Phase
Condition
Attention Deficit/hyperactivity Disorder (Adhd - Adults)
Williams Syndrome
Treatment
Methylphenidate Hydrochloride Extended Release Capsule
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults ages 18-60 years, inclusive at the time of consent
Able to provide signed informed consent
Any gender
Subjects with a current primary Diagnostic and Statistical Manual of MentalDisorders (DSM) -5 diagnosis of ADHD of predominantly inattentive presentation, orcombined presentations) as confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) Version 1.2.
Subjects who are not receiving any pharmacological treatment for ADHD must have anDSM AISRS 18 item total score of ≥ 28 at screening. Subjects who were previouslyreceiving pharmacological treatment for ADHD at screening must have a minimum totalDSM AISRS 18 item score of ≥ 22 at screening
Dysthymia and anxiety disorders in remission, but stable on psychiatric medicationfor three weeks or more at the discretion of principal investigator will be allowed.Medication for these disorders to remain constant for the duration of the protocol.
Subjects, who have not used stimulant medication in the past 2 months.
Occasional use of marijuana (less than 3 times weekly) will be allowed duringscreening process until subject is enrolled into the study. After subject isenrolled onto Jornay PM, subject is asked to complete an attestation. Theattestation will state that the subject will not consume marijuana while in thestudy.
No illicit substance will be allowed at screening or during the study.
Exclusion
Exclusion Criteria:
Known hypersensitivity to methylphenidate, or product components.
Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOIwithin the preceding 14 days.
Lifetime bipolar disorder, psychotic disorders, autism, intellectual disabilityexcept mood disorders accepted under the inclusion criteria at the discretion of theprincipal investigator.
Active suicidality within past year, or history of suicide attempt in past 2 years
Any history of severe past drug dependence determined by the Mini InternationalNeuropsychiatric Interview (MINI) (i.e., a focus of clinical attention or a cause ofsubstantial social or occupational difficulty)
Concurrent substance abuse and/or history of substance use within 6 months (exceptfor marijuana use of less than three times a week and/or history of excessivemarijuana use of less than three times a week within 6 months).
Use of any prescribed benzodiazepine
Any unstable medical or neurological condition; clinically significant medicalabnormalities such as cardiovascular abnormalities, and any chronic condition of thecentral nervous system
Antidepressants and anti-anxiety agents (including benzodiazepines) taken in stabledoses will be allowed, while other psychotropic medications, includinghallucinogens, mood stabilizers, antipsychotics will not be allowed
Known nonresponse to MPH treatment
History of allergic reaction or sensitivity to MPH
Female of childbearing age, who are breastfeeding, pregnant, planning to be pregnantor men planning to make a woman pregnant during the study or for one-month poststudy
PI/clinician discretion
Study Design
Connect with a study center
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
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