The Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder.

Shalvata Mental Health Center

Status: Unknown

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Methylphenidate

Study type: Interventional

Funder types: Other

Identifiers

NCT01798459

0009-12-SHA

Details and patient eligibility

About

The purpose of the study is to explore the effect of methylphenidate on state anxiety in children with attention deficit hyperactivity disorder.

Patient population: 30 children diagnosed with attention deficit hyperactivity disorder. The subjects will be of all racial, ethnical and gender categories, ranging from 8 to 18 years of age.

Structure: the study is a randomized double blind crossover study. The subjects will complete a continuous performance test, the cambridge neuropsychological test automated Battery, before and after given methylphenidate or placebo on the first day of the study. On the second day of the study, the subjects will receive either methylphenidate or placebo based on what was given on the first day of the study and they will complete the same task.

Enrollment: 30 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Attention deficit and hyperactivity disorder
• Children aged 8-18 years

Exclusion criteria

• Pervasive developmental disorder
• Schizophrenia
• Bipolar disorder
• Current depressive episode
• Current Anxiety disorder
• Drug use during the past 6 months

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Methylphenidate

Active Comparator group

Description:

Methylphenidate 0.3 mg/kg per os is given before performing a continuous performance test.

Treatment:

Drug: Methylphenidate

Placebo

Placebo Comparator group

Description:

Placebo is given before performing a continuous performance test.