权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

Dopamine-2 Receptor Partial Agonist for Bipolar Disorder and Alcohol Use Disorder

多巴胺 2 受体部分激动剂治疗双相情感障碍和酒精使用障碍

基本信息

批准号：
9175896
负责人：
E SHERWOOD BROWN
金额：
$ 54.33万
依托单位：
UT SOUTHWESTERN MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-15 至 2021-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9175896
关键词：
Acute Adverse effects Agonist Alanine Transaminase Alcohol consumption Alcohol-Related Disorders Alcohols Algorithms Anti-Inflammatory Agents Anti-inflammatory Antidepressive Agents Antipsychotic Agents Aspartate Transaminase Benefits and Risks Biological Markers Bipolar Disorder Bipolar I Bipolar II Blood Glucose Blood specimen C-reactive protein Clinical Clinical Trials Conduct Clinical Trials DRD4 gene Data Depressed mood Development Disease Dopamine Dose Double-Blind Method Enzymes FDA approved Gamma-glutamyl transferase Genetic Polymorphism Genotype Geographic Locations Hamilton Rating Scale for Depression Heavy Drinking Hospitalization Impulsivity Inflammation Inflammatory Laboratories Literature Liver Manic Mental Depression Mental disorders Methods Modeling Monitor Mood Disorders Mood stabilizers Moods Morbidity - disease rate Naltrexone Outcome Outcome Measure Outpatients Participant Patient Self-Report Patients Persons Pharmaceutical Preparations Phase Placebos Population Prevalence Public Health Publishing Randomized Research Research Design Role Safety Sampling Serum Substance Use Disorder Symptoms TimeLine Titrations Violence abstracting adverse outcome alcohol craving alcohol research alcohol use disorder aripiprazole atypical antipsychotic base blood lipid carbohydrate-deficient transferrin control trial depressive symptoms design disability double-blind placebo controlled trial drinking dual diagnosis effective therapy experience inclusion criteria inventory of depressive symptomatology mood symptom placebo controlled study predicting response primary outcome quetiapine receptor response secondary outcome statistics

项目摘要

Abstract Bipolar disorder is a severe, persistent, and common psychiatric illness that is associated with a staggering 46% lifetime prevalence of alcohol-related disorders. Alcohol use disorder in patients with bipolar disorder is associated with numerous adverse consequences including increased hospitalization, poor outcome during hospitalization, violence towards self and others, and treatment nonadherence. Thus, the development of effective treatments for patients with bipolar and alcohol use disorder is a major public health concern. However, to date, few placebo-controlled trials have been conducted in patients with bipolar disorder and alcohol use disorder. Our group conducts clinical trials in persons with bipolar disorder and substance use disorders. A particularly promising medication that we have investigated is the atypical antipsychotic aripiprazole. A 12-week, randomized, double-blind, placebo-controlled study of aripiprazole is proposed in 132 outpatients with bipolar I or II disorder (depressed or mixed mood state) and alcohol use disorder, with active alcohol use. Alcohol use will be the primary outcome, with alcohol craving and mood symptoms as secondary outcomes. To reflect the diversity of our geographic region, both English- and Spanish-speaking participants will be included. The study design includes a 12-week acute phase with a maximum aripiprazole dose of 15 mg/day. A 4-week extension phase for completers with at least one heavy drinking day at week 12 will explore an aripiprazole titration up to 30 mg/day. To standardize management of other psychotropic medications (e.g. mood stabilizers, antidepressants), concomitant medication changes will be managed in both groups using a treatment algorithm. Relationships between changes in alcohol use and changes in mood will be explored. Outcome measures will include alcohol use assessed with the Timeline Followback method, Hamilton Rating Scale for Depression, Inventory of Depressive Symptomatology–Self-report, Young Mania Rating Scale, Penn Alcohol Craving Scale, as well as liver enzyme and carbohydrate deficient transferrin levels. Side effects, including those associated with antipsychotics, will be monitored. Additionally, blood samples will be obtained for genotype analysis, as well as laboratory values including blood sugar and lipid levels. A research team with extensive experience in dual diagnosis, mood disorders, clinical trials, statistics, and alcohol research will conduct the trial.

摘要