drugset / Trial / NCT04843423

Adjunct Treatment With Cariprazine for Adults With Attention-deficit/Hyperactivity Disorder

NCT04843423

Phase 4 Unknown 15 enrolled Dr. Martin A. Katzman
NaSingle-groupOpen-labelTreatment

Summary

According to the Canadian ADHD Practice Guidelines, psychostimulants are the preferred treatment of attention-deficit/hyperactivity disorder (ADHD), especially for those that require urgent care. Specifically, long-acting psychostimulants are considered the gold-standard pharmacological treatment for ADHD. Using extended-release formulations, long-acting psychostimulants provide an extended duration of daily symptom relief in addition to overall reductions in ADHD symptoms that are maintained over time. In accordance with these guidelines, clinicians may combine psychostimulants with other medications when it is considered necessary. For complex cases, psychostimulants alone are often inadequate for improving the effects of ADHD and are therefore prescribed in conjunction with other medications. At low doses, antipsychotics have been considered appropriate adjunctive medications. Studies show that most adult cases with ADHD that were undiagnosed or untreated in childhood result in the need for adjunctive medication in adulthood to enhance the effects of the psychostimulant. As a result, it is hypothesized that adjunct treatment with a low dose of cariprazine, an atypical antipsychotic, will enhance the effectiveness of standard ADHD treatment with a long-acting psychostimulant in a subset of the ADHD population that achieved little to no response on psychostimulants alone.

Timeline

Start
2021-12-01
Primary completion
2022-12-30
Completion
2023-04-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Cariprazine Small molecule 1.5 mg Oral
Subject Cariprazine Small molecule 3 mg Oral