Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Forced-dose Titration, Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
Brief Summary: The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and 37.5 mg) given to participants daily in the morning compared to placebo in the treatment of adults aged 18 to 55 years diagnosed with ADHD.


Options:
A: Inclusion Criteria:

1. Men and women between the ages of 18-60 who meet DSM-IV criteria for current cocaine dependence and adult ADHD (DSM-IV-TR).
2. Used cocaine at least four days in the past month
3. Must have a Body Mass Index (BMI) \> 18 kg/m2
4. Alcohol Breathalyzer (BraC) at consent of \< 0.04%
5. Individuals must be capable of giving informed consent and capable of complying with study procedures.
6. Women of child bearing age will be included in the study provided that they are not pregnant, based on the results of a blood pregnancy test drawn at the time of screening. They must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study medication. If a woman becomes pregnant, the study medication will be discontinued.

Exclusion Criteria:

1. Meets DSM-IV-TR criteria for bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse.
2. Individuals with any current Axis I psychiatric disorder as defined by DSM-IV-TR supported by the SCID-I/P that in the investigator's judgment are unstable or would be disrupted by study medication or are likely to require pharmacotherapy during the study period.
3. Individuals with current major depressive disorder.However,individuals who are currently stable on a psychotropic medication for three months with a HAM-D \<14 may be included.
4. Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention.
5. Individuals with current suicidal risk.
6. Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG, cardiac symptoms, fainting, open-heart surgery and/or arrhythmia, and family history of ventricular tachycardia/sudden death.
7. Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension (SBP \> 140, DBP\> 90, or HR \> 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases \< 3x upper limit of normal are acceptable), or uncontrolled diabetes.
8. Individuals with a history of seizures
9. History of allergic reaction to candidate medication (amphetamine and/or ER-MAS).
10. Women who are pregnant or nursing.
11. History of failure to respond to a previous adequate trial of the candidate medication for cocaine dependence
12. Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program
13. History of glaucoma
14. Individuals who report use of MAOI within 14 days of study start
B: Inclusion Criteria:

* Must be 18-55 years of age, inclusive.
* Must be male or non-pregnant female. Females of childbearing potential (FOCP) must use contraception.
* Must have a medical assessment with no clinically significant or relevant abnormalities as determined by medical history, PE, clinical and lab evaluation.
* Must have 12-lead ECGs defined by the following parameters:

  1. QT/QTcF interval \< 450 msec for males and \< 470 msec for females
  2. Resting heart rate is between 40 and 100 beats per minute
  3. P-R interval \< 200 msec
  4. QRS interval \<110 msec.
* Meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM-IV-TR™) criteria for a primary diagnosis of ADHD (diagnostic code 314.00 and 314.01) established by a psychiatric evaluation that reviews DSM-IV-TR™ criteria with at least 6 of the 9 subtype criteria met. The Adult ADHD Clinical Diagnostic Scale (ACDS v1.2) will be utilized as the diagnostic tool.
* Has a baseline ADHD-RS score greater than or equal to 28 assessed using adult DSM-IV prompts.
* Understands and is able, willing, and likely to fully comply with the study procedures and restrictions.
* Has given written informed consent to participate in the study in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines and applicable regulations before completing any study procedures.

Exclusion Criteria:

* In the opinion of the investigator, the subject is significantly underweight \[e.g., Body Mass Index (BMI) \< 18.5\] or morbidly obese.
* Has any comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders including Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder or other symptomatic manifestations that will contraindicate NRP104 treatment or confound efficacy or safety assessments. Specifically, subjects with mild to moderate forms of Axis I disorders including social phobia and dysthymia may be included while subjects with a lifetime history of psychosis or bipolar disorder will be excluded from participation. Comorbid psychiatric diagnoses will be established by a psychiatric evaluation that includes the Structured Clinical Interview for DSM-IV-TR™ disorders (SCID-I) interview at the screening visit.
* Has any concurrent chronic or acute illness or unstable medical condition that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol. Subjects with mental retardation or a severe learning disability are excluded.
* Has a history of seizure (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
* Has a known cardiac structural abnormality or any other condition that may affect cardiac performance.
* Has any clinically significant ECG or laboratory abnormality at Screening or Baseline.
* Subject has a history of hypertension or has a resting sitting systolic blood pressure \> 139mmHg or diastolic blood pressure \> 89mmHg.
* Has used any prohibited medication except for ADHD medications within 30 days of screening visit. Hormonal contraceptives are acceptable.
* Has a documented allergy, intolerance, or documented history of non-responsivity to methylphenidate or amphetamine.
* Currently has (or had a history within the last 6 months of) a drug dependence or substance abuse disorder according to DSM-IV-TR™ criteria (excluding nicotine) as established by a SCID-I at the screening visit.
* Has a positive urine drug result at Screening (with the exception of subject's current stimulant therapy, if any) or at Baseline.
* Has taken an investigational drug or taken part in a clinical trial within 30 days prior to Screening.
* The female subject is pregnant or lactating.
C: Inclusion Criteria:

* Diagnosis of Dementia of the Alzheimer's Type
* Ambulatory, Outpatients who have an informant living/visiting at least 8 hours/week over 3-4 days.
* Presence of delusions, hallucinations, agitation impacting functioning and requiring medication treatment
* Agitation or psychotic symptoms began after signs or symptoms of dementia

Exclusion (prospective participants must not:)

* Be benefiting from psychotropic medication, antidepressants or anticonvulsants
* Be diagnosed with schizophrenia, schizoaffective disorder, delusional disorder or mood disorder with psychotic features.
* Have severe or unstable medical illness requiring active treatment
* Have hypersensitivity or intolerance of any of the study medications
D: Inclusion Criteria:

Subject must be 18-55 years of age

Subject is able to provide written, personally signed and dated informed consent.

Subject is willing and able to comply with all of the testing and requirements defined in the protocol

Subject, who is a female, must not be pregnant.

Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities.

Subject has a primary diagnosis of ADHD.

Subject has an adult ADHD-RS with prompts total score ≥28 at the baseline visit.

Subject must have a minimum level of intellectual functioning, as determined by the investigator.

Subject is able to swallow a capsule.

Subject is currently not on ADHD therapy or is not completely satisfied with any aspect of their current ADHD therapy.

Exclusion Criteria:

Subject has a current, comorbid psychiatric diagnosis with significant symptoms.

Subject is considered a suicide risk in the opinion of the investigator

Subject has a body mass index (BMI) of \<18.5 kg/m2 at the screening visit.

Subject has a BMI ≥40 kg/m2 at the screening visit.

Subject has a concurrent chronic or acute illness, disability, or other condition.

Subject has a history of seizure, a chronic or current tic disorder, or a current diagnosis of Tourette's disorder.

Subject has a history of moderate to severe hypertension.

Subject has a known history of symptomatic cardiovascular disease

Subject has a known family history of sudden cardiac death or ventricular arrhythmia.

Subject has any clinically significant ECG or clinically significant laboratory abnormality at the screening visit.

Subject has current abnormal thyroid function

Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.

Subject has failed to respond, to an adequate course(s) of amphetamine therapy.

Subject has a history of suspected substance abuse or dependence disorder.

Subject has a positive urine drug result at the screening visit (with the exception of subject's current stimulant therapy, if any) or Subject has taken another investigational product or has taken part in a clinical study within 30 days prior to the screening visit.

Subject has previously completed, has discontinued, or was withdrawn from this study.

Subject is taking any medication that is excluded or has not been appropriately washed out according to the protocol requirements.

Subject is required to take or anticipates the need to take medications that have CNS effects or affect performance.

Subject is female and is pregnant or lactating.

Answer: D