MedTrace Logo

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

NCT01778647 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-12-14

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Stimulants plus Lovaza

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

DRUG

Stimulants plus placebo

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.

Sponsors & Collaborators

  • Antonios Likourezos

    lead OTHER

Principal Investigators

  • Kathleen Malloy, MD · Maimonides Medical Center

  • Juan D Pedraza, MD · Maimonides Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01778647 on ClinicalTrials.gov