Is melatonin a natural sleep promoter and antidepressant?
| ISRCTN | ISRCTN82912246 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82912246 |
| Secondary identifying numbers | 00/05A |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Melatonin |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 05/02/2001 |
| Completion date | 31/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 72 (36 in each group) |
| 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
- England
- United Kingdom
Study participating centre
Royal Free and University College Medical School
London
NW3 2PF
United Kingdom
NW3 2PF
United Kingdom
Sponsor information
The Sir Jules Thorn Charitable Trust (UK)
Charity
Charity
24 Manchester Square
London
W1U 3TH
United Kingdom
| Phone | +44 (0)20 7487 5851 |
|---|---|
| julesthorntrust@compuserve.com | |
| Website | http://www.julesthorntrust.org.uk/ |
"ROR" |
https://ror.org/03ntprd85 |
Funders
Funder type
Charity
The Sir Jules Thorn Charitable Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
