Trial Outcomes & Findings for Pharmacologic Modulation of Hippocampal Activity in Psychosis (NCT NCT04277936)

NCT ID: NCT04277936

Last Updated: 2021-08-05

Results Overview

Change in ASL signal after drug administration

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 2 hours and 2 weeks after administration
• Results posted on: 2021-08-05

Participant Flow

Participant milestones

Measure	Levetiracetam (LEV) 500 mg 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. Levetiracetam 500 mg: Levetiracetam (LEV) regulates neuronal synaptic exocytosis and calcium-induced neurotransmitter release and has a therapeutic effect on the excitation-inhibition balance of the hippocampus.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacologic Modulation of Hippocampal Activity in Psychosis

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 2 hours and 2 weeks after administration

Population: Data were collected for a single subject, but study design was changed and study was discontinued.

Change in ASL signal after drug administration

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 hours and 2 weeks after administration

Population: Data were collected for a single subject, but study design was changed and study was discontinued.

Change in BOLD signal after drug administration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks after administration

Population: No data were collected.

Change in eye-tracking relational memory task

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks after administration

Population: Healthy participant; outcome measure does not apply

Change PANSS score

Outcome measures

Outcome data not reported

Adverse Events

Levetiracetam (LEV) 500 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephan Heckers

Vanderbilt University Medical Center

Phone: 6159222665

Email: stephan.heckers@vumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place