Role of Coenzyme Q in ADHD in Children

December 29, 2019 updated by: Sherief Abd-Elsalam

Role of Coenzyme Q in Treatment of Attention Deficit Hyperactivity Disorder in Children

Role of Coenzyme Q in ADHD in Children

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Role of Coenzyme Q in ADHD in Children: will it add a benefit?

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Recruiting
        • Sherief Abd-Elsalam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with ADHD

Exclusion Criteria:

  • Comorbidities like Autism, Anxiety, Obsessive compulsive disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Atomoxetine and Coenzyme Q
Drug: Atomoxetine
Atomoxetine once daily
Other Names:
  • atomox
Drug: Coenzyme Q
Coenzyme Q once daily
PLACEBO_COMPARATOR: Placebo and Atomoxetine
Placebo and Coenzyme Q
Drug: Coenzyme Q
Coenzyme Q once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with improved CONNERS scale
Time Frame: 6 months
The number of patients with improved CONNERS scale
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sherief Abd-Elsalam

Investigators

  • Principal Investigator: Fatma G. Abdelkader, Msc, Pediatrics department - Kafr Elsheikh University
  • Principal Investigator: Osama A Elagamy, Prof., Pediatrics department - Kafr Elsheikh University
  • Principal Investigator: Abeer Salamah, Lecturer, Pediatrics department - Kafr Elsheikh University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2030

Study Completion (ANTICIPATED)

December 1, 2030

Study Registration Dates

First Submitted

December 29, 2019

First Submitted That Met QC Criteria

December 29, 2019

First Posted (ACTUAL)

January 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 29, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • abeer salamah

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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