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The purpose of this study is to evaluate the effects of TS-134 on ketamine-induced BOLD signals in ROIs in resting fMRI in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TS-134 20 mg | Experimental |
| |
| TS-134 60 mg | Experimental |
| |
| Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-134 | Drug | Multiple dose titrations from 10 mg to 20 mg once daily for 6 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| BOLD fMRI signals in pre-specified ROIs | Changes in ketamine-induced BOLD fMRI signals in pre-specified ROIs (anterior cingulate cortex (ACC) and anterior insula) following administrations of TS-134 | Screening and Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| BOLD fMRI signals in whole brain | Changes in ketamine-induced BOLD fMRI signals in whole brain following administrations of TS-134 | Screening and Day 6 |
| Brief Psychiatric Rating Scale (BPRS) | Changes in BPRS scores following administrations of TS-134 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey A Lieberman, MD | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| TS-134 |
| Drug |
Multiple dose titrations from 10 mg to 60 mg once daily for 6 days |
|
| Placebo | Drug | Multiple doses of placebo once daily for 6 days |
|
| Ketamine | Other | 0.23 mg/kg bolus over one minute on Screening (baseline) and Day 6 |
|
| Screening and Day 6 |
| Clinician Administered Dissociative State Scale (CADSS) | Changes in CADSS scores following administrations of TS-134 | Screening and Day 6 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |