Efficacy Study of Polyunsaturated Fatty Acids in Children and Adolescents With Attention Deficit/ Hyperactivity Disorder

NCT01340690 | Terminated Phase 3 DMC

• 1 other identifier: PAD-EA-10-01-067
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 5

Brief Summary

This study will determine the nutritional efficacy of Polyunsaturated Fatty Acids (PUFAs) in combination with zinc and magnesium, in children and adolescents diagnosed with Attention Deficit/ Hyperactivity Disorder (ADHD). The nutritional efficacy has to be proven in agreement with the German "Verordnung über Diätetische Lebensmittel (DiätV)" and the corresponding European Directive 1999/21/EC. This objective is reached by performing a placebo-controlled supplementation study with a main efficacy criterion which is also being used in pivotal studies of stimulant and non-stimulant drugs, i.e. the treatment differences between final visit and baseline in the Attention Deficit Hyperactivity Disorder Rating Scale, Parent Version IV (ADHDRS-IV).

Conditions

ADHD

Keywords

ADHD; children; adolescents; Polyunsaturated Fatty Acids; ADHDRS - IV

Outcome Measures

Primary Outcomes (1)

• ADHDRS - IV

  The primary outcome measure for efficacy will be the absolute change in the ADHDRS total score between baseline and day 84 of randomized treatment.

  Difference in total score between baseline and end of study, an expected average of 84 days

Secondary Outcomes (6)

• Barkley´s Side Effects Rating Scale

  Baseline and each visit, monthly, an expected average of 84 days in total

• Montgomery-Åsberg-Depression Rating Scale (MADRS)

  Baseline and each visit, monthly, an expected average of 84 days in total

• Continuous Performance Test (CPT)

  change from Baseline to end of treatment, an expected average of 84 days

• Nutrition protocol

  baseline

• Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P)

  change from Baseline to end of treatment, an expected average of 84 days

Study Arms (2)

ω-3 fatty acids suspension

ACTIVE COMPARATOR

2 bags of Esprico(R) suspension each day. Each 4ml suspension bag includes 400mg eicosapentaenoic acid (EPA), 40mg docosahexaenoic acid (DHA), 5.4 mg gamma-linolenic acid (GLA), 80 mg magnesium, 5 mg zinc and consists of linseed oil, xylitol, sea fish oil with high portion of omega-3-acids, magnesium citrate, vegetable oil, orange flavour, evening primrose oil, zink gluconate, soya lecithin, citric acid, acesulfame k (E950)

Dietary Supplement: ω-3 fatty acids suspension

placebo suspension

PLACEBO COMPARATOR

2 bags of Esprico (R) placebo suspension. Includes no ω-3 fatty acids, no ω-6 fatty acids, no magnesium and no zinc, but other vegetable oils, orange flavor, etc.

Dietary Supplement: placebo suspension

Interventions

ω-3 fatty acids suspension DIETARY_SUPPLEMENT

2 bags of Esprico(R) suspension given orally once daily in the morning for 84 days

Also known as: Esprico(R) suspension, 2 verum to 1 placebo

ω-3 fatty acids suspension

placebo suspension DIETARY_SUPPLEMENT

suspension to mimic verum Esprico (R) suspension. 2 bags of Esprico(R) placebo suspension given orally once daily in the morning for 84 days

placebo suspension

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written Informed Consent by parents and patients (separately for age groups 6 - 11 years and 12 - 17 years)
• Children and adolescents of both gender in the age group between 6 and 17 years
• Confirmed diagnosis of ADHD by semi-structured clinical interview Kiddie Schedule for Affective Disorders and Schizophrenia for school-age children (K-SADS)
• ADHDRS-IV-Parent Version (18-Item-Scale): Investigator Administered and Scored ≥24
• Sufficient knowledge of the German language

You may not qualify if:

• Known hypersensitivity against components of either the verum or placebo food
• All serious internal diseases
• All severe psychiatric diseases except oppositional defiant disorders
• Current intake of the following medication: antidepressants and other psychotropic medication
• Recent intake of ω-3 fatty acids supplementation
• Indication for hospitalization
• Suicidality (including suicidal thoughts)
• intelligence quotient \< 70
• Previous medication with stimulants within 4 weeks
• Placement in an institution on official or judicial ruling
• Lack of willingness to store and transmit pseudonym data according to German regulations
• Parallel participation in another trial, or less than 4 weeks ago
• Patients foreseeable requiring a primary medication with methylphenidate during the study period of 12 weeks

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• Engelhard Arzneimittel GmbH & Co.KG: collaborator

Study Sites (5)

DRK Fachklinik für Kinder- und Jugendpsychiatrie, Psychotherapie, Psychosomatik

Bad Neuenahr, D 53474, Germany

Location

Charité - Universitätsmedizin Berlin, CVK Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters

Berlin, D 13353, Germany

Location

University Medicine Mainz

Mainz, D 55131, Germany

Location

Kinderzentrum Maulbronn gGmbH

Maulbronn, D 75433, Germany

Location

Johanniter - Zentrum für Kinder- und Jugendpsychiatrie Neuwied

Neuwied, D 56564, Germany

Location

Related Publications (2)

• Schuchardt JP, Huss M, Stauss-Grabo M, Hahn A. Significance of long-chain polyunsaturated fatty acids (PUFAs) for the development and behaviour of children. Eur J Pediatr. 2010 Feb;169(2):149-64. doi: 10.1007/s00431-009-1035-8. Epub 2009 Aug 12.

  PMID: 19672626 BACKGROUND

• Huss M, Volp A, Stauss-Grabo M. Supplementation of polyunsaturated fatty acids, magnesium and zinc in children seeking medical advice for attention-deficit/hyperactivity problems - an observational cohort study. Lipids Health Dis. 2010 Sep 24;9:105. doi: 10.1186/1476-511X-9-105.

  PMID: 20868469 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Suspensions

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Michael Huss, Prof. Dr.

  University Medicine, Mainz, Dep. of Child and Adolescent Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The verum "nutrional supplementation" is completely masked and an appropriate Placebo is provided. Up to know, none of the above mentioned is unblinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Michael Huss, Prof. Dr.

Model Details: We use the dietary supplementation like a medication and performed the study like a phase 3 medication study, because the dietary supplementation (verum) is available as special preparation in drug stores.

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 22, 2011
• Study Start: March 8, 2011
• Primary Completion: March 31, 2016
• Study Completion: March 1, 2017
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

DE (5)