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

This study has been terminated.
(Co-Investigators left the Institution.)
Sponsor:
Information provided by (Responsible Party):
Maimonides Medical Center
ClinicalTrials.gov Identifier:
NCT01778647
First received: September 30, 2010
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

Multiple forms of Omega-3 Fatty acids have been used to investigate the role of this food supplement in children with 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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Dietary Supplement: Stimulants plus Lovaza (drug)
Drug: Stimulants plus Placebo (instead of Lovaza)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:
  • Conners RATING SCALE (PASRENTS AND TEACHERS) [ Time Frame: 16 WEEKS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CGI SCALE [ Time Frame: 16 WEEKS ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: December 2009
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stimulants plus Lovaza
Usual dose of stimulant plus Lovaza (prescription Omega-3 fatty acids) at a Dose of 1800 mg daily.
Dietary Supplement: Stimulants plus Lovaza (drug)
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
Other Name: Lovaza plus stimulants
Placebo Comparator: Stimulants plus PLacebo
Usual dose of stimulants plus placebo(corn oil), which will be given to the patients by MMC's pharmacy.
Drug: Stimulants plus Placebo (instead of Lovaza)
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.
Other Name: Sugar pill plus Stimulants

Detailed Description:

A total of 30-150 patients or more between the ages of 6 and 15 years old with diagnosis of ADHD according to the DSM-IV and on current treatment with stimulants recruited from CAOS-MMC 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 Conner's 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).

The patients will be divided in 2 groups. One group of 15 children will be randomized to continue taking the usual dose of stimulants plus placebo(corn oil), which will be given to the patients by MMC's pharmacy.

A second group of 15 patients will be randomized to receive the usual dose of stimulant plus Lovaza (prescription Omega-3 fatty acids) at a Dose of 1800 mg daily.

Both groups will be initially treated for a period of 8 weeks. The patients will be re-evaluated by the 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.

The ratings of the Conner's rating scales filled for each patient will be analyzed and compared to the initial evaluation after week 8. The evaluators will also do a CGI score for every 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 the 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 study will be supported by GSK. This pharmaceutical company will provide the capsules and the placebo.

  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 6 to 15 years old 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 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): Forster 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

  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: NCT01778647

Locations
United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Maimonides Medical Center
Investigators
Principal Investigator: Kathleen Malloy, MD Maimonides Medical Center
Study Director: Juan D Pedraza, MD Maimonides Medical Center
  More Information

No publications provided

Responsible Party: Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT01778647     History of Changes
Other Study ID Numbers: LVZ113607
Study First Received: September 30, 2010
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Maimonides Medical Center:
ADHD
Omega- 3 Fatty acids
CGI
Conners rating scale
Stimulants

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

ClinicalTrials.gov processed this record on October 21, 2014