Testing Levetiracetam for hippocampal hyperactivation

Exclusion

• −History of hypersensitivity to levetiracetam or any other ingredients in the study drug or placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
• −Significant neurological disease, including but not limited to:
• −Any type of cognitive impairment
• −History of transient ischemic attacks within 12 months of ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →
• −History of seizures within 12 months of Screening
• −Parkinson's disease
• −Stroke (aside from subcortical lacunar infarcts)
• −Multiple sclerosis
• −Huntington's disease
• −Normal pressure hydrocephalus
• −Brain tumour (aside from benign tumours without mass effect, which are to be judged on a case-by-case basis)
• −Subdural hematoma
• −History of traumatic brain injury with persistent neurological deficits
• −Known structural brain abnormalities
• −Significant or unstable psychiatric disease, including but not limited to:
• −Schizophrenia
• −Bipolar disorder
• −Major depression which is not controlled in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
• −Score ≥10 on the Geriatric Depression Scale (GDS) at Screening
• −Presence of active suicidal ideation within the last 3 months as indicated by "yes" response to Question 4 or 5 on the Suicidal Ideation portion of the C-SSRS at Screening
• −Answered "yes" to any of the suicide-related behaviours within the last 3 months on the Suicidal Behavior portion of the C-SSRS
• −Hospitalized or treated for suicidal behavior within 5 years of Screening
• −Psychotic features, agitation, or behavioral problems within the last 3 months that could lead to difficulty complying with the protocolProtocolThe detailed plan a study must follow.Read more → in the opinion of the investigator
• −Known or suspected history of drug or alcohol abuse or dependence within 2 years before Screening).
• −Significant or unstable systemic illness or medical condition that would in the investigator's judgment make the participant unsuitable for inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → in the study, including but not limited to:
• −History of malignancy within 3 years of screening (except of basal or squamous cell carcinoma of the skin)
• −Moderate-severe chronic kidney disease, chronic obstructive pulmonary disease, or congestive heart failure
• −Any of the following findings on a current (completed during screening) or previous brain MRI/CT scan:
• −Severe white matter disease (Fazekas score66 = 3)
• −Stroke involving a major vascular territory
• −Subcortical lacunar infarcts \>1.5cm in diameter
• −Encephalomalacia
• −Vascular malformations that are at high risk of hemorrhage
• −Infective lesions
• −Space-occupying lesions
• −Any other abnormality that would in the opinion of the investigator make the participant unsuitable for participation in the study
• −Any contraindications to MRI or MEG (e.g., pacemaker, ferromagnetic metal implants, claustrophobia).
• −Treatment with the following medications at time of screening or while in the study:
• −Anticonvulsant medications (unless taken for a different indication than seizures)
• −Methotrexate
• −eGFR \<50ml/min/1.73m2 on screening bloodwork.
• −QTc interval \>470 msec (males) or \>480 msec (females) on screening ECG.
• −Clinically significant abnormal results on screening bloodwork that would in the opinion of the investigator make the participant unsuitable for inclusion in the study.