To evaluate the long-term safety and tolerability of SEP 225289 in adult subjects with Attention Deficit Hyperactivity Disorder (ADHD)
To evaluate the long-term safety and tolerability of SEP 225289 in adult subjects with ADHD by the incidence of adverse events (AEs; or serious AEs), AEs (or SAEs) leading to discontinuation
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
724
Dasotraline 4 mg, 6 mg, 8 mg, flexibly dosed, once daily
The incidence of AEs (or SAEs), and AEs (or SAEs) leading to discontinuation.
Time frame: 12 months
Clinical evaluations (vital signs, physical examination, body weight, and 12 lead ECG)
Time frame: 12 Months
Clinical laboratory evaluations (serum chemistry, hematology, lipid panel, thyroid panel, and urinalysis)
Time frame: 12 months
Drug Effects Questionnaire (DEQ)
Time frame: 12 months
Frequency and severity of suicidal ideation and suicidal behavior using the Columbia - Suicide Severity Rating Scale (C SSRS)
Time frame: 12 months
Change from baseline in ADHD RS IV with adult prompts total score
Time frame: 12 months
Change from baseline in Clinical Global Impression - Severity (CGI S) score
Time frame: 12 months
Change from baseline in the ADHD RS IV with adult prompts inattentiveness and hyperactivity-impulsivity subscale scores
Time frame: 12 months
Change from baseline in AIM A in global domain scores (Performance and Daily Functioning, Impact of Symptoms: Daily Interference, Impact of Symptoms: Bother/Concern, Relationships/Communication, Living with ADHD, and General Well-being)
Time frame: 12 months
Change from baseline in Sheehan Disability Scale (SDS) total score
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Southern California Research LLC
Beverly Hills, California, United States
Pharmacology Research Institute
Encino, California, United States
Synergy Clinical Research of Escondido
Escondido, California, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
Excell Research, Inc
Oceanside, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, United States
Florida Clinical Research Center LLC
Bradenton, Florida, United States
Gulfcoast Clinical Research
Fort Myers, Florida, United States
...and 55 more locations
Time frame: 12 months
Change from baseline in Sheehan Disability Scale (SDS) domain scores: work/school, family life, social life
Time frame: 12 months
Change from baseline in Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF®) A Global Executive Composite raw score and Behavioral Regulation Index (BRI) raw score and Metacognition Index (MI) raw score.
Time frame: 12 months
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) global score and 7 component scores.
Time frame: 12 months
Change from baseline in BRIEF-A Global Executive Composite T-score and BRI T-score and MI T-score.
Time frame: 12 months
Symptoms of withdrawal using Physician Withdrawal Checklist (PWC) scores, Study Medication Withdrawal Questionnaire (SMWQ) scores, Montgomery-Asberg Depression Rating Scale (MADRS) scores, Hamilton Anxiety Rating Scale (HAM-A) scores
Time frame: 12 months