Trial Outcomes & Findings for Pharmacological Modulation of Hippocampal Activity in Psychosis 2 (NCT NCT04559529)
NCT ID: NCT04559529
Last Updated: 2024-02-05
Results Overview
ASL signal after LEV, using Magnetic Resonance Imaging (MRI) scanning of the brain. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
2 hours after LEV administration
Results posted on
2024-02-05
Participant Flow
Participant milestones
| Measure |
Healthy Control Participants: Levetiracetam (LEV), Then Placebo
Healthy control participants will first receive two 250mg LEV capsules on the same day. After one week, they will receive two placebo capsules on the same day.
|
Healthy Control Participants: Placebo, Then Levetiracetam (LEV)
Healthy control participants will first receive two placebo capsules on the same day. After one week, they will receive two 250mg LEV capsules on the same day.
|
Patients With Schizophrenia: Levetiracetam (LEV), Then Placebo
Participants with schizophrenia will first receive two 250mg LEV capsules on the same day. After one week, they will receive two placebo capsules on the same day.
|
Patients With Schizophrenia: Placebo, Then Levetiracetam (LEV)
Participants with schizophrenia will first receive two placebo capsules on the same day. After one week, they will receive two 250mg LEV capsules on the same day.
|
|---|---|---|---|---|
|
First Intervention (1 Day)
STARTED
|
15
|
15
|
15
|
17
|
|
First Intervention (1 Day)
COMPLETED
|
15
|
15
|
14
|
16
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
1
|
1
|
|
Washout (At Least 7 Days)
STARTED
|
15
|
15
|
14
|
16
|
|
Washout (At Least 7 Days)
COMPLETED
|
15
|
15
|
14
|
16
|
|
Washout (At Least 7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
15
|
15
|
14
|
16
|
|
Second Intervention (1 Day)
COMPLETED
|
15
|
15
|
13
|
16
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Healthy Control Participants: Levetiracetam (LEV), Then Placebo
Healthy control participants will first receive two 250mg LEV capsules on the same day. After one week, they will receive two placebo capsules on the same day.
|
Healthy Control Participants: Placebo, Then Levetiracetam (LEV)
Healthy control participants will first receive two placebo capsules on the same day. After one week, they will receive two 250mg LEV capsules on the same day.
|
Patients With Schizophrenia: Levetiracetam (LEV), Then Placebo
Participants with schizophrenia will first receive two 250mg LEV capsules on the same day. After one week, they will receive two placebo capsules on the same day.
|
Patients With Schizophrenia: Placebo, Then Levetiracetam (LEV)
Participants with schizophrenia will first receive two placebo capsules on the same day. After one week, they will receive two 250mg LEV capsules on the same day.
|
|---|---|---|---|---|
|
First Intervention (1 Day)
Adverse Event
|
0
|
0
|
0
|
1
|
|
First Intervention (1 Day)
Withdrawn due to inability to complete imaging
|
0
|
0
|
1
|
0
|
|
Second Intervention (1 Day)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Pharmacological Modulation of Hippocampal Activity in Psychosis 2
Baseline characteristics by cohort
| Measure |
Healthy Control Participants: Levetiracetam (LEV), Then Placebo
n=15 Participants
Healthy control participants will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill. About 2 hours before the second imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam.
|
Healthy Control Participants: Placebo, Then Levetiracetam (LEV)
n=15 Participants
Healthy control participants will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. About 2 hours before the second imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill.
|
Patients With Schizophrenia: Levetiracetam (LEV), Then Placebo
n=14 Participants
Patients with schizophrenia will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill. About 2 hours before the second imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam.
|
Patients With Schizophrenia: Placebo, Then Levetiracetam (LEV)
n=16 Participants
Patients with schizophrenia will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. About 2 hours before the second imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
36.0 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
35.7 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
34.8 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
34.7 years
STANDARD_DEVIATION 11.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
14 participants
n=5 Participants
|
16 participants
n=4 Participants
|
60 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 hours after LEV administrationPopulation: The overall number of participants analyzed is inconsistent with the numbers provided in the participant flow module due to MRI scanner or participant error during the collection of the ASL sequence. However, these participants still included useful imaging data collected in other imaging sequences during the study.
ASL signal after LEV, using Magnetic Resonance Imaging (MRI) scanning of the brain. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
Outcome measures
| Measure |
Patients With Schizophrenia: Levetiracetam (LEV), Then Placebo
n=14 Participants
Patients with schizophrenia will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill. About 2 hours before the second imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam.
|
Healthy Control Participants: Levetiracetam (LEV), Then Placebo
n=15 Participants
Healthy control participants will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill. About 2 hours before the second imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam.
|
Healthy Control Participants: Placebo, Then Levetiracetam (LEV)
n=14 Participants
Healthy control participants will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. About 2 hours before the second imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill.
|
Patients With Schizophrenia: Placebo, Then Levetiracetam (LEV)
n=14 Participants
Patients with schizophrenia will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. About 2 hours before the second imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill.
|
|---|---|---|---|---|
|
Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Levetiracetam (LEV)
|
28.0 ml/100g/min
Interval 24.7 to 31.3
|
28.3 ml/100g/min
Interval 25.2 to 31.3
|
27.1 ml/100g/min
Interval 24.9 to 29.4
|
28.5 ml/100g/min
Interval 25.5 to 31.5
|
PRIMARY outcome
Timeframe: 2 hours after placebo administrationPopulation: The overall number of participants analyzed is inconsistent with the numbers provided in the participant flow module due to MRI scanner or participant error during the collection of the ASL sequence. However, these participants still included useful imaging data collected in other imaging sequences during the study.
ASL signal after placebo, using Magnetic Resonance Imaging (MRI) scanning of the brain. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
Outcome measures
| Measure |
Patients With Schizophrenia: Levetiracetam (LEV), Then Placebo
n=13 Participants
Patients with schizophrenia will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill. About 2 hours before the second imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam.
|
Healthy Control Participants: Levetiracetam (LEV), Then Placebo
n=13 Participants
Healthy control participants will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill. About 2 hours before the second imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam.
|
Healthy Control Participants: Placebo, Then Levetiracetam (LEV)
n=15 Participants
Healthy control participants will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. About 2 hours before the second imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill.
|
Patients With Schizophrenia: Placebo, Then Levetiracetam (LEV)
n=14 Participants
Patients with schizophrenia will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. About 2 hours before the second imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill.
|
|---|---|---|---|---|
|
Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Placebo
|
28.1 ml/100g/min
Interval 25.5 to 30.7
|
28.1 ml/100g/min
Interval 25.6 to 30.5
|
28.3 ml/100g/min
Interval 25.2 to 31.4
|
28.7 ml/100g/min
Interval 25.5 to 32.0
|
PRIMARY outcome
Timeframe: 2 hours after LEV administrationPopulation: The overall number of participants analyzed is inconsistent with the numbers provided in the participant flow module due to MRI scanner or participant error during the collection of the recruitment data using the BOLD signal. However, these participants still included useful imaging data collected in other imaging sequences during the study.
BOLD signal after LEV, using Magnetic Resonance Imaging (MRI) scanning of the brain. This method reflects changes in oxygenation of blood in the brain during a scene-processing task that engages, or recruits, the hippocampus.
Outcome measures
| Measure |
Patients With Schizophrenia: Levetiracetam (LEV), Then Placebo
n=13 Participants
Patients with schizophrenia will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill. About 2 hours before the second imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam.
|
Healthy Control Participants: Levetiracetam (LEV), Then Placebo
n=15 Participants
Healthy control participants will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill. About 2 hours before the second imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam.
|
Healthy Control Participants: Placebo, Then Levetiracetam (LEV)
n=14 Participants
Healthy control participants will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. About 2 hours before the second imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill.
|
Patients With Schizophrenia: Placebo, Then Levetiracetam (LEV)
n=11 Participants
Patients with schizophrenia will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. About 2 hours before the second imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill.
|
|---|---|---|---|---|
|
Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Levetiracetam (LEV)
|
0.2915 BOLD percent signal change
Interval 0.1084 to 0.4745
|
-0.0342 BOLD percent signal change
Interval -0.2172 to 0.1489
|
0.1216 BOLD percent signal change
Interval -0.0382 to 0.2813
|
0.2381 BOLD percent signal change
Interval -0.0078 to 0.484
|
PRIMARY outcome
Timeframe: 2 hours after placebo administrationPopulation: The overall number of participants analyzed is inconsistent with the numbers provided in the participant flow module due to MRI scanner or participant error during the collection of the recruitment data using the BOLD signal. However, these participants still included useful imaging data collected in other imaging sequences during the study.
BOLD signal after placebo, using Magnetic Resonance Imaging (MRI) scanning of the brain. This method reflects changes in oxygenation of blood in the brain during a scene-processing task that engages, or recruits, the hippocampus.
Outcome measures
| Measure |
Patients With Schizophrenia: Levetiracetam (LEV), Then Placebo
n=12 Participants
Patients with schizophrenia will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill. About 2 hours before the second imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam.
|
Healthy Control Participants: Levetiracetam (LEV), Then Placebo
n=14 Participants
Healthy control participants will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill. About 2 hours before the second imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam.
|
Healthy Control Participants: Placebo, Then Levetiracetam (LEV)
n=14 Participants
Healthy control participants will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. About 2 hours before the second imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill.
|
Patients With Schizophrenia: Placebo, Then Levetiracetam (LEV)
n=14 Participants
Patients with schizophrenia will undergo two MRI scanning sessions. Each session includes two functional magnetic resonance imaging (MRI) techniques:
1. Blood-oxygen-level-dependent (BOLD) contrast to assess activity with a visual scene processing task that engages the hippocampus.
2. Arterial spin labeling (ASL) to assess baseline activity. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
About 2 hours before the first imaging session, they will receive the placebo pill. The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam. About 2 hours before the second imaging session, they will receive levetiracetam (LEV) 500 mg. The levetiracetam pill will look just like the placebo pill.
|
|---|---|---|---|---|
|
Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Placebo
|
0.1769 BOLD percent signal change
Interval -0.0607 to 0.4146
|
0.1908 BOLD percent signal change
Interval -0.0158 to 0.3975
|
0.0507 BOLD percent signal change
Interval -0.1081 to 0.2094
|
0.0703 BOLD percent signal change
Interval -0.1121 to 0.2526
|
Adverse Events
Healthy Control Participants: Levetiracetam (LEV)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Control Participants: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients With Schizophrenia: Levetiracetam (LEV)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients With Schizophrenia: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Control Participants: Levetiracetam (LEV)
n=30 participants at risk
All healthy control participants that received LEV. All individuals contributed data to the study outcomes.
|
Healthy Control Participants: Placebo
n=30 participants at risk
All healthy control participants that received placebo. All individuals contributed data to the study outcomes.
|
Patients With Schizophrenia: Levetiracetam (LEV)
n=31 participants at risk
All patients with schizophrenia that received LEV, including individuals that did not contribute data to the study outcomes.
|
Patients With Schizophrenia: Placebo
n=30 participants at risk
All patients with schizophrenia that received placebo, including individuals that did not contribute data to the study outcomes.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/30 • Up to 4 hours after levetiracetam or placebo administration.
|
0.00%
0/30 • Up to 4 hours after levetiracetam or placebo administration.
|
0.00%
0/31 • Up to 4 hours after levetiracetam or placebo administration.
|
3.3%
1/30 • Number of events 1 • Up to 4 hours after levetiracetam or placebo administration.
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Additional Information
Stephan Heckers, MD; Principal Investigator
Vanderbilt University Medical Center
Phone: 6153222665
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place