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NCT04559529CompletedPhase 2

Pharmacological Modulation of Hippocampal Activity in Psychosis 2

Source: ClinicalTrials.gov · Last updated 5 Feb 2024

Brief summary (registry, in English)

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 in people with psychotic disorders. Specifically, the investigators will utilize two functional magnetic resonance imaging (MRI) techniques: 1) blood-oxygen-level-dependent (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. 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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
62 (actual)
First submitted
16 Sept 2020
Start date
23 Sept 2020
Primary completion date
31 Dec 2023
Lead sponsor
Vanderbilt University Medical Center
NCT number
NCT04559529

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 62
  • From 23 Sept 2020 to the primary completion date, 31 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current use of psychotropic or potentially psychoactive prescription medication.

Other illness

  • Current medical or neurological illness.
  • History of severe head trauma.
  • Meets criteria for diagnosis of substance or alcohol use disorder within the past month.
  • Conditions that preclude MR scanning (as defined in the Screening Form)
  • Conditions that preclude study drug administration (as defined in the Screening Form)
  • Major psychiatric disorder as determined by Diagnostic and Statistical Manual -5 (major depression, bipolar disorder, obsessive compulsive disorder, post-traumatic stress disorder, etc)

Age

  • Age less than 18 or greater than 65.

Other

  • Not communicative in English.
  • Unable to provide written informed consent.
  • BMI \< 17.5 or \> 45.
  • Positive urine pregnancy test during the study.
  • Breastfeeding/nursing at time of screening or at any time during the study.
  • All of the above and in addition:

Who the study is looking for

  • 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 Diagnostic and Statistical Manual-5 (SCID) or diagnostic interview with a trained clinician.
  • 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 (e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap \[diaphragm or cervical/vault caps\] with spermicidal foam/gel/film/cream/suppository; male partner sterilization; or true abstinence when this is in line with the preferred and usual lifestyle of the subject); and,
  • For females of child-bearing potential, must have a negative urine pregnancy test before MRI and drug administration.
  • Not breastfeeding/nursing at time of screening or at any time during the study.
  • 1\. All of the above except for subjects will be psychiatrically healthy and not taking psychotropic or potentially psychoactive prescription medication.
  • \----

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Vanderbilt University Medical Center
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.