Carnitine as an Adjunct to Methylphenidate for the Treatment of Attention Deficit Hyperactivity Disorder
Information source: Tehran University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder
Intervention: Methylphenidate+placebo (Drug); methylphenidate+carnitine (Drug)
Phase: Phase 2
Status: Enrolling by invitation
Sponsored by: Tehran University of Medical Sciences Official(s) and/or principal investigator(s): Shahin Akhondzadeh, Ph.D., Principal Investigator, Affiliation: Tehran University of Medical Sciences
Summary
Attention-deficit hyperactivity disorder (ADHD) is the most common neurobehavioural disorder
of childhood. The investigators hypothesized that carnitine would be beneficial for
treatment of ADHD, and this could be evaluated in a double blind, randomized, parallel group
comparison of carnitine+methylphenidate and methylphenidate +placebo.
This will be a six-week, parallel group, randomized clinical trial undertaken in an
outpatient child and adolescent clinic at Roozbeh Psychiatric Hospital in Tehran, Iran
during April 2010-May 2010.
40 male and female subjects, ages 6 to 17 years with a Diagnostic and Statistical Manual,
Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD will be study population of this
trial. At screening, investigators conduct a psychiatric evaluation with the DSM-IV-TR
criteria for ADHD and the Kiddie Schedule for Affective Disorders and Schizophrenia-Present
and Lifetime diagnostic interview and perform a complete medical history and physical
examination.
The diagnosis of ADHD will be confirmed by a child and adolescent psychiatrist before
participants will be initiated into the study. All patients will be newly diagnosed. Parents
were carefully interview and ask to rate the severity of the DSM-IV-TR ADHD symptoms that
their children display at home. Children will be excluded if they have a history or current
diagnosis of pervasive developmental disorders, schizophrenia or other psychiatric
disorders(DSM-IV axis I); any current psychiatric comorbidity that required pharmacotherapy;
any evidence of suicide risk and mental retardation (I. Q. <70). In addition, patients will
be excluded if they have a clinically significant chronic medical condition, including
organic brain disorder, seizures and, current abuse or dependence on drugs within 6 months.
Additional exclusion criteria will be hypertension, hypotension. To participate, parents and
children have to be willing to comply with all requirements of the study. After a
description of the procedures and purpose of the study, written informed consent will be
obtained from each patient's parent or guardian. Informed consent will receive before the
administration of any study procedure or dispensing of study medication in accordance with
the ethical standards of the investigative site's institutional review board and with the
Helsinki declaration of 1975, as revised in 2000. The protocol will be approved by the
Institutional Review Board (IRB) of Tehran University of Medical Sciences.
Patients will be randomized to receive a carnitine+methylphenidate and methylphenidate
+placebo in a 1: 1 ratio using a computer-generated code.
All study subjects will be randomly assigned to receive treatment using methylphenidate at a
dose of 20-30 mg/day depending on weight (20 mg/day for <30 Kg and 30 mg/day for >30 Kg)+
Carnitine 500-1500 mg/day (depending on weight ) or methylphenidate at a dose of 20-30
mg/day depending on weight (20 mg/day for <30 Kg and 30 mg/day for >30 Kg)+ Placebo for a 6
week double blind, randomized clinical.
The principal measure of outcome will be the Parent and Teacher ADHD Rating Scale-IV that
has been used extensively in Iran in school-age children and provides valid measures of
behavioral abnormality and attention trial.
Side effects will be systematically recorded throughout the study and will be assessed using
a checklist that comprises 20 side effects including psychic, neurologic, autonomic and
other side effects, administered by a child psychiatrist on days 7, 21and 42. Side effects,
administered by a child psychiatrist on days 7, 21and 42.
Clinical Details
Official title: Carnitine as an Adjunct to Methylphenidate for the Treatment of Attention Deficit Hyperactivity Disorder Children and Adolescents in the Placebo Control Double -Blind Randomized Clinical Trail
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The principal measure of outcome will be the Parent and Teacher ADHD Rating Scale-IV
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- The diagnosis of ADHD will be confirmed by a child and adolescent psychiatrist before
participants will be initiated into the study.
- All patients will be newly diagnosed. Parents were carefully interview and ask to
rate the severity of the DSM-IV-TR ADHD symptoms that their children display at home.
Exclusion Criteria:
- Children will be excluded if they have a history or current diagnosis of pervasive
developmental disorders, schizophrenia or other psychiatric disorders(DSM-IV axis I)
- Any current psychiatric comorbidity that required pharmacotherapy
- Any evidence of suicide risk and mental retardation (intelligence quotient [I. Q.]
<70).
- In addition, patients will be excluded if they have a clinically significant chronic
medical condition, including organic brain disorder, seizures and, current abuse or
dependence on drugs within 6 months.
- Additional exclusion criteria will be hypertension, hypotension.
Locations and Contacts
Tehran University of Medical Sciences, Tehran 13337, Iran, Islamic Republic of
Additional Information
Starting date: April 2010
Last updated: December 6, 2012
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