Attention-Deficit/Hyperactivity Disorder Clinical Trial
Official title:
A Phase IV, Open-Label, Decentralized Clinical Trial to Evaluate the Efficacy and Safety of Qelbree® in Adults With Attention-Deficit/Hyperactivity Disorder and Mood Symptoms
Open label, flexible dose, decentralized clinical trial evaluating the efficacy and safety of SPN-812 in adults with ADHD and mood symptoms.
This is a Phase IV, open-label, flexible dose, decentralized clinical trial to evaluate the efficacy and safety of SPN-812 in adults with ADHD and mood symptoms. Adults 18 years and older with ADHD will be recruited, consented and screened for eligibility. Following the Screening Period (up to 4 weeks), eligible participants will be treated with Study medication for up to 14 weeks (Treatment Period). The total study duration is approximately 18 weeks, and there are up to 6 virtual study visits (or Televisits). All Televisits are conducted via an application downloaded to participant's mobile phone. There are up to 2 Televisits during the Screening period and 3 Televisits during the Treatment period. Subjects initiate SPN-812 dosing at 200 mg once daily during first week, and then titrate up to 400mg once daily during the second week. At the Investigator's discretion, based subject's clinical response and tolerability, the dose of SPN-812 can be increased or decreased to optimal dose within the range between 200 and 600 mg once daily during the remaining Treatment period. Participants will answer questions during structured clinical interviews with an investigator during Televisits and complete additional questionnaires and scales via the mobile app. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02251743 -
Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD
|
N/A | |
| Completed |
NCT02226445 -
Treatment Drop-out and Missed Appointments Among Adults With ADHD
|
N/A | |
| Completed |
NCT01342445 -
Effects of LDX on Functioning of College Students With ADHD
|
Phase 4 | |
| Not yet recruiting |
NCT00391495 -
Inflammation in Children With Attention-Deficit/Hyperactivity Disorder
|
N/A | |
| Completed |
NCT00528697 -
A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
|
Phase 2 | |
| Completed |
NCT00494819 -
Validity of ADHD Subtypes Using Neuropsychological Measure
|
N/A | |
| Completed |
NCT02217371 -
Role of Circadian and Homeostatic Systems in the Regulation of Wakefulness in Adult Patients With Attention Deficit Disorder With or Without Hyperactivity
|
N/A | |
| Completed |
NCT01081132 -
Dose-optimization in Adolescents Aged 13-17 Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD) Using Extended-release Guanfacine HCl
|
Phase 3 | |
| Completed |
NCT06064942 -
Multiple Family Narrative Therapy for Chinese Families of Children With Attention Deficit Hyperactivity Disorder
|
N/A | |
| Completed |
NCT00391729 -
A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
|
Phase 2 | |
| Completed |
NCT00191048 -
Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHD
|
Phase 4 | |
| Terminated |
NCT00554385 -
A Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
|
Phase 2 | |
| Completed |
NCT00997984 -
Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)
|
Phase 3 | |
| Not yet recruiting |
NCT05568446 -
Social VR Based Intervention on Enhancing Social Interaction Skills in Children With AD/HD
|
N/A | |
| Completed |
NCT02096952 -
Methylphenidate ER Liquid Formulation in Adults With ASD and ADHD
|
Phase 4 | |
| Recruiting |
NCT02623114 -
Attention-deficit/Hyperactivity Disorder Translational Center for Identifying Biomarkers
|
Phase 4 | |
| Completed |
NCT01351246 -
Guided Self-Help for Parents of Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
|
N/A | |
| Completed |
NCT00686933 -
Long Term Safety and Tolerability Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
|
Phase 2 | |
| Completed |
NCT00491647 -
Time Perception Deficits and Attention-Deficit/Hyperactivity Disorder
|
N/A | |
| Completed |
NCT01081145 -
Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
|
Phase 3 |