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Cariprazine treatment for Attention Deficit Hyperactivity Disorder (ADHD) (ADHD Trial)

Phase 4
Waitlist Available
Led By Martin A Katzman, MD
Research Sponsored by Dr. Martin A. Katzman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre treatment (screening, week 0) and post treatment (week 8)
Awards & highlights

ADHD Trial Summary

This trial will test the hypothesis that cariprazine will be an effective adjunctive treatment to long-acting psychostimulants in patients with ADHD.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

ADHD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre treatment (screening, week 0) and post treatment (week 8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre treatment (screening, week 0) and post treatment (week 8) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean changes in the ADHD Rating Scale (ADHD RS-5)
Secondary outcome measures
Mean changes in on the Time Sensitive ADHD Symptom Scale (TASS)
Mean changes on the Adult ADHD Self-Report Scale (ASRS) v1.1
Mean changes on the Barkley Adult ADHD Rating Scale IV (BAARS-IV)
+7 more

Side effects data

From 2011 Phase 3 trial • 497 Patients • NCT01058668
17%
Akathisia
11%
Headache
10%
Nausea
10%
Extrapyramidal disorder
10%
Insomnia
9%
Vomiting
9%
Restlessness
5%
Constipation
5%
Dizziness
4%
Dyspepsia
2%
Mania
2%
Diarrhoea
2%
Tremor
1%
Aggression
1%
Hospitalisation
1%
Bipolar disorder
1%
Endometrial cancer
1%
Pulmonary embolism
1%
Bipolar I disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Cariprazine (3-6 mg/Day)
Cariprazine (6-12 mg/Day)

ADHD Trial Design

1Treatment groups
Experimental Treatment
Group I: Cariprazine treatmentExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cariprazine
2010
Completed Phase 3
~11050

Find a Location

Who is running the clinical trial?

Dr. Martin A. KatzmanLead Sponsor
Martin A Katzman, MDPrincipal InvestigatorClinic Director
2 Previous Clinical Trials
92 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to partake in this research endeavor?

"This clinical trial is recruiting 15 participants aged 18 to 70 who are suffering from attention deficit hyperactivity disorder (ADHD). To qualify for the study, individuals must meet numerous criteria including providing written consent, having a primary diagnosis of ADHD as confirmed by DSM-5 and MINI 7.0.2 tests, scoring an Adult Self-Report Scale of ≥ 4 in Part A at Screening and Baseline visits, being on stable doses of psychostimulants or any other psychotropic medications apart from antipsychotics for more than 4 weeks prior to enrollment; passing all biochemical screens such as electrolytes levels assessment and urinalysis with"

Answered by AI

How many participants is this medical experiment enrolling?

"Affirmative. According to clinicaltrials.gov, this medical trial is in a state of active recruitment following its initial posting on December 1st 2021 and subsequent editing on the 13th of that same month. The study demands 15 participants from one designated site."

Answered by AI

Are there vacancies for participants in this medical experiment?

"This trial, first posted on December 1st 2021 and most recently updated on the 13th of that same month, is currently searching for participants as indicated by clinicaltrials.gov."

Answered by AI

Is this the inaugural research effort of its kind?

"Cariprazine has been under investigation since 2019 when the first research trial, sponsored by Allergan and enrolling 330 patients, took place. Subsequent Phase 3 drug approval enabled 8 studies to be conducted across 58 cities in 12 countries."

Answered by AI

Is the age limit for this experiment restricted to octogenarians or younger?

"To be eligible for this study, individuals must fall within the 18 to 70 year old age range. For those younger than 18 or older than 65, there are 110 and 41 clinical trials respectively that may better suit their needs."

Answered by AI

To what extent might Cariprazine be a hazard for those undergoing treatment?

"Cariprazine therapy has been given a score of 3 due to the fact that this is already an approved treatment in its fourth phase of clinical trials."

Answered by AI

Are there any additional examinations that have investigated the use of Cariprazine?

"Currently, 8 clinical trials examining the effects of Cariprazine are active. Of these studies, 5 have reached Phase 3. These investigations can be found in 189 locations with a concentration within Nis and New york City."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
How old are they?
18 - 65
What site did they apply to?
START Clinic for Mood and Anxiety Disorders
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. START Clinic for Mood and Anxiety Disorders: < 48 hours
Average response time
  • < 2 Days
~5 spots leftby Mar 2025