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PDC-1421 for ADHD
Study Summary
This trial is testing a new potential treatment for ADHD, to see if it is effective and safe.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 2 trial • 72 Patients • NCT02395978Trial Design
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Who is running the clinical trial?
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- You have recently tried to harm yourself or are at risk of doing so, according to the doctor's evaluation and a specific questionnaire.My ADHD symptoms are moderate to severe, scoring 4 or higher on the CGI-S.You currently have bipolar disorder or psychotic disorders.I am not pregnant and will use birth control during and 15 days after the study.Your heart's electrical activity, measured by the QTc value, is longer than 450 milliseconds.I do not have any unstable health conditions that could affect the trial's safety or results.You have tested positive for HIV.You have a score of 28 or higher on the ADHD Rating Scale completed by the investigator.You meet specific guidelines for adult ADHD according to the DSM-5.You have been in jail or prison in the past 6 months because your ADHD symptoms got worse.I have or have had major depression, OCD, PTSD, anxiety, panic disorder, or an eating disorder.I am between 18 and 70 years old.I am not pregnant and will use birth control during and 15 days after the study.I can stop taking ADHD medication for the study.You have a high score on the ADHD Rating Scale-Investigator Rated (ADHD-RS-IV) test.
- Group 1: Placebo
- Group 2: Low-dose
- Group 3: High-dose
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Who would this clinical trial be appropriate for?
"This study is enrolling 99 patients with a diagnosis of attention deficit hyperactivity disorder (ADHD). To be eligible for the trial, patients must meet the following criteria: Aged 18-70 years, Female subjects of child-bearing potential must test negative to pregnancy and use appropriate birth control method from the beginning of study to the 15 days later after ending of study, Subjects must be able to understand and willing to sign informed consent, Able to discontinue the use of any psychotropic medications for the treatment of ADHD symptoms at screening, Meet strict operational criteria for adult ADHD according to the Diagnostic and Statistical Manual of Mental Disorders,"
Does this research include individuals outside of the age range of 45 years old?
"112 different clinical trials are available for patients that do not meet the age requirements of this trial. If an applicant is over 65, there are 40 other trials they may be eligible for."
What are the potential side effects of PDC-1421 Capsule?
"While there is some clinical data supporting the safety of PDC-1421 Capsule, it has not been shown to be effective. Therefore, it received a score of 2."
Are there any available openings for patients who want to enroll in this clinical trial?
"That is correct, the trial mentioned is still actively recruiting patients according to information on clinicaltrials.gov. The posting date was April 7th, 2022 and the most recent update was July 18th, 2022. So far, 99 people have been enrolled at 1 location"
How many people can join this clinical trial at most?
"Yes, that is accurate. The most recent update on clinicaltrials.gov shows that this study was posted on 4/7/2022 and updated as recently as 7/18/2022. They are looking for a total of 99 patients from 1 location."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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