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
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
-
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.