Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Adhd
• Age: Between 18 years - 55 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Subjects with a current primary DSM-5 diagnosis of ADHD
  2. Subjects who are not receiving any pharmacological treatment for ADHD must have an AISRS score of = 28 at screening.
  3. Subjects are between the ages of 18 to 55 years
  4. Subject have BMI of 18 to 40, inclusive.
  5. Subjects are able to swallow multiple tablets.
  6. Subjects are willing and able to comply with all testing and requirements as defined in this protocol.
  7. Subjects able to provide electronic informed consent to participate in the trial in accordance with the ICH GCP Guidance E6 and applicable regulations before completing any trial-related procedures.
  8. Subjects willing to discontinue all prohibited psychotropic medications
  9. Subjects able to read English or Spanish well enough to understand the nature of the trial and to read and understand the written word in order to complete subject-reported outcome measures and be able to communicate effectively to be reliably rated on assessment scales

  
  

You may not be eligible for this study if the following are true:

• 1. Subjects who are pregnant or breastfeeding
  2. Sexually active males or FOCBP who do not agree to practice 2 different methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of IMP for female subjects, and 90 days after the last dose of IMP for male subjects and their partners who are FOCBP.
  3. Subjects who have a DSM-5 diagnosis of Other Specified or Unspecified Attention Deficit/Hyperactivity Disorder.
  4. Subjects who initiated, changed, or discontinued receiving psychological (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) interventions for ADHD
  5. Subjects with lifetime history of electroconvulsive therapy, or a lifetime history of vagal nerve stimulation or deep brain stimulation for the treatment of depression.
  6. Subjects have current comorbid psychiatric disorder that either could be expected to require treatment with medications prohibited in this trial, or to confound efficacy or safety assessments.
  7. Subjects with a clinically significant current DSM-5 diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, histrionic, narcissistic, avoidant, or dependent personality disorders.
  8. Subjects who meet criteria for C-SSRS Suicidal Ideation Items 4 or 5
  9. Subjects who had any medical or psychological condition(s) or state(s) that in the investigator’s opinion would prohibit the subject from completing the trial or would go against the subject’s best interest with his/her participation in the trial.
  10. Subjects who have history of epilepsy, seizures
  11. Subjects who had life-time history of a pattern of abuse or diversion of stimulants.
  12. Subjects with any current or suspected drug or alcohol use disorder.
  13. Subjects with a positive alcohol test (via breathalyzer or blood), a positive drug screen for cocaine, or other illicit drugs (excluding marijuana).
  14. Subjects with known intellectual disability or clinical evidence of intellectual disability based on the opinion of the investigator.
  15. Subjects with insulin-dependent diabetes mellitus are excluded.
  16. Subjects presenting with, or having a history of, uncontrolled hypertension or symptomatic hypotension
  17. Subjects with known ischemic heart disease or history of myocardial infarction, congestive heart failure
  18. Subjects with hypothyroidism or hyperthyroidism
  19. Subjects receiving any of the prohibited medications
  20. Subject has a history of prior exposure to centanafadine.
  21. Subject has a history of dermatologic adverse reactions or anaphylaxis secondary to drug exposure.
  22. Subject has participated in a clinical trial involving either an investigational medication or a non-medication intervention
  23. Subject has previously been randomized in this trial and subsequently withdrawn.
  24. Subjects with HIV seropositive status/acquired immunodeficiency syndrome, seropositive status for hepatitis B (ie, HBsAg positive), or hepatitis C (ie, anti-HCV positive and HCV RNA positive).
  25. Any subject who, in the opinion of the investigator, should not participate in the trial.