Attention Deficit Disorder
Conditions
Keywords
ADHD
Brief summary
The study hypothesis is that DHA is more effective than placebo in increasing brain activation and reducing symptoms in psychostimulant-free children with ADHD.
Detailed description
This study aims to determine the effects of 10-week dietary supplementation with the long-chain omega-3 fatty acid docosahexaenoic acid (DHA) or placebo on prefrontal cortical structural and functional connectivity using several neuroimaging techniques: DTI (Diffusion Tensor Imaging), 1H MRS(Proton Magnetic Resonance Spectroscopy), and fMRI (Functional Magnetic Resonance Imaging) in psychostimulant-free children with attention deficit hyperactivity disorder (ADHD). It is postulated that DHA supplements will increase brain activation and reduce ADHD symptomatology.
Interventions
DRUGDHA Omega-3
Patients will receive a fixed dose of DHA (1,200 mg/day, 600 mg twice daily) or placebo (corn/soy oil) over 10 weeks
DRUGPlacebo
corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)
Sponsors
DSM Nutritional Products, Inc.
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Provision of written informed consent/assent * Ages 5-15 years old * Meets DSM-IV-TR criteria for ADHD as determined by the KSADS
Exclusion criteria
* Contraindication to an MRI scan (i.e., braces, claustrophobia) * A history of a major medical (e.g., diabetes) or neurological illness (e.g., epilepsy) * Greater than 1 year outside appropriate age/grade level * A history of intolerance or hypersensitivity to omega-3 fatty acids * Currently taking omega-3 supplements * Not proficient in English language * Any history of a hematological disorder or concomitant use of anticoagulant medications * Personal history of an Axis I psychiatric disorder other than ADHD * Inability to swallow capsules
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attention-Deficit Hyperactivity Disorder Symptom Ratings Using the ADHD Rating Scale (ADHD-RS-IV) | 10 weeks | Attention-Deficit Hyperactivity Disorder Rating Scale Version IV (ADHD-RS-IV) Min score: 0 Max score: 54 Higher score = more severe ADHD symptoms |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 12 weeks
Placebo: corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA) | 14 |
| DHA Omega-3 Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 12 weeks
DHA Omega-3: Patients will receive a fixed dose of DHA (1,200 mg/day, 600 mg twice daily) or placebo (corn/soy oil) over 12 weeks | 16 |
| Total | 30 |
Baseline characteristics
| Characteristic | Placebo | DHA Omega-3 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 16 Participants | 30 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 9 Participants | 16 Participants |
| Region of Enrollment United States | 14 participants | 16 participants | 30 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 16 |
| other Total, other adverse events | 0 / 14 | 0 / 16 |
| serious Total, serious adverse events | 0 / 14 | 0 / 16 |
Outcome results
Primary
Attention-Deficit Hyperactivity Disorder Symptom Ratings Using the ADHD Rating Scale (ADHD-RS-IV)
Attention-Deficit Hyperactivity Disorder Rating Scale Version IV (ADHD-RS-IV) Min score: 0 Max score: 54 Higher score = more severe ADHD symptoms
Time frame: 10 weeks
Population: Adolescents with a current Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision diagnosis of Major Depressive Disorder or Depressive Disorder not otherwise specified, a Childhood Depression Rating Scale-Revised (CDRS-R) Version raw score of \>40, and at least one biological parent with bipolar I disorder.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Attention-Deficit Hyperactivity Disorder Symptom Ratings Using the ADHD Rating Scale (ADHD-RS-IV) | 47.1 score on a scale | Standard Error 8.5 |
| DHA Omega-3 | Attention-Deficit Hyperactivity Disorder Symptom Ratings Using the ADHD Rating Scale (ADHD-RS-IV) | 46.1 score on a scale | Standard Error 6.6 |