Status:
COMPLETED
PDC-1421 Treatment in Adult Patients With ADHD
Lead Sponsor:
BioLite, Inc.
Collaborating Sponsors:
ABVC BioPharma, Inc
Conditions:
Attention-Deficit Hyperactivity Disorder (ADHD)
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Part II is a double-blind, randomized, parallel-group, placebo-controlled study. The primary objective of this trial is to determine the effective doses and treatment period of PDC-1421 Capsule in sub...
Detailed Description
The screening phase is intended for diagnosing and assessing the patient for possible inclusion in the study and for providing an adequate washout period. At the first stage, a number of 69 subjects ...
Eligibility Criteria
Inclusion
- 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, 5th Edition (DSM-5)
- A total score of 28 or higher of ADHD Rating Scale-Investigator Rated (ADHD-RS-IV) at screening
- Have a moderate or severe symptom of ADHD with score of 4 or higher in Clinical Global Impression- Severity (CGI-S) at screening
Exclusion
- Have any clinically significant concurrent medical condition (endocrine, renal, respiratory, cardiovascular, hematological, immunological, cerebrovascular, neurological, anorexia, obesity or malignancy) that has become unstable and may interfere with the interpretation of safety and efficacy evaluations
- 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
- Have known serological evidence of human immunodeficiency virus (HIV) antibody
- Are pregnant as confirmed by a positive pregnancy test at screening
- Have QTc values \>450 msec at screening using Fridericia's QTc formula
- Have current of bipolar and psychotic disorders
- Have a current major depression disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, panic disorder and eating disorder (also if treated but not currently symptomatic) NOTE: Comorbid diagnoses identified during screening and baseline are acceptable provided that ADHD is the primary diagnosis and the comorbid diagnoses will not confound study data or impair subject's ability to participate (per the Investigator's judgement and documented in source note).
- Have any history of a significant suicide attempt, or possess a current risk of attempting suicide, in the investigator's opinion, based on clinical interview and responses provided on the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Have a history of jailing or imprisonment in the past 6 months due to worsening of symptoms of ADHD
Key Trial Info
Start Date :
April 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05202327
Start Date
April 7 2022
End Date
December 6 2023
Last Update
August 9 2024
Active Locations (6)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
3
National Taiwan University Hospital
Taipei, Taiwan, 10002
4
Cheng Hsin General Hospital
Taipei, Taiwan, 112