Serotonin sensitivity in insomnia: a placebo-controlled crossover study of sleep after 5HT2 blockade in primary insomnia
| ISRCTN | ISRCTN38174888 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38174888 |
| Secondary identifying numbers | N0038183440 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 21/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sue Wilson
Scientific
Scientific
University of Bristol
Dorothy Hodgkin Building
Whitson Street
Bristol
BS1 3NY
United Kingdom
| Phone | +44 0117 331 3172 |
|---|---|
| sue.wilson@bris.ac.uk |
Study information
| Study design | Randomised double-blind placebo-controlled crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Serotonin sensitivity in insomnia: a placebo-controlled crossover study of sleep after 5HT2 blockade in primary insomnia |
| Study objectives | Does Trazodone improve sleep in primary insomnia? |
| Ethics approval(s) | Bath Research Ethics Committee, 21/04/2006, REC ref: 06/Q2001/32. |
| Health condition(s) or problem(s) studied | Nervous System Diseases: Primary insomnia |
| Intervention | Trazodone vs placebo. Overnight sleep patterns recorded and compared, after either placebo or trazodone 100mg. Each patient has screening visit and 2 overnight sleep recordings at home a week apart, plus an end-of study visit. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Trazodone |
| Primary outcome measure | Sleep efficiency: % Total Sleep Time / Staging Time. |
| Secondary outcome measures | 1. Daily symptom report (DSR) 2. Total sleep time (TST) 3. Number of awakenings 4. Wake Time After Sleep Onset (WASO) 5. Time spent in stages 1 to 4 and rapid eye movement (REM), %TST spent in each stage 6. REM onset latency 7. Sleep onset Latency (SOL), slow wave activity 8. Leeds Sleep Evaluation Questionnaire. |
| Overall study start date | 28/04/2006 |
| Completion date | 31/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 12 insomnia patients |
| Total final enrolment | 12 |
| Key inclusion criteria | 1. Adults referred to Psychopharmacology Unit Clinic 7, Bristol Royal Infirmary with psycho-physiological insomnia 2. Complaint of poor sleep with daytime consequences |
| Key exclusion criteria | 1. Taking psychotropic medication 2. Total sleep time (subjective) < 6.5 hours 3. Current psychiatric disorder |
| Date of first enrolment | 28/04/2006 |
| Date of final enrolment | 31/01/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Bristol
Bristol
BS1 3NY
United Kingdom
BS1 3NY
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Avon and Wiltshire Mental Health Partnership NHS Trust (UK)
No information available
AWP Partnership Mental Health NHS Trust R&D Project grant
No information available
NHS R&D Support Funding
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? |
|---|---|---|---|---|---|
| Abstract results | conference abstract | 01/09/2009 | 21/06/2019 | No | No |
| Other publications | review article | 01/09/2011 | 21/06/2019 | Yes | No |
Editorial Notes
21/06/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
29/04/2016: No publications found, verifying study status with principal investigator
