| Eligibility |
Inclusion criteria:
1. Able to provide informed consent prior to any study procedure being conducted.
2. Capable and willing to comply with study procedures.
3. Male or female aged 18 to 64, inclusive.
4. Subjects with a current diagnosis of ADHD as confirmed by the Conners' Adult ADHD
Diagnostic Interview for DSM-IV (CAADID)
5. Clinical Global Impression - Severity (CGI-S) score of 4 or higher.
6. On no treatment for ADHD or willing to be withdrawn from an ongoing treatment after a
washout of at least 10 days.
7. Body Mass Index (BMI) between 18.0 and 34.0 inclusive.
8. Subject must be in general good health as determined by medical history, ECG, and
other analysis that, in the judgment of the Investigator, would confirm the Subject's
good health.
9. Females of childbearing potential (FOCP) who, if sexually active, agree to use
acceptable forms of contraception (including oral, transdermal, or implanted
contraceptives; intrauterine device; female condom with spermicide; diaphragm with
spermicide; cervical cap; abstinence; use of condom with spermicide by sexual partner
or sterile [at least 6 months prior to SM administration] sexual partner) at least 14
days prior to start of study drug administration, throughout the study, and for 30
days following the last dose of SM.
10. Postmenopausal females with amenorrhea for at least 2 years or females who are
permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy).
Exclusion Criteria
1. Current or past history of psychotic disorder or major depressive disorder with
psychotic features.
2. Presence of another primary DSM-IV-TR disorder.
3. Suicidality, defined as either active suicidal plan/intent or active suicidal
thoughts, in the 6 months before the Screening Visit or more than 1 lifetime suicide
attempt. (The Columbia-Suicide Severity Rating Scales [C-SSRS] will be administered at
each visit.)
4. Substance or alcohol abuse/dependence within previous 6 months, or a positive urine
drug screen at screening or baseline prior to first dose of study medication (SM).
5. Any known or suspected significant medical or psychiatric illnesses that, in the
judgment of the Investigator, may impair interpretation of study results or constitute
a significant safety concern in the context of the clinical trial
6. ECG abnormalities (clinically significant according to Investigator's opinion) or
vital sign abnormalities (systolic blood pressure [SBP] <90 or >140 millimeters of
mercury [mmHg], diastolic blood pressure [DBP] <40 or >90mmHg, or heart rate [HR] <40
or >100 beats per minute [BPM]) at screening.
7. Clinically significant laboratory abnormalities; including presence of potential
hepatic function impairment as shown by, but not limited to alanine aminotransferase
(ALT/SGPT) values >2 times upper limit of normal (ULN), aspartate aminotransferase
(AST/SGOT) > 2 times ULN, gamma-glutamyl transpeptidase (GGT) >3 times ULN, or total
bilirubin >1.5 ULN .
8. Medications, including health food supplements judged by the Investigator to be likely
to have central nervous system activity (for example, St John's Wort, gingko leaf, and
melatonin), are not permitted during the study. If the subject is taking the
medication prior to study entry, there must be a 7 day washout period prior to first
dose of SM.
9. Lifetime history of tic disorder, Tourette's Disease, or organic brain disorder; or
family history of Tourette's Disease.
10. Current or lifetime history of hyperthyroidism unless treated and stable for at least
6 months.
11. Participation in or plan to begin behavioral therapy during the study.
12. Subject has a prior history of allergy or any significant adverse reaction (including
rash) to study medication, or any of the product components.
13. Females who are pregnant or lactating or are unwilling to use an acceptable form of
contraception throughout the study.
14. Difficulty swallowing whole capsules.
15. History of seizures or risk factors for seizures (e.g., head trauma), not including
febrile seizures.
16. Use of an investigational drug or participation in an investigational study within 30
days prior to first dose of SM.
17. Any reason which, in the opinion of the Investigator, would prevent the subject from
participating in the study.
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