PDC-1421 for ADHD

Recruiting at 6 trial locations

Overseen By Shirley Chiu, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BioLite, Inc.

Must not be taking: Psychotropics

Disqualifiers: Bipolar, Major depression, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new capsule called PDC-1421 to help people with ADHD. It aims to find the best and safest dose by giving different amounts to participants. The study will check how well the capsule works and if it is safe.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any psychotropic medications (drugs that affect mood, perception, or behavior) for the treatment of ADHD symptoms before joining the study.

Research Team

Keith McBurnett, Ph.D.

Principal Investigator

University of California, San Francisco

Eligibility Criteria

Adults aged 18-70 with a confirmed diagnosis of ADHD, who score at least 28 on the ADHD-RS-IV and have moderate to severe symptoms. Participants must be able to stop taking other psychotropic medications for ADHD and use birth control if applicable. Those with unstable medical conditions or significant mental health disorders are excluded.

Inclusion Criteria

My ADHD symptoms are moderate to severe, scoring 4 or higher on the CGI-S.

I am not pregnant and will use birth control during and 15 days after the study.

You have a score of 28 or higher on the ADHD Rating Scale completed by the investigator.

Exclusion Criteria

You have recently tried to harm yourself or are at risk of doing so, according to the doctor's evaluation and a specific questionnaire.

You currently have bipolar disorder or psychotic disorders.

Have any clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings at screening that, in the opinion of the investigator, may interfere with the interpretation of safety or efficacy evaluations

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either PDC-1421 or placebo capsules thrice daily for 8 weeks

8 weeks

4 visits (in-person) every two weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• PDC-1421 Capsule

Trial Overview The trial is testing PDC-1421 Capsule's effectiveness in different doses compared to a placebo over a set period. It's designed as a double-blind study, meaning neither participants nor researchers know who receives the actual drug versus the placebo.

Participant Groups

Group I: Low-dose Experimental Treatment 2 Interventions

One placebo capsule and 1 PDC-1421 Capsule, thrice daily for 56 days (8 weeks).

Group II: High-dose Experimental Treatment 1 Intervention

Two PDC-1421 Capsules thrice daily for 56 days (8 weeks).

Group III: Placebo Placebo Group 1 Intervention

Two placebo capsules thrice daily for 56 days (8 weeks).

Who Is Running the Clinical Trial?

BioLite, Inc.

Lead Sponsor

Trials

7

Recruited

290+

ABVC BioPharma, Inc

Collaborator

Trials

2

Recruited

110+