Please select the eligibility criteria that correspond to the clinical trial below.
Title: Methylphenidate for Hyperactivity and Impulsiveness in Children and Adolescents With Pervasive Developmental Disorders
Brief Summary: This study will evaluate the efficacy and safety of methylphenidate for treating hyperactivity, impulsiveness, and distractibility in 60 children and adolescents with Pervasive Developmental Disorders (PDD). Methylphenidate (Ritalin)is approved by the Food and Drug Administration for the treatment of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). Data supporting its safety and effectiveness in treating ADHD symptoms in PDD are limited. Children and adolescents who do not show a positive response to methylphenidate will be invited to participate in a pilot study of the non-stimulant medication guanfacine (Tenex).


Options:
A: Inclusion criteria:

* A formal diagnosis of Autism or Pervasive Developmental Disorder not otherwise specified (PDD-NOS), given by a child neurologist.
* Age: 10-18 years.
* A signed parental consent form.

Exclusion criteria:

* Evidence for one of the following conditions:

  * an underlying infectious disease
  * chromosomal abnormality
  * metabolic disorder
  * specific brain related disorder (such as tuberous sclerosis)
  * history of fetal cytomegalovirus infection
  * birth asphyxia
  * a history of major head injury
  * a chronic use of non-steroidal anti-inflammatory drugs, (NSAID)
  * known brain damage
* Epilepsy
* Abnormal Electro-cardiogram (ECG)
* Epileptiform EEG
* Use of psychostimulants, anti-depressants, neuroleptics or anti-convulsive agents within the past month.
* Lack of cooperation in the screening phase
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: * Diagnosis of PDD (including Asperger's Disorder and Autistic Disorder)
* Clinically significant symptoms of ADHD
* Mental age of at least 18 months
* Blood pressure within normal ranges for age and gender
* Weight 16 kg or more
* Absence of chronic tic disorder
* Absence of any medical condition that would be incompatible with the study treatments
* Absence of evidence of hypersensitivity to study treatments
D: 1. Meets DSM-IV, ADI-R and ADOS-G criteria for autistic disorder
2. Age 5-17 years
3. Outpatients
4. Parent or legal guardian willing to sign informed consent.
5. Male or female patients
6. Patient scores at least a "4" (moderately ill) on the Clinical Global Impression Scale for Autistic Disorder (CGI AD).
7. Children who are minimally or non- verbal as indicated by a score of 50% of an 18 month old on the MacArthur Communicative Development Inventory

Exclusion Criteria:

1. Subjects with any of the following past or present mental disorders: psychotic disorders, mood disorders, including bipolar disorders.
2. Subjects who have displayed significant self-injurious behavior (children who have caused visible harm to themselves).
3. Subjects with active seizure disorder (seizures within the past six months).
4. Subjects with clinically significant or unstable medical illness, including patients with current evidence of clinically significant hematopoietic, or cardiovascular disease.
5. Subjects with present or history of the following:

   * gastrointestinal, liver, kidney, or other known conditions which will presently interfere with the absorption, distribution, metabolism, or excretion of drugs,
   * seizure disorders (active), cerebrovascular disease or brain trauma as etiology of autistic behavior,
   * clinically significant unstable endocrine disorder, such as hypo- or hyperthyroidism or diabetes,
   * recent history or presence of any form of malignancy.
6. Subjects who report significant improvement of autism symptoms and behaviors to current medications or have only global autism ratings on the CGI of absent, minimal or mild severity, or who are more than minimally verbal.
7. Subjects whose global autism ratings are assessed as being absent, minimal or mild.
8. Treatment within the previous 30 days with any drug known to have a well-defined potential for toxicity to a major organ.
9. Subjects with clinically significant abnormalities in laboratory tests or physical exam.
10. Subjects likely to require any other psychotropic medication during the study, with the exception of clonidine for insomnia (started at least one month prior to entrance into the study), as well as anticonvulsants at a constant dose for stable seizure disorder or, unless otherwise permitted.
11. Subjects unable to tolerate taper from psychoactive medication, if specified.
12. Subjects with a history of hypersensitivity or severe side effects associated with the use of galantamine, or other acetylcholinesterase inhibitors.
13. Subjects with a history of prior treatment with galantamine of 4mg/day for 6 weeks.
14. Subjects who have received any of the following interventions within the prescribed period before starting treatment:

    * investigational drugs within the previous 30 days.
    * monoamine oxidase inhibitors within the previous fourteen days.
    * long-acting phenothiazines within the previous six weeks.
    * other psychotropic drugs within the previous seven days, unless otherwise permitted.
15. Subjects with any organic or systemic disease or patients who require a therapeutic intervention, not otherwise specified, which would confound the evaluation of the safety of the study medication.
16. Subjects who reside in a remote geographical area or who do not have regular access to transportation to the clinical facility.

Gender

Answer: C