Phase 4
N=10
The Effects of Antipsychotic Drugs on Brain Metabolism in Healthy Individuals
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02536846 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Change in Brain Nicotinamide Adenine Dinucleotide Metabolites NAD+/NADH — -0.79 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Olanzapine (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Dost Ongur
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Brain Nicotinamide Adenine Dinucleotide Metabolites NAD+/NADH |
-0.79 | — |
| PRIMARY Change in Brain Phosphocreatine (PCr) |
0.01 | — |
| PRIMARY Change in Brain Creatine Kinase (CK) Forward Reaction Rate |
-0.04 | — |
| PRIMARY Change in Brain Parenchymal pH |
0.00 | — |
| SECONDARY Change in Volumes of the Frontal, Parietal and Temporal Lobe Regions |
-2500.44; -600 | — |
| SECONDARY Change in Surface Area of the Frontal, Parietal and Temporal Regions |
-801.19; -581.56 | — |
| SECONDARY Change in fMRI Resting State Functional Connectivity |
0; 0 | — |
| SECONDARY Change in GABA Concentration |
0.11 | — |
| SECONDARY Change in Fractional Anisotropy (FA) Measured by Diffusion Tensor Imaging (DTI) |
0.0007; -0.003; -0.008; -0.002; 0.002 | — |
| SECONDARY Change in Glutamate Metabolite Concentration |
0.13 | — |
| SECONDARY Change in MATRICS Cognitive Consensus Battery (MCCB) Total Composite Score |
3.63 | — |
Summary
The primary aim of this study is to investigate antipsychotic drug effects on healthy brain metabolism.
Eligibility Criteria
Inclusion Criteria
- Age: 21-50 years old
- Male or female
- Without psychiatric diagnosis according to a structured psychiatric interview (SCID)
- Without history of a psychotic disorder among parents, siblings, or children
Exclusion Criteria
- Significant medical or neurological illness
- Diagnosis diabetes mellitus, uncontrolled hypertension, severe hypotension, coronary artery disease, metabolic syndrome, glaucoma, liver impairment, decreased renal function, respiratory disorders, peptic ulcer disease (absolute and relative contraindications to use of antipsychotic drugs)
- Body mass index (BMI) over 30
- Taking any other medications, including over the counter supplements with the exception of oral contraceptives for women
- Pregnancy. Females of child-bearing age must be using an effective contraceptive method
- History of smoking, substance abuse or dependence
- Contraindication to MR scan (claustrophobia, cardiac pacemakers, metal clips and stents on blood vessels, artificial heart valves, artificial arms, hands, legs, etc., brain stimulator devices, implanted drug pumps, ear implants, eye implants or known metal fragments in eyes, exposure to shrapnel or metal filings, other metallic surgical hardware in vital areas, certain tattoos with metallic ink, certain transdermal patches, metal-containing IUDs)
- Medical condition that would prevent blood draws
Data sourced from ClinicalTrials.gov (NCT02536846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.