Omega-3 Fatty Acids as an Adjunctive Therapy for Treatment in Attention-Deficit Hyperactivity Disorder (ADHD)

Attention-Deficit/Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01233856
• Other study ID #: 09/06/VA05
• Status: Recruiting
• Phase: N/A
• First received: November 1, 2010
• Last updated: August 25, 2011
• Start date: June 2009
• Est. completion date: June 2012

Study information

• Verified date: August 2011
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Type of study:

This study is a prospective, randomized, placebo controlled, double blind trial comparing the response to treatment in children with a diagnosis of ADHD treated with stimulants and placebo vs. children with a diagnosis of ADHD on stimulants plus Omega-3 fatty acids.

Hypothesis:

The use of Lovaza (prescription Omega-3 fatty acids) as an adjunctive therapy for children with adequate diagnosis of ADHD on treatment with stimulants will not improve their functioning and behavior measured by the Parent and Teacher Conner's Rating Scale and an improvement in their Clinical Global Impression.

Method:

A total of 30-150 patients between ages of 6 and 15 y/o with diagnosis of ADHD according to the DSM-IV-TR and on current treatment with stimulants recruited from CAOS-Maimonides Medical Center and the Developmental Center will be evaluated by a child psychiatrist or a resident under supervision of a child psychiatrist to make sure that the diagnosis is correct. Every child will have a Conners Rating Scale filled out by the parents and teachers on admission to the study. The evaluators will also fill out a Clinical Global Impression Scale (CGI). Patients will be divided in two groups, one will consist of 15 children taking usual dose of stimulants plus placebo and the other group, 15 children will receive the usual dose of stimulant plus Lovaza at a dose of 1800mg daily. Both groups will be treated for 8 weeks. Patients will be re-evaluated by investigators on week 2,4,6 and 8 of the study and on each evaluation the parents and teachers will fill out a Conner's rating scale. Ratings of the Conner's scales filled out for each patient will be analyzed and compared to the initial evaluation after week 8. Evaluators will also obtain a CGI score for each visit. Patients that improve will be taken off the stimulants and will continue further treatment with the adjunctive therapy for a total of 4 more weeks, during this period of time, they will be re-evaluated on weeks 9,10 and 12 and Conner's Scales will also be filled out by parents.

Patients who do not improve will be switched to the opposite treatment modality and will be evaluated on weeks 9,10 and 12 also having Conner's Scales filled out by their parents. If any of the patients in this group improve (after the switch) they will be taken off stimulants and they will be evaluated on weeks 13,14 and 16 of the study arm.

The idea is to conduct the study and obtain information about prescription Omega-3 fatty acids as an adjunct to stimulants for patients with ADHD, as several publications have been done in the past suggesting it can be beneficial, but there have not been any conclusions on whether the treatment is beneficial or not for this population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

Inclusion Criteria:

• Male and female children ages from 6-15 y/o (inclusive)

• Diagnosis of ADHD according to the DSM IV-TR

Exclusion Criteria:

• Children younger than 6 y/o or older than 15 y/o

• Children with other co-morbid disorders according to the DSM IV-TR

• Children with Mental Retardation

• History of poor compliance with treatment

• Children with blood clotting problems

• Children currently under treatment with anticoagulants

• Children with hypersensitivity to fish

• Children "In Care": 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

• Pregnancy

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Lovaza
2000mg daily.

Dietary Supplement:
• Placebo (corn oil).
Placebo capsules consisting of corn oil

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (2)

Lead Sponsor	Collaborator
Maimonides Medical Center	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in ADHD symptoms.		Up to 16 weeks.	No