Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety and Efficacy of Aripiprazole in the Long-term Maintenance Treatment of Pediatric Patients With Irritability Associated With Autistic Disorder
Brief Summary: The purpose of this study is to determine whether pediatric participants with irritability associated with autistic disorder who have responded to aripiprazole treatment will experience a relapse significantly later when continuing therapy with aripiprazole than will participants who receive placebo


Options:
A: Inclusion Criteria:

* Patients with a diagnosis of Autistic Disorder as defined by DSM-IV, confirmed by the team and supported with the Autistic Diagnostic Observation Schedule (ADOS)
* Male adults, 18 to 45 years of age
* IQ \> 70 (Wechsler Adult Intelligence Scale-Full scale)
* Body mass index (BMI) 18 to 35 kg/m2 inclusive
* Aberrant Behavior Checklist (ABC) - Irritability subscale score \</= 13

Exclusion Criteria:

* Positive urine test for drugs of abuse
* Alcohol and/or substance abuse/dependence during the last 12 months
* Positive for hepatitis B, hepatitis C or HIV infection
* Clinically relevant cardiovascular, renal, hepatic or hematologic disease or disorder
* Active inflammatory pulmonary disease
* History of epilepsy/seizure disorder (except for simple febrile seizures)
* Initiation of new or major change in psychosocial intervention within 4 weeks prior to randomization
* Treatment with any investigational agent within 90 days prior to screening
* History of hypersensitivity or allergic reactions
B: Inclusion Criteria:

* Meets DSM-IV, ADI-R criteria for autistic disorder.
* Age 5-17 years.
* Outpatients
* Parent or legal guardian willing to sign informed consent.

Exclusion Criteria:

* Subject has been diagnosed with a psychotic disorder (such as schizophrenia) or a mood disorder, including depression or bipolar disorder (manic depression).
* Subject has caused visible harm to him/herself.
* Subject has an active seizure disorder or epilepsy (seizures within the past year).
* Subject has an unstable medical illness, including heart disease.
* Subject has experienced brain injury.
* Subject has a history of diabetes.
* Subject reports significant improvement of autism symptoms and behaviors to current medication or other therapies.
* Subject has a history of prior treatment with Aripiprazole of 5 mg/day or higher for 6 weeks.
* Subject lives in a far away area and/or does not have regular access to transportation to the clinical facility.
* Subject is a pregnant female or unwilling to use acceptable contraception if sexually active.
C: Inclusion Criteria:

* Children from 3 to 10 years old, answering the diagnosis of typical autism according to the diagnostic criteria of autism of the classification of the WHO ( CIM-10) and the parents of which gave a free, enlightened and written consent.

Exclusion Criteria:

* Patients epileptic autistics treated by anticomitiaux or having hurts of the central nervous system
* Patients autistics receiving a psychotropic treatment
* Patients presenting disorders electrolytes
* Patients presenting a hypersensibility known about sulpha drugs
* Presenting patients against indications relative to the treatment by bumetanide
* Patients already treated by diuretics
* Patients presenting a hepatic or renal incapacity
* Patients presenting an elongation of the QT to the electrocardiogram.
* Patients autistics of CARS sore is lower than 30.
D: Key Inclusion Criteria:

* Male or female children or adolescents, 6 to 17 years of age, inclusive, at the time of the baseline visit
* Meets current diagnostic criteria of the Diagnostic and Statistical Manual-of Mental Disorders IV-Text Revised for autistic disorder and displays behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems. Diagnosis of autistic disorder will be confirmed by the Autism Diagnostic Interview-Revised.
* Participant or designated guardian or caregiver is able to comprehend and satisfactorily comply with the protocol requirements, in the opinion of the investigator.
* Demonstrates behaviors such as tantrums, aggression, or self-injury or a combination of these problems
* An Aberrant Behavior Checklist Irritability subscale score ≥18 AND a Clinical Global Impressions Severity score ≥4 at the Screening and Baseline Visits.
* Mental age of at least 24 months

Key Exclusion Criteria:

* Treatment resistant to neuroleptic medication, based on lack of therapeutic response to 2 different neuroleptics after treatment for at least 3 weeks each.
* Previous treatment with aripiprazole for at least 3 weeks duration at an adequate daily dose, without demonstrating a clinically meaningful response.
* Lifetime diagnosis of bipolar disorder, psychosis, or schizophrenia, or a current diagnosis of major depressive disorder
* Diagnosis of Pervasive Developmental Disorder-Not Otherwise Specified, Asperger's Syndrome, Rett's Syndrome, childhood disintegrative disorder, or Fragile X Syndrome
* History of neuroleptic malignant syndrome
* At significant risk for suicide based on history or routine psychiatric status examination
* A seizure within the past year
* History of severe head trauma or stroke
* History or current evidence of any unstable medical conditions that would expose the patient to undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial
* Weight lower than 15 kg
* Known allergy or hypersensitivity to aripiprazole or other dihidrocarbostyrils
* History of a clinically significant low white blood cell count or a drug-induced leukopenia/neutropenia
* Any other medically significant abnormal laboratory test or vital sign result or electrocardiogram finding

Answer: D