R33: Levetiracetam in Early Psychosis
- Registration Number
- NCT04317807
- Lead Sponsor
- NYU Langone Health
- Brief Summary
This is a 12-week study of levetiracetam added to a second generation antipsychotic in early psychosis patients who have been ill for less than 5 years and continue to experience psychotic symptoms despite at least 8 weeks of antipsychotic treatment. Levetiracetam (Keppra) is a medication approved for the treatment of epilepsy; it reduces excessive activity in the brain. This study will test the hypotheses that adding levetiracetam will improve psychotic symptoms that are unresponsive to antipsychotic treatment and will protect the brain from atrophy (volume loss). .
- Detailed Description
Participants will complete screening and baseline visits before being randomized in a 2:1 ratio to levetiracetam or placebo added to the antipsychotic medication. They will complete weekly study visits for the first 4 weeks (Baseline, Weeks 2-4) and then additional visits at Week 6, 8, and 12. Participants will be studied both by assessing change in symptom severity and cognitive performance over the 12 weeks as well as using an imaging measure of hippocampal volume integrity at baseline and week 12. After completing Week 12 or decision to withdraw prematurely from the study, participants will complete a 9 day medication tapering regimen.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Drug group Levetiracetam Pill Participants in this group will receive 500 mg of levetiracetam twice daily for 12 weeks. After 12 weeks, levetiracetam will be gradually decreased and stopped over the next 9 days. Questionnaires will be administered at each visit to examine how participants are responding to the treatment. In addition, a brain scan and cognitive testing will be performed when feasible at the beginning and the end of the study. Placebo Group Placebo Participants in this group will receive a placebo that looks like the levetiracetam pill twice daily for 12 weeks. After 12 weeks, the levetiracetam dose will be tapered for the next 9 days. Questionnaires will be administered at each visit to examine how participants are responding to the treatment. In addition, a brain scan and cognitive testing will be performed when feasible at the beginning and the end of the study.
- Primary Outcome Measures
Name Time Method Change in BPRS total score Baseline visit (week 0), Week 12 visit The efficacy of levetiracetam 500 mg bid vs. placebo on symptoms will be measured by the BPRS total score. Brief Psychiatric Rating Scale (BPRS) is an 18-item scale that measures positive symptoms, negative symptoms, general psychopathology and affective symptoms. Individual items are scored on a seven point likert scale. The total score is the sum of responses and ranges from 18 to 126; a higher score on the BPRS items indicates increased severity of symptoms.
- Secondary Outcome Measures
Name Time Method Change in BPRS Psychosis Subscale Baseline visit (week 0), Week 12 visit Brief Psychiatric Rating Scale (BPRS) is an 18-item scale that measures positive symptoms, negative symptoms, general psychopathology and affective symptoms. Individual items are scored on a seven point likert scale. The Psychosis subscale comprises 4 items of the BPRS. The total subscale score is the sum of responses and ranges from 4 to 42; a higher score indicates increased severity of symptoms.
Change in SANS Total Score Baseline visit (week 0), Week 12 visit The Scale for Assessment of Negative Symptoms (SANS) will be the instrument for measurement of negative symptoms. SANS is a 19-tiem assessment; each item is rated on a scale from 0-5. The total score is the sum of the 19 individual item ratings and ranges from 0-95; higher scores indicate greater presence of negative symptoms.
Change in MATRICS Total Score Baseline visit (week 0), Week 12 visit Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery is the standard tool for assessing cognitive change in trials of cognitive-enhancing agents in schizophrenia. The assessment comprises ten individual tests to produce; the scores are converted into a standardized overall composite score, with a mean of 50 and a standard deviation of 10; higher scores indicate better cognitive performance.
Change in Hippocampal Volumetric Integrity Baseline visit (week 0), Week 12 visit Assessed via MRI scan.
Change in Hippocampal Cerebral Blood Flow (CBF) Baseline visit (week 0), Week 12 visit CBF measured using arterial spin labeling (ASL).
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸New York, New York, United States
NYU Langone Health🇺🇸New York, New York, United States