15 Participants Needed

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

(ADHD Trial)

SL
KF
Overseen ByKathryn Fotinos, M.Psy
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Dr. Martin A. Katzman
Must be taking: Long-acting psychostimulants
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

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.12345

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.678910

Research Team

MA

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.
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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.
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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
1Treatment groups
Experimental Treatment
Group I: Cariprazine treatmentExperimental Treatment1 Intervention

Find a Clinic Near You

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

References

Mining and analysis of adverse event signals of Cariprazine based on the real-world data of FAERS database. [2023]
Vonoprazan: A New Potassium-Competitive Acid Blocker. [2023]
Vonoprazan-based triple therapy is effective for Helicobacter pylori eradication irrespective of clarithromycin susceptibility. [2022]
Randomised clinical trial: a dose-ranging study of vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the treatment of erosive oesophagitis. [2018]
Vonoprazan versus conventional proton pump inhibitor-based triple therapy as first-line treatment against Helicobacter pylori: A multicenter retrospective study in clinical practice. [2017]
Cariprazine: First Global Approval. [2018]
Cariprazine:New dopamine biased agonist for neuropsychiatric disorders. [2017]
Cariprazine: A Review in Schizophrenia. [2018]
Cariprazine: chemistry, pharmacodynamics, pharmacokinetics, and metabolism, clinical efficacy, safety, and tolerability. [2022]
Case Report: Long-Acting Oral Cariprazine. [2023]