Condition category
Mental and Behavioural Disorders
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
17/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kristiaan B van der Heijden

ORCID ID

Contact details

Transvaalstraat 86-c
Amsterdam
1092 HP
Netherlands
+31 (0)61 986 4148
kbvanderheijden@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR69

Study information

Scientific title

Acronym

MACI

Study hypothesis

To assess the efficacy and safety of melatonin treatment in children with attention deficit hyperactivity disorder (ADHD) and chronic sleep onset insomnia.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, double blind, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Attention deficit hyperactivity disorder, chronic sleep onset insomnia

Intervention

Melatonin (3 mg when body weight less than 40 kg; 6 mg greater than 40 kg) or placebo during 1 month at 19:00 hours.

Intervention type

Drug

Phase

Not Specified

Drug names

Melatonin

Primary outcome measures

1. Sleep onset, latency, and total sleep duration as estimated with actigraphy and sleep log
2. Salivary dim light melatonin onset (DLMO).

Measurements take place at baseline, in the third week of a placebo-controlled treatment period.

Secondary outcome measures

1. Computerised measures of sustained attention and response inhibition
2. Severity of ADHD symptoms
3. Quality of life
4. Side effects

Overall trial start date

01/11/2001

Overall trial end date

01/11/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. ADHD
2. Chronic sleep onset insomnia
3. Aged 6 - 12 years, boys/girls
4. Intelligence quotient (IQ) greater than 80

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

110

Participant exclusion criteria

1. Epilepsy
2. Chronic pain
3. Renal/hepatic diseases
4. Pervasive developmental disorder
5. Used stimulants, melatotin, neuroleptics, benzodiazepines, clonidin, antidepressants, hypnotics, or beta blockers within four weeks before enrolment

Recruitment start date

01/11/2001

Recruitment end date

01/11/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Transvaalstraat 86-c
Amsterdam
1092 HP
Netherlands

Sponsor information

Organisation

University Maastricht (The Netherlands)

Sponsor details

CAPHRI Research Institute
PO Box 616
Maastricht
6200 MD
Netherlands

Sponsor type

University/education

Website

http://www.caphri.nl/

Funders

Funder type

Research organisation

Funder name

Foundation De Drie Lichten (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Maarten Kapelle Foundation (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Epilepsy Centre Kempenhaeghe Heeze (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hospital Gelderse Vallei Ede (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Academic Medical Centre (AMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes