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

NCT04843423 | Unknown Phase 4 FDA Drug

• 1 other identifier: IIT-2018-10403
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Inattention; Impulsive; Hyperactive; Non-remitting; Treatment resistant

Outcome Measures

Primary Outcomes (1)

• Mean changes in the ADHD Rating Scale (ADHD RS-5)

  Remission cut off score is defined as less than or equal to 18

  Pre treatment (screening, week 0) and post treatment (week 8)

Secondary Outcomes (10)

• Mean changes on the Barkley Adult ADHD Rating Scale IV (BAARS-IV)

  Pre treatment (screening, week 0) and post treatment (week 8)

• Mean changes on the Adult ADHD Self-Report Scale (ASRS) v1.1

  Pre treatment (screening, week 0) and post treatment (week 8)

• Mean changes on the Intolerance of Uncertainty Scale (IUS)

  Pre treatment (screening, week 0) and post treatment (week 8)

• Mean changes on the Clinical Global Impression - Severity (CGI-S) scale

  Pre treatment (screening, week 0) and post treatment (week 8)

• Mean changes in on the Time Sensitive ADHD Symptom Scale (TASS)

  Pre treatment (screening, week 0) and post treatment (week 8)

Study Arms (1)

Cariprazine treatment

EXPERIMENTAL

Drug: Cariprazine

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.

Cariprazine treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participants who score an ASRS of ≥ 4 in Part A at both Screening and Baseline, representing non-response to current stable psychostimulant treatment
• Participants are on a stable dose (\> 4 weeks) of their existing long-acting psychostimulant (any type) prior to entry into the study.
• Participants are on a stable dose of any other psychotropic medication (\> 8 weeks) to treat comorbid conditions, except antipsychotics.
• On the basis of a physical examination, medical history and basic laboratory screening, the patient is, in the investigator's opinion, in a suitable condition.
• Basic laboratory screening includes:
• Chemistry: Electrolytes, ALT, Albumin, Alkaline Phosphatase, AST, Bilirubin Total protein, Creatinine, Urea (BUN), CK, GGT, Potassium, Sodium, Calcium, Glucose (Fasting), Bilirubin Direct, Bicarbonate, Chloride, Urate (for Uric Acid), LD, Magnesium, Phosphorus, Amylase CBC: Hematocrit, Hemoglobin, RBC, WBC + differential, abs. Platelet Count Drug Screen (urine-8 tests): amphetamines, benzodiazepines, barbiturates, methadone, cocaine, opiates, cannabinoids, PCP Standard Urinalysis Lipid Assessment: Cholesterol, HDL, LDL-calc, Triglycerides Prolactin
• Willing and able to attend study appointments in the correct time windows.

You may not qualify if:

• Any other primary mental health disorder in the previous six months.
• Alcohol or drug abuse as defined in the DSM-5 criteria within the last six months.
• Mania, hypomania as defined in the DSM-5 criteria.
• Any psychotic disorder.
• Eating disorders as defined in the DSM-5 criteria.
• Any cognitive disorder or dementia within 3 months before the baseline visit.
• A history of Seizure Disorder (Epilepsy or other).
• Clinical interpretation of apparent suicide risk.
• Commencement of formal psychotherapy for 4 weeks prior to entry into the study and/or during the course of the study.
• Existing treatment with any antipsychotic as mono- or adjunct therapy at the time of the study.
• Change in use of medications.
• Laboratory values at screening or in medical history that may be considered through clinical interpretation to be significant, including positive drug and alcohol tests.
• Diseases that could through clinical interpretation interfere with the assessments of safety, tolerability and efficacy of study treatment.
• Serious illness: liver or renal insufficiency, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic or metabolic disturbance.
• 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.

Sponsors & Collaborators

• Dr. Martin A. Katzman: lead

Study Sites (1)

START Clinic for Mood and Anxiety Disorders

Toronto, Ontario, M4W 2N4, Canada

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Impulsive Behavior; Spasm

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Behavior; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin A Katzman, MD

  Clinic Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Fotinos, M.Psy

CONTACT

4165989344; kfotinos@startclinic.ca

Sachin Lokuge, BSc (Hons.)

CONTACT

4165989344; slokuge@startclinic.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinic Director

Model Details: Longitudinal, open-label, single arm, within-subject, adjective flexible-dose intervention study

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 13, 2021
• Study Start: December 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: April 14, 2023
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)