| Source of record | UK Trials |
| ISRCTN | ISRCTN82912246 |
| Date ISRCTN assigned | 19/12/2002 |
| Local reference number(s) | 00/05A |
| Public title | Is melatonin a natural sleep promoter and antidepressant? |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Neurosciences, psychiatry |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 05/02/2001 |
| Anticipated end date | 31/10/2003 |
| Status of trial | Completed |
| Target number of participants | 72 (36 in each group) |
| Interventions | Conventional Rx and either melatonin 5 mg nocte or placebo. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | The Sir Jules Thorn Charitable Trust (UK) |
| Sponsor name | The Sir Jules Thorn Charitable Trust (UK) |
| Sponsor details | 24 Manchester Square
London
United Kingdom
W1U 3TH |
| Sponsor telephone | +44 (0)20 7487 5851 |
| Sponsor fax | +44 (0)20 7224 3976 |
| Sponsor email | julesthorntrust@compuserve.com |
| Sponsor website | http://www.julesthorntrust.org.uk/ |
| Contact name | Dr Peter Raven |
| Contact details | Royal Free and University College Medical School
Department of Psychiatry and Behavioural Sciences
Royal Free Campus
Rowland Hill Street
London
United Kingdom
NW3 2PF |
| Contact telephone | +44 (0)20 7794 0500 |
| Contact fax | +44 (0)20 7830 2808 |
| Contact email | raven@rfhsm.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN82912246 |
| Date last extracted from ISRCTN register | 17/04/2008 |
