Bipolar Disorder Clinical Trial
— Long_BACSOfficial title:
Biological Risk Factors for the Prospective Development of Alcohol Use Disorders in Young Adults With Bipolar Disorder and Typically Developing Young Adults
Alcohol use disorders (AUDs) affect up to 60% of individuals with bipolar disorder during their lifetime and is associated with worse illness outcomes, yet few studies have been performed to clarify the causes of this comorbidity. Understanding biological risk factors that associate with and predict the development of AUDs in bipolar disorder could inform interventions and prevention efforts to reduce the rate of this comorbidity and improve outcomes of both disorders. Identifying predictors of risk requires longitudinal studies in bipolar disorder aimed at capturing the mechanisms leading to the emergence of AUDs. Previous work in AUDs suggest that subjective responses to alcohol and stress-related mechanisms may contribute to the development of AUDs. In bipolar disorder, altered developmental trajectory of critical ventral prefrontal networks that modulate mood and reward processing may alter responses to alcohol and stressors; consequently, the disruption in typical neurodevelopment may be an underlying factor for the high rates of comorbidity. No longitudinal data exist investigating if this developmental hypothesis is correct. To address this gap, the investigators will use a multimodal neuroimaging approach, modeling structural and functional neural trajectories of corticolimbic networks over young adulthood, incorporating alcohol administration procedures, clinical phenotyping, and investigating effects of acute stress exposure and early life stress. Research aims are to identify biological risk factors-i.e., changes in subjective response to alcohol and associated neural trajectories-that are associated with the development of alcohol misuse and symptoms of AUDs over a two-year longitudinal period in young adults with bipolar disorder and typical developing young adults. Longitudinal data will be collected on 160 young adults (50% with bipolar disorder, 50% female; aged 21-26). This study is a natural extension of the PI's K01 award. How acute exposure to stress and childhood maltreatment affects subjective response to alcohol and risk for prospective alcohol misuse and symptoms of AUDs will be investigated. The investigators will test our hypothesis that developmental differences in bipolar disorder versus typical developing individuals disrupt corticolimbic networks during young adulthood, increase sensitivity to stress, and lead to changes in subjective response to alcohol and placebo response increasing risk for developing AUDs.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 31, 2028 |
Est. primary completion date | March 31, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 26 Years |
Eligibility | Inclusion Criteria: Inclusion criteria for all participants: - between 21 and 26 years of age - having consumed at least 4 (men) or 3 (women) drinks on a single occasion over the last year - euthymic at the time of enrollment Inclusion criteria for bipolar disorder participants: - Meeting Diagnostic and Statistical Manual-5 Research Version (DSM-V-RV) diagnostic criteria for bipolar disorder, confirmed by structured interview Exclusion Criteria: For all subjects exclusion criteria include: - history of significant medical illness, particularly if possible changes in cerebral tissue - neurologic abnormality including significant head trauma (loss of consciousness of =5-min) - full Scale intelligence quotient (IQ) <85 - contraindication to MRI scanning - positive pregnancy test - current cannabis use disorder>moderate - history of severe AUDs - scores > 15 on the alcohol Use Disorders Identification Test (AUDIT; part of phone screen) - ever being in an abstinence-oriented treatment program for alcohol use - reporting wanting to quit drinking but not being able to - any medical, religious, or other reasons for not drinking alcohol - history of heart attack, heart trouble, high blood pressure, diabetes, or liver disease - an adverse reaction to alcoholic beverages - reporting never consuming 4 (men) or 3 (women) or more drinks on a single occasion over the last year - unwillingness to have a friend or family member drive them home after the alcohol administration sessions - a past year substance use disorder (other than alcohol, cannabis, or nicotine) Additional exclusion criteria for bipolar disorder participants: - not taking medications for greater than or equal to 4 weeks (i.e. participants must be stable on medications) Additional exclusion criteria for healthy comparison subjects also include: - any prior psychiatric hospitalizations - lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, eating disorder - greater than 1 month of lifetime psychotropic medication. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas at Austin | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas at Austin |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes in subjective response | Subjective response to alcohol will be measured with the subjective effects of alcohol scale (SEAS) at baseline and two-years later and changes in subjective response to alcohol over time (SEAS two year follow-up minus SEAS baseline) investigated and interactions with group (young adults with bipolar disorder, typical comparison young adults) modeled. | 2 years | |
Primary | Neural trajectories associated with subjective response to alcohol | Changes in neural trajectories over the two-year follow-up period will be modeled and relations with subjective response at two-year follow-up investigated. We will model changes in cortical thickness and surface area of frontolimbic regions of interest and investigate if these neural trajectories relate to changes in subjective response to alcohol (measured with the SEAS at baseline and follow-up). | 2 years | |
Primary | Relations between changes in subjective response and associated neural trajectories with alcohol use disorder symptoms at two-year follow-up | Changes in subjective response (measured with the SEAS) and neural trajectories over the follow up period (changes in cortical thickness and surface area of frontlimbic regions of interest) and relations with alcohol problems at two-year follow up will be modeled with number of alcohol use disorder symptoms on the SCID at two-year follow up as the dependent variable. | 2 years | |
Primary | Relations between changes in subjective response and associated neural trajectories with alcohol misuse and problems at two-year follow-up | Changes in subjective response (measured with the SEAS) and neural trajectories over the follow up period (changes in cortical thickness and surface area of frontolimbic regions of interest) and relations with alcohol problems at two-year follow up will be modeled with AUDIT score at two-year follow up as the dependent variable. | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT02855762 -
Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder
|
N/A | |
Recruiting |
NCT05915013 -
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
|
Phase 1 | |
Recruiting |
NCT05206747 -
Ottawa Sunglasses at Night for Mania Study
|
N/A | |
Completed |
NCT02513654 -
Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects
|
Phase 1 | |
Recruiting |
NCT06313918 -
Exercise Therapy in Mental Disorders-study
|
N/A | |
Completed |
NCT02304432 -
Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine
|
Early Phase 1 | |
Recruiting |
NCT06197048 -
Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder
|
N/A | |
Completed |
NCT03497663 -
VIA Family - Family Based Early Intervention Versus Treatment as Usual
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Completed |
NCT02212041 -
Electronic Cigarettes in Smokers With Mental Illness
|
N/A | |
Recruiting |
NCT05030272 -
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
|
N/A | |
Recruiting |
NCT04298450 -
ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention
|
N/A | |
Active, not recruiting |
NCT03641300 -
Efficacy of Convulsive Therapies for Bipolar Depression
|
N/A | |
Not yet recruiting |
NCT04432116 -
Time and Virtual Reality in Schizophrenia and Bipolar Disorder
|
N/A | |
Terminated |
NCT02893371 -
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
|
||
Terminated |
NCT02909504 -
Gao NARASD Lithium Study
|
Phase 4 | |
Completed |
NCT02970721 -
Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
|
||
Recruiting |
NCT02481245 -
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
|
Phase 2 | |
Recruiting |
NCT03088657 -
Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
|