Open Label Extension Study of NCT06221852
Not Applicable
- Conditions
- Bipolar I DisorderSchizoaffective DisorderPsychosis
- Registration Number
- NCT06558201
- Lead Sponsor
- Mclean Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion Criteria:<br><br> - Participants who met original entry criteria in, and completed, the randomized<br> 12-week study of NCT06221852.<br><br>Exclusion Criteria:<br><br>-No longer meeting original entry criteria from the randomized 12-week study of<br>NCT06221852.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in brain redox nicotinamide adenine dinucleotide metabolites ratio (NAD+/NADH);Change in brain creatine kinase forward reaction rate (kf);Change in insulin resistance;Change in psychotic symptoms;Change in depressive symptoms;Change in mania symptoms;Change in Clinical Global Impression (CGI) Scale
- Secondary Outcome Measures
Name Time Method Change in body weight;Change in glycated hemoglobin (Hemoglobin A1c) level;Change in triglyceride levels;Change in low-density lipoprotein (LDL) levels;Change in high-density lipoprotein (HDL) levels;Change in high-sensitivity C-reactive protein (hs-CRP) levels;Change in brain gamma-aminobutyric acid (GABA) concentration;Change in brain glutamate metabolite concentration;Change in brain glutathione (GSH);Change in brain Phosphocreatine (PCr);Change in brain pH;Change in brain inorganic phosphate concentration;Change in adverse events;Change in anxiety symptoms;Change in stress symptoms;Change in cognitive performance;Change in Global Functioning Scale (GFS) - Social and Role total score;Change in blood NAD/NADH+ ratio;Change in blood GSH/GSSH ratio;Change in growth differentiation factor 15 (GDF15);Change in cell-free mitochondrial DNA (cf-mtDNA)