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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
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

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.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean changes in the ADHD Rating Scale (ADHD RS-5)
Secondary study objectives
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%
Hospitalisation
1%
Aggression
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

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
~4 spots leftby Nov 2025
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