Is melatonin a natural sleep promoter and antidepressant?
| ISRCTN | ISRCTN82912246 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82912246 |
| Protocol serial number | 00/05A |
| Sponsor | The Sir Jules Thorn Charitable Trust (UK) |
| Funder | The Sir Jules Thorn Charitable Trust (UK) |
- Submission date
- 19/12/2002
- Registration date
- 19/12/2002
- Last edited
- 12/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Peter Raven
Scientific
Scientific
Royal Free and University College Medical School
Department of Psychiatry and Behavioural Sciences
Royal Free Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
| Phone | +44 (0)20 7794 0500 |
|---|---|
| raven@rfhsm.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neurosciences, psychiatry |
| Intervention | Conventional Rx and either melatonin 5 mg nocte or placebo. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Melatonin |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 72 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 05/02/2001 |
| Date of final enrolment | 31/10/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal Free and University College Medical School
London
NW3 2PF
United Kingdom
NW3 2PF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2010 | Yes | No |
