Schizophrenia; PsychosisPhase 2NCT04277936
Pharmacologic Modulation of Hippocampal Activity in Psychosis
A Phase 2 study testing Levetiracetam 500 mg in people with Schizophrenia; Psychosis, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia; Psychosis
- What is being tested?
- Levetiracetam 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2020to 31 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women age 18 - 65.
- Communicative in English.
- Provide voluntary, written informed consent.
- Physically healthy by medical history.
- BMI > 17.5 and < 45.
- Diagnosis of a psychotic disorder confirmed by Structured Clinical Interview for DSM-V (SCID) or diagnostic interview with a trained clinician.
Show all 11Show fewer
- Stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication.
- For females, no longer of child-bearing potential, or agreeing to practice effective contraception during the study; and,
- For females of child-bearing potential, must have negative urine pregnancy test at time of screening visit and before each testing day.
- Not breastfeeding/nursing at time of screening or at any time during the study.
- 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.
Who cannot join
- Age less than 18 or greater than 65.
- Not communicative in English.
- Unable to provide written informed consent.
- Current medical or neurological illness.
- History of severe head trauma.
- BMI < 17.5 or > 45.
Show all 14Show fewer
- Meets criteria for diagnosis of substance or alcohol use disorder within the past month.
- Positive urine pregnancy test at time of screening, before each testing day, or any potential concern for pregnancy at any time during the study.
- Breastfeeding/nursing at time of screening or at any time during the study.
- Conditions that preclude MR scanning
- Conditions that preclude study drug administration
- All of the above and in addition:
- Current use of psychotropic or potentially psychoactive prescription medication.
- Major psychiatric disorder as determined by DSM-V (major depression, bipolar disorder, obsessive compulsive disorder, post-traumatic stress disorder, etc)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
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.
- Conditions
- Schizophrenia; Psychosis
- Being tested
- Levetiracetam 500 mg
- Keywords
- Hippocampus
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levetiracetam 500 mgDrug
Also called Keppra
Levetiracetam (LEV) regulates neuronal synaptic exocytosis and calcium-induced neurotransmitter release and has a therapeutic effect on the excitation-inhibition balance of the hippocampus.
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam (LEV) 500 mg | Experimental | 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. Receives: Drug: Levetiracetam 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hippocampal Activity (Arterial Spin Labeling [ASL] Study)
Change in ASL signal after drug administration
Measured: 2 hours and 2 weeks after administration
Hippocampal Recruitment (BOLD Study)
Change in BOLD signal after drug administration
Measured: 2 hours and 2 weeks after administration
Secondary outcomes (2)
Cognitive Symptoms
Change in eye-tracking relational memory task
Measured: 2 weeks after administration
Positive and Negative Symptoms
Change PANSS score
Measured: 2 weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start11 May 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Why it stopped: Study was redesigned and submitted as a new protocol (NCT04559529).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Schizophrenia; PsychosisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan Heckers, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277936
- Sponsor's protocol ID
- VEPP_200218
- Status last verified
- Jul 2021
- First submitted
- 18 Feb 2020
- Last updated
- 5 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacologic Modulation of Hippocampal Activity in Psychosis
- ClinicalTrials.gov ID
- NCT04277936
- Acronym / sponsor ID
- VEPP_200218
- Conditions
- Schizophrenia; Psychosis
- Keywords
- Hippocampus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was redesigned and submitted as a new protocol (NCT04559529).
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Posted 5 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam (LEV) 500 mg | Experimental | Drug: Levetiracetam 500 mgParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women age 18 - 65.
- Communicative in English.
- Provide voluntary, written informed consent.
- Physically healthy by medical history.
- BMI > 17.5 and < 45.
Key exclusion criteria (14 listed)
- Age less than 18 or greater than 65.
- Not communicative in English.
- Unable to provide written informed consent.
- Current medical or neurological illness.
- History of severe head trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levetiracetam 500 mgAlso: KeppraLevetiracetam (LEV) regulates neuronal synaptic exocytosis and calcium-induced neurotransmitter release and has a therapeutic effect on the excitation-inhibition balance of the hippocampus. | Drug | Levetiracetam (LEV) 500 mg |
Primary outcome
Hippocampal Activity (Arterial Spin Labeling [ASL] Study)
Time frame: 2 hours and 2 weeks after administration
Change in ASL signal after drug administration
Hippocampal Recruitment (BOLD Study)
Time frame: 2 hours and 2 weeks after administration
Change in BOLD signal after drug administration
2 secondary outcomes
Cognitive Symptoms
Time frame: 2 weeks after administration
Positive and Negative Symptoms
Time frame: 2 weeks after administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia; Psychosis
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levetiracetam 500 mg in people with Schizophrenia; Psychosis, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hippocampal Activity (Arterial Spin Labeling [ASL] Study) (time frame: 2 hours and 2 weeks after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.