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| Name | Class |
|---|---|
| Laureate Institute for Brain Research, Inc. | OTHER |
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This is a single site, randomized, double-blind, placebo-controlled, within-subjects study design in healthy volunteers. Escalating single doses of ITI-214 will be evaluated using functional magnetic resonance imaging (fMRI) to determine central nervous system engagement. Safety and tolerability also will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 mg ITI-214 | Experimental | Single dose |
|
| 10 mg ITI-214 | Experimental | Single dose |
|
| Placebo | Placebo Comparator | Single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITI-214 | Drug | Oral |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| BOLD MRI signals in the anterior insula during the extinction phase of a Fear Conditioning task | Changes in brain activation | 1-3 hours post-dose |
| BOLD MRI signals in the inferior frontal gyrus during the Stop Signal Task | Changes in brain activation | 1-3 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| BOLD fMRI signals elicited by fear conditioning stimulus | Changes in brain activation in amygdala, prefrontal cortex, and/or insula cortex | 1-3 hours post-dose |
| BOLD fMRI signals elicited by the Stop versus Go signal |
| Measure | Description | Time Frame |
|---|---|---|
| BOLD fMRI signals elicited in the amygdala, insula and medial prefrontal cortex | Pharmacodynamics | 1-3 hours post-dose |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Davis, PhD | Intra-Cellular Therapies, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laureate Institute for Brain Research, Inc. | Tulsa | Oklahoma | 74136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35488084 | Derived | Khalsa SS, Victor TA, Kuplicki R, Yeh HW, Vanover KE, Paulus MP, Davis RE. Single doses of a highly selective inhibitor of phosphodiesterase 1 (lenrispodun) in healthy volunteers: a randomized pharmaco-fMRI clinical trial. Neuropsychopharmacology. 2022 Sep;47(10):1844-1853. doi: 10.1038/s41386-022-01331-3. Epub 2022 Apr 29. |
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| ID | Term |
|---|---|
| C000625407 | ITI-214 |
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| Drug |
Oral |
|
Changes in brain activation in dorsolateral prefrontal cortex and/or anterior cingulate cortex
| 1-3 hours post-dose |
| Number of subjects with reported or observed treatment-related adverse events | Safety and tolerability | 0-5 hours post-dose |