Please select the eligibility criteria that correspond to the clinical trial below.
Title: Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Cross-Over Placebo Controlled Trial
Brief Summary: There is a scarcity of clinical trials assessing the effects of medications in children with bipolar disorder. This study aims to assess the efficacy of Aripiprazole associated with Methylphenidate (MPH)for the treatment of children and adolescents with bipolar disorder comorbid with ADHD who improve in maniac symptoms while receiving aripiprazole but did not have an adequate response in ADHD symptoms. The study design is a 4-week randomized, double blind, cross-over group trial. Patients were randomized to aripiprazole + MPH or aripiprazole + placebo. The main hypothesis is: Aripiprazole + MPH will significantly reduce ADHD scores compared to aripiprazole + placebo.


Options:
A: Inclusion Criteria:

* The patient is between 6-12 years old (both inclusive).
* The patient satisfies the DSM-IV criteria for ADHD or ADD.
* The patient has a responsible caregiver who is able to provide information about the patient's functional status.
* Written informed consent is obtained from the patient and the legally accepted representative.

Exclusion Criteria:

* The patient does satisfy the DSM-IV for autism spectrum disorder.
* The patient does have situational hyperactivity, pervasive developmental disorders, schizophrenia, other psychotic disorders such as mood or anxiety disorder, personality disorder as unsocial behaviour, personality change due to a general medical condition, mental retardation (IQ \< 70), understimulating environments, conduct disorder, chorea and other dyskinesias. The patient does not have tics or Tourette's syndrome, or personal or family history of psychotic disorder, bipolar illness, depression, or suicide attempt.
* The patient does have any chronic medical disorder (diabetes, epilepsy or other seizure disorder, autoimmune disorder, gastrointestinal disorder, renal or cardiovascular disorders, etc.) or acute inflammatory disease. The patient does not have glaucoma, heart disease, heart rhythm disorder, high blood pressure, or peripheral vascular disease such as Raynaud's syndrome.
* The patient did use any of these medications during the 3 months before entering the study: clonidine, guanethidine, blood thinners (e.g. warfarin or Coumadin), antidepressants (e.g. amitriptyline, citalopram, doxepin, fluoxetine, nortriptyline, paroxetine, sertraline), cold or allergy medicine that contains a decongestant, medications to treat high or low blood pressure, seizure medicine (e.g. phenobarbital, phenytoin, primidone), or diet pills.
* The patient did take MAO inhibitor (isocarboxazid, linezolid, phenelzine, rasagiline, selegiline or tranylcypromine) in the past 14 days.
* The patient has any other contraindication for the use of methylphenidate.
* The patient did use vitamin/mineral/herbal/omega-3 supplements or other any medication (psychoactive medication, antibiotics, anti-inflammatory drugs, melatonin, etc.) \> 1 week during the 3 months before inclusion.
B: Inclusion Criteria:

* Children and adolescents which are being considered for methylphenidate treatment and therefore referred to computerized cognitive tasks with and without methylphenidate IR use as part of their management

Exclusion Criteria:

* study group: Age fewer than 6 and above 18, history of seizure, head trauma, substance abuse or medication other than stimulants, inability to swallow pills.

Exclusion criteria

* control group: Age fewer than 6 and above 18, history of seizure, head trauma, substance abuse, current medication use. Current or lifetime psychiatric disorders.
C: Inclusion Criteria. Participants for the study must meet all of the following criteria:

1. Consent: The family must provide signature of informed consent by parents or legal guardians.
2. Age at time of Screening: 7 years to 11 years, inclusive
3. Gender: includes male and female children.
4. ADHD Diagnostic Status: ADHD patients must meet DSM-IV criteria for ADHD, Inattentive or Combined subtype. Normal controls must not meet DSM-IV criteria for ADHD, any subtype. Section D.4 below describes in detail the diagnostic process for arriving at diagnosis.
5. Cognitive Functioning: IQ of greater than 80 as estimated by Vocabulary and Block Design subtests of the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV).
6. Learning Disability: All children will be administered the abbreviated WIAT including the Spelling, Reading, and Math subtests. Children must score above 80 on all three WIAT subtests.
7. School: Children must be enrolled in a school setting from which teacher ratings can be obtained.

Exclusion Criteria. Potential participants will be excluded if they meet any of the following criteria:

1. Understanding Level. The patient and parent cannot understand or follow instructions given in the study.
2. History of Psychiatric Medications: Children who have a history of taking any medication for psychological or psychiatric problems will be excluded from participation.
3. Exclusionary Psychiatric Conditions: Children whose primary diagnosis is something other than ADHD will be excluded from participation.
4. Developmental Disabilities. As a result of scores on the IQ screening, additional assessments, or the judgment of the study clinicians, patients will be excluded if they are deemed to be significantly developmentally delayed. This includes clinically significant delays in cognitive function or the presence of other Pervasive Developmental Disorders (PDD).
5. Organic Brain Injury: Children must not have a history of head trauma, neurological disorder, or any other organic disorder that could possibly affect brain function.
D: Inclusion Criteria:

* Age: 8 -17
* BD type I or II comorbid with ADHD
* Reduction of maniac symptoms (30% reduction in the YMRS scores and/or CGI scores ≤ 2)while using aripiprazole during a previous study (NCT00116259)without improvement of ADHD symptoms (reduction in ADHD symptoms \< 30% in the SNAP-IV). Those receiving placebo in the previous protocol will receive a 6- week open label treatment with aripiprazole. The same threshold for reducing maniac symptoms and absence of response in ADHD symptoms will be used.

Exclusion Criteria:

* IQ \< 70
* Pregnancy or absence of a contraceptive method in fertile girls
* Diagnoses: pervasive development disorder, schizophrenia, drug abuse or dependency
* Risk of suicide or homicide
* Clinical condition that might interfere in the study
* Known sensibility to aripiprazole

Answer: D