Glutamatergic Mechanisms of Psychosis and Target Engagement: Aim2
New York State Psychiatric Institute
Summary
In the present study, 120 healthy volunteers (HV) will be randomized to one of three ketamine-induced pharmacoBOLD (phBOLD) arms: low, medium, and high. Within each ketamine arm, participants will be randomized to 4 days of "study drug" \[TS-134 (1st 20 participants) or XT (remaining 100 participants)\] or placebo in a 5:3 ratio (25 study drug:15 placebo per arm). During the study, each participant will undergo a Screening Period (up to 31 days), a 4-day Treatment Period, and a total of two phBOLD sessions: a first session at Baseline and a second session on Day 4 of the Treatment Period, conducted at least 7 days apart, and a follow up visit.
Description
Schizophrenia (Sz) is associated with psychotic symptoms, such as hearing voices and paranoid beliefs that remain partially or fully refractory to standard antipsychotic medications for \~2/3 of patients. Alternative, glutamatergic approaches for treatment development have been proposed but have not yet led to FDA-approved medications. Moreover, several glutamate-targeted medications, such as pomaglumetad (POMA), have failed in pivotal clinical trials despite robust effectiveness in preclinical models. A major barrier to effective glutamatergic treatment development is the absence of validated…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Age between 18-55 at screen 2. Medically healthy, as assessed by study physician at screen 3. Capable of understanding the study procedures and able to provide informed consent 4. Eligible men and women must agree to use a reliable method of birth control (See section 5.3) during the study. Women who are post-menopausal or otherwise not of childbearing potential are also eligible. 5. Willing and reliable to participate in XT or placebo phase as an outpatient and/or agreeable to participate as an inpatient. Exclusion Criteria: 1. Current or past Axis I psychiatric hist…
Interventions
- DrugKetamine
Ketamine during an MRI
- DrugTs-134
4 days of TS-134 20 mg
- DrugPlacebo
4 days of placebo TS-134
Location
- NYSPINew York, New York