Condition category
Mental and Behavioural Disorders
Date applied
19/12/2002
Date assigned
19/12/2002
Last edited
12/05/2011
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 Peter Raven

ORCID ID

Contact details

Royal Free and University College Medical School
Department of Psychiatry and Behavioural Sciences
Royal Free Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
+44 (0)20 7794 0500
raven@rfhsm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

00/05A

Study information

Scientific title

Acronym

Study hypothesis

The purpose and objectives of the research are to determine whether exogenous melatonin will normalise the sleep-wake cycle in depression and improve mood in depression.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Neurosciences, psychiatry

Intervention

Conventional Rx and either melatonin 5 mg nocte or placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Melatonin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

05/02/2001

Overall trial end date

31/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 - 65
2. Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) diagnosis of major depression (unipolar)
3. Scoring 71 on Beck Depression Inventory (BDI)
4. Waking 2 or more hours than usual

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

72 (36 in each group)

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

05/02/2001

Recruitment end date

31/10/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Free and University College Medical School
London
NW3 2PF
United Kingdom

Sponsor information

Organisation

The Sir Jules Thorn Charitable Trust (UK)

Sponsor details

24 Manchester Square
London
W1U 3TH
United Kingdom
+44 (0)20 7487 5851
julesthorntrust@compuserve.com

Sponsor type

Charity

Website

http://www.julesthorntrust.org.uk/

Funders

Funder type

Charity

Funder name

The Sir Jules Thorn Charitable Trust (UK)

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20195158

Publication citations

  1. Results

    Serfaty MA, Osborne D, Buszewicz MJ, Blizard R, Raven PW, A randomized double-blind placebo-controlled trial of treatment as usual plus exogenous slow-release melatonin (6 mg) or placebo for sleep disturbance and depressed mood., Int Clin Psychopharmacol, 2010, 25, 3, 132-142, doi: 10.1097/YIC.0b013e32832c260b.

Additional files

Editorial Notes