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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Maimonides Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Maimonides Medical Center
ClinicalTrials.gov Identifier:
NCT01233856
First received: November 1, 2010
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Attention-Deficit/Hyperactivity Disorder
Drug: Lovaza
Dietary Supplement: Placebo (corn oil).

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Omega-3 Fatty Acids as an Adjunctive Therapy for Stimulants in Children With ADHD

Resource links provided by NLM:


Further study details as provided by Maimonides Medical Center:

Primary Outcome Measures:
  • Improvement in ADHD symptoms. [ Time Frame: Up to 16 weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stimulants plus Omega-3 F.A (Lovaza) Drug: Lovaza
2000mg daily.
Placebo Comparator: Stimulants plus placebo (corn oil). Dietary Supplement: Placebo (corn oil).
Placebo capsules consisting of corn oil

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233856

Locations
United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Jose M Torrijos, MD    718-283-8828    jtorrijos@maimonidesmed.org   
Sponsors and Collaborators
Maimonides Medical Center
GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT01233856     History of Changes
Other Study ID Numbers: 09/06/VA05
Study First Received: November 1, 2010
Last Updated: August 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Maimonides Medical Center:
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014