Bipolar Disorder Clinical Trial
ADHD in the adult population is associated with several measures of harmful dysfunction. For
example, adult ADHD is associated with high rates of separation/divorce and never-married
status, lower educational attainment and occupational achievement, absenteeism,
presenteeism, and job termination, as well as decreased social function. Individuals with
adult ADHD are more likely than controls to have a comorbid diagnosis of bipolar disorder,
alcohol and substance abuse, as well as antisocial personality disorder.
Psychostimulants are the most frequently employed medications in the treatment of adult
ADHD. Several psychostimulants are Health Canada and US FDA-approved for the treatment of
ADHD symptoms in adulthood.
Hitherto, no trial has evaluated the safety and efficacy of a psychostimulant in the
treatment of ADHD symptomatology in adult individuals with bipolar disorder.
Vyvanse is the first prodrug stimulant indicated for the treatment of adult (and pediatric)
ADHD. Vyvanse is a therapeutically inactive molecule (i.e. prodrug). After oral ingestion,
lisdexamfetamine is converted to l-lysine, a naturally occurring essential amino acid, and
active d-amphetamine, which is responsible for the drug's activity. Vyvanse provides a
longer duration of effect consistent throughout the day with reduced potential for risk of
abuse. Vyvanse is generally well tolerated with an adverse event profile similar to other
psychostimulant medications. Available evidence indicates that in most treated subjects,
Vyvanse is weight-neutral and/or is associated with weight loss. Moreover, in some
individuals, it is associated with improvement in both glucose and lipid homeostasis.
The evaluation of safety/tolerability profiles as well as the effectiveness of
lisdexamfetamine in a "real-world" population has significant translational value.
n/a
Time Perspective: Prospective
| 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 | |
| Completed |
NCT02970721 -
Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
|
||
| Terminated |
NCT02909504 -
Gao NARASD Lithium Study
|
Phase 4 | |
| Terminated |
NCT02893371 -
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
|
||
| Recruiting |
NCT03088657 -
Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
|
||
| Recruiting |
NCT02481245 -
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
|
Phase 2 |