Omega-3 Fatty Acids as an Adjunctive Therapy for Treatment in Attention-Deficit Hyperactivity Disorder (ADHD)
|ClinicalTrials.gov Identifier: NCT01233856|
Recruitment Status : Unknown
Verified August 2011 by Maimonides Medical Center.
Recruitment status was: Recruiting
First Posted : November 3, 2010
Last Update Posted : August 26, 2011
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.
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.
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 or disease||Intervention/treatment|
|Attention-Deficit/Hyperactivity Disorder||Drug: Lovaza Dietary Supplement: Placebo (corn oil).|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Health Services Research|
|Official Title:||Omega-3 Fatty Acids as an Adjunctive Therapy for Stimulants in Children With ADHD|
|Study Start Date :||June 2009|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||June 2012|
|Active Comparator: Stimulants plus Omega-3 F.A (Lovaza)||
|Placebo Comparator: Stimulants plus placebo (corn oil).||
Dietary Supplement: Placebo (corn oil).
Placebo capsules consisting of corn oil
- Improvement in ADHD symptoms. [ Time Frame: Up to 16 weeks. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233856
|United States, New York|
|Maimonides Medical Center||Recruiting|
|Brooklyn, New York, United States, 11219|
|Contact: Jose M Torrijos, MD 718-283-8828 email@example.com|