Omega-3 Fatty Acids as an Adjunctive Therapy for Stimulants in Children With ADHD

NCT01778647 | Terminated Phase 4 DMC

• 2 other identifiers: LVZ11360709/06/VA05
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple forms of Omega-3 Fatty acids have been used to investigate the role of this food supplement in children with Attention Deficit Hyperactivity Disorder (ADHD). No clear evidence for their role in this disorder is yet available. We will conduct a prospective, randomized, double blind, placebo controlled trial to obtain significant results regarding this question.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Omega- 3 Fatty acids; CGI; Conners rating scale; Stimulants

Outcome Measures

Primary Outcomes (1)

• Conners Rating Scale for assessment of ADHD characteristics

  Conners Rating Scales is designed to provide an overview of child and adolescent concerns and disorders, including ADHD. The survey for parents contains 80 items and 59 items for teachers. Scoring is based on a response about specific aspects of child behavior, with a low cumulative score showing less likelihood of a specific disorder. The cumulative score is called a T-score. T-scores have a mean of 50 and a standard deviation of 10. These can be converted to percentile scores. T-scores above 60 are cause for concern and have interpretive value. Interpretable scores range from a low T-score of 61 (mildly atypical) to above 70 (markedly atypical).

  16 WEEKS

Secondary Outcomes (1)

• Clinical Global Impression - Severity Scale (CGI-S)

  16 WEEKS

Study Arms (2)

Stimulants plus Lovaza

EXPERIMENTAL

Usual dose of stimulant plus Lovaza (prescription Omega-3 fatty acids) at a dose of 1800 mg daily.

Dietary Supplement: Stimulants plus Lovaza

Stimulants plus placebo

PLACEBO COMPARATOR

Usual dose of stimulants plus placebo(corn oil), which will be given to the patients by MMC's pharmacy.

Drug: Stimulants plus placebo

Interventions

Stimulants plus Lovaza DIETARY_SUPPLEMENT

Patients randomized to stimulants plus Lovaza (Omega-3 fatty acids). Treated and evaluated for up to 16 weeks. Conners and CGI scales filled out by parents, teachers and evaluators on each visit

Also known as: Lovaza plus stimulants

Stimulants plus Lovaza

Stimulants plus placebo DRUG

Patients randomized to usual dose of stimulants plus placebo. Patients evaluated for up to 16 weeks. Conners rating scales and CGI filled out by evaluators, parents and teachers.

Also known as: Sugar pill plus stimulants

Stimulants plus placebo

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female Children 6 to 15 years old
• Diagnosis of ADHD according to the DSM IV -TR

You may not qualify if:

• Children younger than 6 y/o or older than 15 y/o
• Children with other co-morbid disorders according to the DSM IV-TR
• Mentally retarded children
• Poor compliance with treatment
• Children with a diagnosis of blood clotting problems
• Children on anticoagulants
• Children with hypersensitivity to fish
• Children "In care" (CiC): Foster children or children that are not being taken care of by a biological parent or a legal guardian.
• Children who follow a kosher diet (Lovaza is not kosher)
• Pregnancy

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (1)

• Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.

  PMID: 37058600 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Central Nervous System Stimulants; Omacor; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Carbohydrates

Study Officials

• Kathleen Malloy, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

• Juan D Pedraza, MD

  Maimonides Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Administration Director

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: January 29, 2013
• Study Start: December 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

US (1)