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Clinical trial

Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia

ID
Name
MHBB-006-16S
Description
This study plans to learn more about the effects of levetiracetam (LEV) on brain activity and cognition in schizophrenia and schizoaffective disorder. Levetiracetam is an anti-seizure drug, also called an anticonvulsant.
Trial arms
Trial start
2018-09-01
Estimated PCD
2024-06-30
Trial end
2024-06-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Levetiracetam
Anticonvulsant drug
Arms:
Levetiracetam, Then Placebo, Placebo, Then Levetiracetam
Other names:
Keppra
Placebo
Placebo
Arms:
Levetiracetam, Then Placebo, Placebo, Then Levetiracetam
Size
67
Primary endpoint
Neurocognitive function
4 weeks
Eligibility criteria
Inclusion Criteria: * Diagnosis of schizophrenia or schizoaffective disorder * Good general health * Normal vital signs (blood pressure, pulse, respiration) Exclusion Criteria: * Substance abuse * Significant neurological disorders * Significant head trauma/injury * Pregnancy * MRI-specific exclusion criteria, e.g.,: * claustrophobia * weight\>400 lbs * metal in the body
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 67, 'type': 'ACTUAL'}}
Updated at
2023-10-23

1 organization

1 product

1 drug

1 indication

Organization
VA Office of Research and Development
Product
Levetiracetam
Indication
Schizophrenia
Drug
Varlilumab