial Spin Labeling [ASL] Study)
Change in ASL signal after drug administration
Time frame: 2 hours and 2 weeks after administration
Hippocampal Recruitment (BOLD Study)
Change in BOLD signal after drug administration
Time frame: 2 hours and 2 weeks after administration
Cognitive Symptoms
Change in eye-tracking relational memory task
Time frame: 2 weeks after administration
Positive and Negative Symptoms
Change PANSS score
Time frame: 2 weeks after administration
| Milestone | Levetiracetam (LEV) 500 mg |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
Change in ASL signal after drug administration
No measurements were reported for this outcome.
Change in BOLD signal after drug administration
No measurements were reported for this outcome.
Change in eye-tracking relational memory task
No measurements were reported for this outcome.
Change PANSS score
No measurements were reported for this outcome.
Collected over 2 weeks The protocol is: a) single dose of 500mg LEV, b) neuroimaging session #1, c) 500mg LEV for 2-weeks and d) imaging session #2. This participant only took a single 500mg dose and never advanced to the protocol components c) and d), i.e. did not complete the study protocol. 93% of LEV is cleared in 48 hours, so monitoring is not necessary beyond 1 week.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Levetiracetam (LEV) 500 mg | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
Data were collected for a single subject, but study design was changed and study was discontinued. No data were analyzed.
| Age, Categorical | Levetiracetam (LEV) 500 mg |
|---|---|
| <=18 years | — |
| Between 18 and 65 years | — |
| >=65 years | — |
| Age, Continuous | Levetiracetam (LEV) 500 mg |
|---|
| Sex: Female, Male | Levetiracetam (LEV) 500 mg |
|---|---|
| Female | — |
| Male | — |
| Race (NIH/OMB) | Levetiracetam (LEV) 500 mg |
|---|---|
| American Indian or Alaska Native | — |
| Asian | — |
| Native Hawaiian or Other Pacific Islander | — |
| Black or African American | — |
| White | — |
| More than one race | — |
| Unknown or Not Reported | — |
| Region of Enrollment(participants) | Levetiracetam (LEV) 500 mg |
|---|
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Plan to share: No
This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Vanderbilt University Medical Center