Effect of Omega-3 Fatty Acid on Cortical Function in ADHD

NCT01883817 | Completed Phase 3 Results DMC

• 1 other identifier: 2013-0199
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Disorder

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

• 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

  10 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 10 weeks

Drug: Placebo

DHA Omega-3

EXPERIMENTAL

Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 10 weeks

Drug: DHA Omega-3

Interventions

DHA Omega-3 DRUG

Patients will receive a fixed dose of DHA (1,200 mg/day, 600 mg twice daily) or placebo (corn/soy oil) over 10 weeks

Also known as: Docosahexaenoic acid, Omega 3 Fatty Acids

DHA Omega-3

Placebo DRUG

corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)

Also known as: Inactive drug

Placebo

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Provision of written informed consent/assent
• Ages 5-15 years old
• Meets DSM-IV-TR criteria for ADHD as determined by the KSADS

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead
• DSM Nutritional Products, Inc.: collaborator

Study Sites (1)

University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Docosahexaenoic Acids; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Director Clinical Research Management
• Organization: University of Cincinnati

gayathri.kavikondala@uc.edu

513-558-8621

Study Officials

• Robert K McNamara, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 21, 2013
• Study Start: September 1, 2013
• Primary Completion: March 3, 2017
• Study Completion: March 3, 2017
• Last Updated: March 16, 2022
• Results First Posted: March 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)