Adults with ADHD and Anxiety

Attention-deficit/Hyperactivity Disorder and Comorbid Anxiety

Study Specific Details:

Centanafadine vs Placebo – This is a phase 3b, randomized, double blind, placebo-controlled trial.
8 visits over a 3-month study period.
Participant is reimbursed for their time and travel.

Male or Female, ages 19-65.
Currently meets a primary diagnosis of ADHD per the DSM-5 criteria.
Currently meets a secondary diagnosis of Generalized Anxiety Disorder or Social Anxiety Disorder per the DSM-5 criteria.
BMI 18-40 kg
Individual or group psychotherapy is allowed if initiated for at least 3 months before screening and is not expected to change in frequency or type through the duration of the study.
Allowed medications: Non-sedating antihistamine(s), stable, intermittent use of bronchodilators, saline and corticosteroid nasal sprays for the treatment of illness or seasonal allergies, hormonal contraceptives, Trazadone (up to 100 mg per day), certain sleep aides (no more than 3 days per week).

Any disorder that is the primary focus of treatment other than ADHD.
Has failed 2 or more ADHD therapies of 2 different classes (eg, amphetamine and methylphenidate, or amphetamine and atomoxetine) given with an acceptable dose and duration during adulthood.
Has failed 2 or more anxiety therapies of 2 different classes (eg, selegiline and duloxetine, or buspirone and lorazepam) given an acceptable dose and duration during adulthood.
Current psychosis, bipolar disorder, MDD, PTSD, OCD, dementia, personality disorder(s), substance/medication induced anxiety, anxiety disorder due to another medical condition, select mutism.
Fluoxetine is prohibited within 28 days of randomization.
Suicidal ideation in the past 6 months, suicide attempt in the past year.
History of seizure disorder, except for a single febrile seizure.
Substance abuse disorder in the past 12 months.
A history of any prior exposure to centanafadine.
Excluded medications: Antidepressants, Antipsychotics, Benzodiazepines, Hypnotics, including non-benzodiazepine sleep aids, ADHD medications, Sedating antihistamines, antihypertensives (clonidine, propranolol, guanfacine), and anorexics

Want to learn more about Harmonex Neuroscience Research?