MedTrace Logo

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

NCT04843423 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-12-14

No results posted yet for this study

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.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

Cariprazine

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.

Sponsors & Collaborators

  • Dr. Martin A. Katzman

    lead OTHER

Principal Investigators

  • Martin A Katzman, MD · Clinic Director

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-12-30
Completion
2023-04-14
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04843423 on ClinicalTrials.gov