Open Label Extension Study of NCT06221852
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Virginie-Anne Chouinard, MD · PRINCIPAL_INVESTIGATOR · Mclean Hospital
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in brain redox nicotinamide adenine dinucleotide metabolites ratio (NAD+/NADH)24 weeks
Change from baseline to week 24 in NAD+/NADH as measured by in vivo phosphorus magnetic resonance spectroscopy (31P-MRS).
- Change in brain creatine kinase forward reaction rate (kf)24 weeks
Change from baseline to week 24 in creatine kinase forward reaction rate (kf) as measured by 31P magnetization transfer (MT) MRS.
- Change in insulin resistance24 weeks
Change from baseline to week 24 of insulin resistance measured using the homeostatic model assessment of insulin resistance (HOMA-IR) using fasting blood glucose and insulin levels.
- Change in psychotic symptoms24 weeks
Change from baseline to week 24 in Positive and Negative Syndrome Scale (PANSS) total score. Scores range from 30-210; a higher score indicates a higher level of psychotic symptoms.
- Change in depressive symptoms24 weeks
Change from baseline to week 24 in Hamilton Rating Scale for Depression (HAM-D) total score. Scores range from 0-52; a higher score indicates a higher level of depression.
- Change in mania symptoms24 weeks
Change from baseline to week 24 in Young Mania Rating Scale (YMRS) total score. Scores range from 0-60. A higher score indicates a more severe illness.
- Change in Clinical Global Impression (CGI) Scale24 weeks
Change from baseline to week 24 in Clinical Global Impression (CGI) Scale. Scores range from 1-7; a higher score indicates higher severity of illness.