Feasibility and Limited Efficacy Trial of a Cognitive Behavioral Intervention to Reduce Procedural Anxiety Among Woman with High Risk Pregnancies with Scheduled Cesarean DeliveriesProtocol #: 19-1896 Location: Childrens Hospital Colorado |
Neurocognitive Targets of Hostile Interpretation Bias Training to Treat IrritabilityThis trial lays the foundation for a preliminary test of efficacy of IBT on irritability by establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system. The design will test whether active relative to sham IBT shifts the indifference point towards more benign judgments. Neural response to active versus sham IBT will be measured in half the sample. Hostile interpretation bias may be a feature of severe, chronic irritability in children, one of the most common psychiatric symptoms of childhood. Interpretation bias training (IBT) is a computer-based training program that may reduce irritability in youths. This trial lays the groundwork for a test IBT on irritability. This trial lays the foundation for a preliminary test of efficacy of IBT on irritability by establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system. The design is a single-blinded, randomized controlled trial of IBT on its targets. The study will have four arms, with 25 participants in each arm for all four conditions of training (active versus sham) and scanning (in MRI or out of MRI scanner). During IBT, participants judge as happy or angry facial expressions which are on a continuum between happy and angry. The point at which judgments shift from predominantly happy to angry on this continuum is the indifference point. During training feedback encourages no change in the indifference point or a change in the indifference point towards more happy judgments of ambiguous faces. A shift in indifference point towards more benign judgments is interpreted as a reduction in hostile interpretation. The design will test whether active relative to sham IBT shifts the indifference point towards more benign judgments. Neural response to active versus sham IBT will be measured in half the sample. Protocol #: 17-0464 Location: Childrens Hospital Colorado |
A pharmacogenetic human laboratory investigation of brexpiprazole in Alcohol Use DisorderFew medications are currently Food & Drug Administration (FDA)-approved for the treatment of Alcohol Use Disorder (AUD), and those that are have, on average, modest effects on drinking. Precision medicine research has explored whether patient-level variables, such as genetic variation, may identify subgroups of individuals with larger medication effects, but few findings have been replicated. A promising novel medication for AUD is brexpiprazole (BREX), a serotonin/dopamine activity modulator (SDAM). This study will evaluate the effects of two doses of BREX, relative to placebo, among non-treatment-seeking individuals with AUD, and will test whether DAT1 genotype influences these effects. Functional magnetic resonance imaging (fMRI) will be used to explore whether BREX effects on brain activation associated with cognitive control or elicited by alcohol cues accounts for its effects on drinking. If the study hypotheses are supported, BREX may represent a novel pharmacogenetic treatment for AUD. The overarching hypothesis of this proposal is that brexpiprazole (BREX) (2 or 4 mg/day), relative to placebo, will reduce alcohol consumption and modulate the neural substrates of moderate-severe Alcohol Use Disorder (AUD), and that genotype at a variable number tandem repeat polymorphism (VNTR) in the DAT1/SLC6A3 gene will predict BREX effects. Participants will be non-treatment-seeking Alcohol Use Disorder individuals, and will be prospectively randomized to medication on the basis of their DAT1 VNTR genotype. Since BREX affects both cortical and striatal neurophysiology, we will use functional magnetic resonance imaging (fMRI) to test its effects on cortical (right inferior frontal gyrus; rIFG) activation associated with response inhibition and on striatal activation elicited by alcohol cues, and will explore whether either of these measures mediates BREX effects on drinking in the natural environment vs. a bar-lab setting, which may reflect different aspects of lost control over drinking. Protocol #: 19-1658 Locations: Department Specific Free Standing Clinic; University of Colorado Hospital |
My Transgender Brain Study (MyT "Mighty" Brain) - ColoradoProtocol #: 18-1740 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital |
Effects of low-dose levetiracetam on clinical symptoms, cognition and hippocampal hyperactivity in patients with schizophreniaProtocol #: 13-1495 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital |
Double-blind Trial of Phosphatidylcholine Supplementation during Pregnancy: Impact on Attention and Social Withdrawal at 4 years of AgePrimary Objective: Assess whether parental rating of problems on the Attention and Social Withdrawal indices of the Child Behavior Checklist at 4 years of age for children of mothers who received prenatal phosphatidylcholine supplementation are lower, compared to children whose mothers received placebo. Protocol #: 16-1510 Locations: Colorado Research Center; Denver Health Medical Center; Department Specific Free Standing Clinic; University of Colorado Hospital |