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NCT00782080

Efficacy and Safety of St. John´s Wort/Valerian Extract (Sedariston Concentrate) Versus Placebo in Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD)

Completed Phase 3 Last updated 12 March 2014
What this trial tests

Phase 3 trial testing Sedariston in ADHD in 155 participants. Completed in 1 June 2010.

Timeline
1 July 2008
Primary endpoint
1 March 2010
1 June 2010

Quick facts

Lead sponsorProf. Huss
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment155
Start date1 July 2008
Primary completion1 March 2010
Estimated completion1 June 2010
Sites5 locations across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Prof. Huss

Who can join

Adults 6 to 17, any sex, with ADHD. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD. Study Design: * Randomized * Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) * Placebo Control * Parallel Assignment

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Enhancing of cerebral Abeta clearance by modulation of ABC transporter expression: a review of experimental approaches.
    Loeffler DA. · · 2024 · cited 2× · PMID 38872626 · DOI 10.3389/fnagi.2024.1368200

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Currently open trials in the same condition.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing