title: A Randomized Controlled Trial Investigating the Effects of a Special Extract of Bacopa monnieri (CDRI 08) on Hyperactivity and Inattention in Male Children and Adolescents: BACHI Study Protocol (ANZCTRN12612000827831).
abstract: Clinical diagnoses of Attention Deficit Hyperactivity Disorder (ADHD) and the use of prescription medications for its treatment have increased in recent years. Current treatments may involve the administration of amphetamine-type substances, a treatment path many parents are apprehensive to take. Therefore, alternative pharmacological treatments are required. Few nutritional or pharmacological alternatives that reduce ADHD associated symptoms (hyperactivity and inattention) have been subjected to rigorous clinical trials. Bacopa monnieri is a perennial creeping herb. CDRI 08 is a special extract of Bacopa monnieri which has been subjected to hundreds of scientific studies and has been shown in human randomized controlled trials (RCTs) to improve memory, attention, and mood. It is hypothesised that chronic administration of CDRI 08 will improve attention, concentration and behaviour in children with high levels of hyperactivity and/or inattention. This paper reports the protocol for the first 16-week, randomized, placebo-controlled, double-blind, parallel groups trial examining the efficacy and safety of CDRI 08 in male children aged 6-14 years with high levels of inattention and hyperactivity. The primary outcome variable will be the level of hyperactivity and inattention measured by the Conners' Parent Rating Scale (CPRS). Secondary outcome variables include cognition, mood, sleep, and EEG.
  
  
  BACKGROUND
  Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000827831.
authors.affiliation: Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn 3122, Australia. jkean@swin.edu.au.
authors.forename: James D
authors.initials: JD
authors.lastname: Kean
authors.affiliation: Swinburne Babylab, Swinburne University of Technology, Hawthorn 3122, Australia. jkaufman@swin.edu.au.
authors.forename: Jordy
authors.initials: J
authors.lastname: Kaufman
authors.affiliation: Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn 3122, Australia. jlomas@swin.edu.au.
authors.forename: Justine
authors.initials: J
authors.lastname: Lomas
authors.affiliation: Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn 3122, Australia. agoh@swin.edu.
authors.forename: Antionette
authors.initials: A
authors.lastname: Goh
authors.affiliation: Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn 3122, Australia. dwhite@swin.edu.au.
authors.forename: David
authors.initials: D
authors.lastname: White
authors.affiliation: Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn 3122, Australia. dsimpson@swin.edu.au.
authors.forename: David
authors.initials: D
authors.lastname: Simpson
authors.affiliation: Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn 3122, Australia. ascholey@swin.edu.au.
authors.forename: Andrew
authors.initials: A
authors.lastname: Scholey
authors.affiliation: Central Drug Research Institute, Lucknow 226001, India. hemant1943@gmail.com.
authors.forename: Hemant
authors.initials: H
authors.lastname: Singh
authors.affiliation: Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn 3122, Australia. jsarris@unimelb.edu.au.|Department of Psychiatry, University of Melbourne, Parkville 3010, Australia. jsarris@unimelb.edu.au.
authors.forename: Jerome
authors.initials: J
authors.lastname: Sarris
authors.affiliation: Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn 3122, Australia. az@naturalpowermeds.com.|NaturalPowerMeds Consulting SL, Barcelona 08003, Spain. az@naturalpowermeds.com.
authors.forename: Andrea
authors.initials: A
authors.lastname: Zangara
authors.affiliation: Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn 3122, Australia. cstough@swin.edu.au.
authors.forename: Con
authors.initials: C
authors.lastname: Stough
mesh_terms: D000293:Adolescent; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D034681:Bacopa / Q000737:chemistry*; D002648:Child; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D010936:Plant Extracts / Q000737:chemistry / Q000627:therapeutic use*
chemical_list: D010936:Plant Extracts
keywords: ADHD; CDRI 08; RCT; bacopa monnieri; cognition; hyperactivity; inattention