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

Sponsor
Dr. Martin A. Katzman
Study ID
NCT04843423
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cariprazine — DRUG
    At the screening visit, those who are eligible will enter an open-label trial with cariprazine in doses ranging from 1.5mg to 3 mg. The study will begin with a single week of cariprazine 1.5 mg oral tablets. After the first week the participants' dosage may be increased up to a maximum of 3 mg daily. This dose will remain fixed after 4 weeks of treatment until week 8, at which time the medication will be discontinued. Because the drug is not yet available to market in Canada, participants will be dispensed the drug in appropriately labelled 7-day tablet containers with the appropriate dose, including 3 additional tablets to account for scheduling conflicts. Participants will be instructed to return the tablet containers at each Study Visit in order to assess drug compliance. They will then be newly dispensed the appropriate quantity according to their next scheduled study visit.

Study Details

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.

Key Dates

Start date
Dec 1, 2021
Status verified
Dec 2021
Primary completion
Dec 30, 2022
Completion
Apr 14, 2023

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cariprazine treatment

Primary Outcome Measure

Mean changes in the ADHD Rating Scale (ADHD RS-5) [ Time Frame: Pre treatment (screening, week 0) and post treatment (week 8) ]

Central Contacts

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