Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
A Phase 3, Dose-Optimized, Randomized, Double-Blind, Placebo-Controlled, Single-Center, Parallel Efficacy and Safety Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)
The goal of this clinical trial is to evaluate the efficacy and safety of CTx-1301 in adults with ADHD in a laboratory classroom setting.
A single-center, dose-optimized, double-blind, randomized, placebo-controlled, parallel efficacy and safety laboratory classroom study with CTx-1301 in approximately 25 adults aged 18 to 55 years with ADHD. The study will be comprised of a screening period, a dose-optimization phase, a double-blind randomized phase, and a safety follow-up phase. Subjects will undergo a screening visit prior to entering a 5-week dose-optimization phase. During the dose-optimization phase subjects will have weekly visit and will be titrated to doses ranging between 25mg-50mg of CTx-1301. Eligible subjects will be randomized to their optimal dose or placebo in a 1:1 ratio after completing a practice Adult Laboratory Classroom (ALC) visit with 4 PERMP assessments. Subjects will take their assigned/randomized dose over the following 7-day period. On the 7th day subjects will complete a full ALC visit. The duration of the full ALC visit will be approximately 17 hours. Subjects will have an in-clinic safety follow-up visit within 7 days after the full adult laboratory classroom visit. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06129396 -
Effects of Aerobic Exercise Intervention in Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
|
N/A | |
| Completed |
NCT04779333 -
Lifestyle Enhancement for ADHD Program 2
|
N/A | |
| Recruiting |
NCT05935722 -
Evaluation of a Home-based Parenting Support Program: Parenting Young Children
|
N/A | |
| Completed |
NCT03148782 -
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase
|
N/A | |
| Completed |
NCT04832737 -
Strength-based Treatment Approach for Adults With ADHD
|
N/A | |
| Recruiting |
NCT04631042 -
Developing Brain, Impulsivity and Compulsivity
|
||
| Recruiting |
NCT05048043 -
Development of a Game-supported Intervention
|
N/A | |
| Completed |
NCT03337646 -
Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism
|
Phase 4 | |
| Not yet recruiting |
NCT06406309 -
Settling Down for Sleep in ADHD: The Impact of Sensory and Arousal Systems on Sleep in ADHD
|
N/A | |
| Not yet recruiting |
NCT06454604 -
Virtual Reality Treatment for Emerging Adults With ADHD
|
Phase 2 | |
| Not yet recruiting |
NCT06080373 -
Formulation-based CBT for Adult Inmates With ADHD: A Randomized Controlled Trial
|
N/A | |
| Completed |
NCT02477280 -
Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance
|
Phase 4 | |
| Completed |
NCT02911194 -
a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD)
|
N/A | |
| Completed |
NCT02780102 -
Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD
|
N/A | |
| Completed |
NCT02829970 -
Helping College Students With ADHD Lead Healthier Lifestyles
|
N/A | |
| Completed |
NCT02555150 -
A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD
|
Phase 3 | |
| Completed |
NCT02390791 -
New Technologies to Help Manage ADHD
|
N/A | |
| Completed |
NCT02473185 -
Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance During the QbTest
|
Phase 4 | |
| Recruiting |
NCT04296604 -
Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
|
N/A | |
| Recruiting |
NCT04175028 -
Neuromodulation of Executive Function in the ADHD Brain
|
N/A |