Trial · NCT04559529
Pharmacological Modulation of Hippocampal Activity in Psychosis 2
NCT04559529, Phase 2, Completed, Vanderbilt University Medical Center; results first posted 2024-02-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pharmacological Modulation of Hippocampal Activity in Psychosis 2. Trials, record NCT04559529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04559529
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacological Modulation of Hippocampal Activity in Psychosis 2
- NCT number
- NCT04559529
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 62 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Schizophrenia; Psychosis
- Interventions
- Levetiracetam (LEV) 500 mg, Placebo
- First posted
- 2020-09-23
- Last updated
- 2024-02-05
- Results first posted
- 2024-02-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Levetiracetam (LEV) | 2 hours after LEV administration | 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. |
| Primary | Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Placebo | 2 hours after placebo administration | 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. |
| Primary | Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Levetiracetam (LEV) | 2 hours after LEV administration | 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. |
| Primary | Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Placebo | 2 hours after placebo administration | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Levetiracetam (LEV) | 2 hours after LEV administration | 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. | ml/100g/min | MEAN |
| PRIMARY | Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Placebo | 2 hours after placebo administration | 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. | ml/100g/min | MEAN |
| PRIMARY | Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Levetiracetam (LEV) | 2 hours after LEV administration | 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 percent signal change | MEAN |
| PRIMARY | Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Placebo | 2 hours after placebo administration | 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 percent signal change | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Levetiracetam (LEV) | Healthy Control Participants: Levetiracetam (LEV), Then Placebo | 28.3 | 95% Confidence Interval 25.2 to 31.3 | ml/100g/min | |
| Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Levetiracetam (LEV) | Healthy Control Participants: Placebo, Then Levetiracetam (LEV) | 27.1 | 95% Confidence Interval 24.9 to 29.4 | ml/100g/min | |
| Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Levetiracetam (LEV) | Patients With Schizophrenia: Levetiracetam (LEV), Then Placebo | 28.0 | 95% Confidence Interval 24.7 to 31.3 | ml/100g/min | |
| Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Levetiracetam (LEV) | Patients With Schizophrenia: Placebo, Then Levetiracetam (LEV) | 28.5 | 95% Confidence Interval 25.5 to 31.5 | ml/100g/min | |
| Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Placebo | Healthy Control Participants: Levetiracetam (LEV), Then Placebo | 28.1 | 95% Confidence Interval 25.6 to 30.5 | ml/100g/min | |
| Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Placebo | Healthy Control Participants: Placebo, Then Levetiracetam (LEV) | 28.3 | 95% Confidence Interval 25.2 to 31.4 | ml/100g/min | |
| Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Placebo | Patients With Schizophrenia: Levetiracetam (LEV), Then Placebo | 28.1 | 95% Confidence Interval 25.5 to 30.7 | ml/100g/min | |
| Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Placebo | Patients With Schizophrenia: Placebo, Then Levetiracetam (LEV) | 28.7 | 95% Confidence Interval 25.5 to 32.0 | ml/100g/min | |
| Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Levetiracetam (LEV) | Healthy Control Participants: Levetiracetam (LEV), Then Placebo | -0.0342 | 95% Confidence Interval -0.2172 to 0.1489 | BOLD percent signal change | |
| Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Levetiracetam (LEV) | Healthy Control Participants: Placebo, Then Levetiracetam (LEV) | 0.1216 | 95% Confidence Interval -0.0382 to 0.2813 | BOLD percent signal change |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (1 Day) | STARTED | Healthy Control Participants: Levetiracetam (LEV), Then Placebo | 15 | |
| First Intervention (1 Day) | STARTED | Healthy Control Participants: Placebo, Then Levetiracetam (LEV) | 15 | |
| First Intervention (1 Day) | STARTED | Patients With Schizophrenia: Levetiracetam (LEV), Then Placebo | 15 | |
| First Intervention (1 Day) | STARTED | Patients With Schizophrenia: Placebo, Then Levetiracetam (LEV) | 17 | |
| First Intervention (1 Day) | COMPLETED | Healthy Control Participants: Levetiracetam (LEV), Then Placebo | 15 | |
| First Intervention (1 Day) | COMPLETED | Healthy Control Participants: Placebo, Then Levetiracetam (LEV) | 15 | |
| First Intervention (1 Day) | COMPLETED | Patients With Schizophrenia: Levetiracetam (LEV), Then Placebo | 14 | |
| First Intervention (1 Day) | COMPLETED | Patients With Schizophrenia: Placebo, Then Levetiracetam (LEV) | 16 | |
| First Intervention (1 Day) | NOT COMPLETED | Healthy Control Participants: Levetiracetam (LEV), Then Placebo | 0 | |
| First Intervention (1 Day) | NOT COMPLETED | Healthy Control Participants: Placebo, Then Levetiracetam (LEV) | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting | Gastrointestinal disorders | Healthy Control Participants: Levetiracetam (LEV) | 0 | 30 | 0 |
| other | Vomiting | Gastrointestinal disorders | Healthy Control Participants: Placebo | 0 | 30 | 0 |
| other | Vomiting | Gastrointestinal disorders | Patients With Schizophrenia: Levetiracetam (LEV) | 0 | 31 | 0 |
| other | Vomiting | Gastrointestinal disorders | Patients With Schizophrenia: Placebo | 1 | 30 | 1 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Healthy Control Participants: Levetiracetam (LEV) | 0 | 30 |
| Total, all-cause mortality | Healthy Control Participants: Placebo | 0 | 30 |
| Total, all-cause mortality | Patients With Schizophrenia: Levetiracetam (LEV) | 0 | 31 |
| Total, all-cause mortality | Patients With Schizophrenia: Placebo | 0 | 30 |
| Total, other adverse events | Healthy Control Participants: Levetiracetam (LEV) | 0 | 30 |
| Total, other adverse events | Healthy Control Participants: Placebo | 0 | 30 |
| Total, other adverse events | Patients With Schizophrenia: Levetiracetam (LEV) | 0 | 31 |
| Total, other adverse events | Patients With Schizophrenia: Placebo | 1 | 30 |
| Total, serious adverse events | Healthy Control Participants: Levetiracetam (LEV) | 0 | 30 |
| Total, serious adverse events | Healthy Control Participants: Placebo | 0 | 30 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04559529
GET https://conductscience.org/api/trials/v1/NCT04559529/flow?page=2