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

(ADHD Trial)

Overseen By Kathryn Fotinos, M.Psy

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Dr. Martin A. Katzman

Must be taking: Long-acting psychostimulants

Must not be taking: Antipsychotics

Disqualifiers: Psychotic disorders, Seizure disorder, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether adding a small dose of cariprazine, a medication that affects brain chemicals, can help adults with ADHD who don't respond well to standard treatments. The goal is to see if this combination can better manage their symptoms. Cariprazine works by balancing chemicals in the brain that are important for attention and behavior.

Will I have to stop taking my current medications?

You can continue taking your current long-acting psychostimulant and any other stable psychotropic medications, except antipsychotics. If you are using recreational drugs, including cannabis, you must stop at least 2 weeks before joining the study.

What safety data exists for Cariprazine?

A study analyzed the safety of Cariprazine using real-world data from the FAERS database, which helps monitor adverse events (unwanted effects from taking a drug). This provides evidence for its safety surveillance in humans. ^{1 2 3 4 5}

How does the drug cariprazine differ from other treatments for schizophrenia and bipolar disorder?

Cariprazine is unique because it is a third-generation antipsychotic that acts as a partial agonist (activator) at dopamine D2 and D3 receptors, with a preference for D3, and also affects serotonin receptors. This mechanism may help address both positive and negative symptoms of schizophrenia, which are often challenging to treat, and it has shown efficacy in improving symptoms with generally mild to moderate side effects. ^{6 7 8 9 10}

Research Team

Martin A Katzman, MD

Principal Investigator

Clinic Director

Eligibility Criteria

Inclusion Criteria

The participant has provided signed informed consent.

Males and/or females aged 18-70 (extremes included).

Participants with a primary diagnosis of ADHD according to DSM-5 (314.01) criteria (diagnosis to be made using the Mini-International Neuropsychiatric Interview (MINI) 7.0.2 and confirmed by the Diagnostic Interview for ADHD in Adults (DIVA 5.0). Participants with a comorbid anxiety and depressive disorder will be permitted, as long as ADHD is judged to be the primary diagnosis.

Exclusion Criteria

You have experienced a mental health disorder other than the one being studied in the past six months.

If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study, or intending to donate ova during such time period.

You have started or stopped taking any medication recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive adjunct treatment with cariprazine alongside their stable dose of psychostimulants

8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Cariprazine

Participant Groups

Group I: Cariprazine treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Dr. Martin A. Katzman

Lead Sponsor

Trials

1

Recruited

20+

Findings from Research

A comprehensive analysis of the FAERS database revealed 3,659 adverse events (AEs) related to Cariprazine, highlighting significant safety concerns, particularly involving eye disorders that were not previously listed in the drug's official leaflet.

The study identified 140 different types of AEs across 27 organ systems, underscoring the importance of ongoing post-market surveillance to ensure healthcare professionals are aware of potential new adverse drug reactions (ADRs).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mining and analysis of adverse event signals of Cariprazine based on the real-world data of FAERS database. Zhu, H., Qu, Y., Du, Z., et al.[2023]

In a study involving 732 patients with erosive esophagitis, vonoprazan (VPZ) demonstrated high efficacy in healing the condition, achieving healing rates comparable to lansoprazole (LPZ) across all tested doses.

VPZ was found to be safe, with no significant safety concerns reported during the 8-week study, and a recommended effective dose of 20 mg once daily for treating severe erosive esophagitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised clinical trial: a dose-ranging study of vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the treatment of erosive oesophagitis. Ashida, K., Sakurai, Y., Nishimura, A., et al.[2018]

Cariprazine (Vraylar) is an atypical antipsychotic that acts as a partial agonist at dopamine D3 and D2 receptors, with a preference for D3, and also affects serotonin 5-HT1A receptors, which contributes to its therapeutic effects.

Approved in the USA in September 2015, cariprazine is used to treat schizophrenia and acute manic or mixed episodes in bipolar I disorder, and is being explored for additional uses in treating negative symptoms of schizophrenia and bipolar depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cariprazine: First Global Approval. McCormack, PL.[2018]

Cariprazine is a new medication approved by the FDA in 2015 for treating schizophrenia and type I bipolar disorder, showing efficacy in addressing positive, negative, and cognitive symptoms of schizophrenia without causing significant extrapyramidal side effects in animal models.

While cariprazine has a unique mechanism of action as a biased agonist at dopamine receptors, it can still cause mild to moderate side effects in humans, including akathisia, indicating the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cariprazine:New dopamine biased agonist for neuropsychiatric disorders. De Deurwaerdère, P.[2017]

In clinical trials, cariprazine significantly improved schizophrenia symptoms compared to placebo, as measured by the Positive and Negative Syndrome Scale (PANSS), and showed a longer time to relapse in a long-term study.

Cariprazine was more effective than risperidone in treating negative symptoms of schizophrenia, which are often challenging to address, and it was generally well tolerated with mostly mild to moderate side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cariprazine: A Review in Schizophrenia. Garnock-Jones, KP.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Mining and analysis of adverse event signals of Cariprazine based on the real-world data of FAERS database. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Vonoprazan: A New Potassium-Competitive Acid Blocker. [2023]

3. Japan pubmed.ncbi.nlm.nih.gov

Vonoprazan-based triple therapy is effective for Helicobacter pylori eradication irrespective of clarithromycin susceptibility. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Randomised clinical trial: a dose-ranging study of vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the treatment of erosive oesophagitis. [2018]

5. Australia pubmed.ncbi.nlm.nih.gov

Vonoprazan versus conventional proton pump inhibitor-based triple therapy as first-line treatment against Helicobacter pylori: A multicenter retrospective study in clinical practice. [2017]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Cariprazine: First Global Approval. [2018]

7. Spain pubmed.ncbi.nlm.nih.gov

Cariprazine:New dopamine biased agonist for neuropsychiatric disorders. [2017]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Cariprazine: A Review in Schizophrenia. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Cariprazine: chemistry, pharmacodynamics, pharmacokinetics, and metabolism, clinical efficacy, safety, and tolerability. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Case Report: Long-Acting Oral Cariprazine. [2023]