Carnitine as an Adjunct to Methylphenidate for the Treatment of Attention Deficit Hyperactivity Disorder

NCT01099072 | Unknown Phase 2 DMC

• 1 other identifier: 8642
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; carnitine; methylphenidate

Outcome Measures

Primary Outcomes (1)

• The principal measure of outcome will be the Parent and Teacher ADHD Rating Scale-IV

  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.

  6 weeks

Study Arms (2)

Methylphenidate+placebo

ACTIVE COMPARATOR

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

Drug: Methylphenidate+placebo

methylphenidate+carnitine

EXPERIMENTAL

Drug: methylphenidate+carnitine

Interventions

Methylphenidate+placebo DRUG

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

Methylphenidate+placebo

methylphenidate+carnitine DRUG

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 )

methylphenidate+carnitine

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Tehran Province, 13337, Iran

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Shahin Akhondzadeh, Ph.D.

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2010
• First Posted: April 6, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 7, 2012

Record last verified: 2012-12

Locations

IR (1)