Impact of nefazodone on sleep architecture in insomnia
| ISRCTN | ISRCTN84604889 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84604889 |
| Protocol serial number | N0038104044 |
| Sponsor | Department of Health (UK) |
| Funder | Avon and Wiltshire Mental Health Partnership NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 28/09/2018
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jane Hicks
Scientific
Scientific
Cottham House
Cottham Hill
Bristol
BS16 1JB
United Kingdom
| Phone | +44 (0)117 9 427 373 |
|---|---|
| abc@123.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Impact of nefazodone on sleep architecture in insomnia |
| Study objectives | Does nefazodone improve sleep in insomnia? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Mental and Behavioural Disorders: Insomnia |
| Intervention | 1. Nefazodone 2. Placebo This is a double blind placebo-controlled crossover study to look at the effects of nefazodone on sleep in insomnia. Patients will be given a two week washout from any psychotropic medication and then randomised to take either 100 mg of nefazodone or placebo for 2 weeks with a 2 week washout, then cross over to the treatment. At the end of the each 2 weeks their overnight sleep will be measured at home by polysomnography and they will be asked to fill in questionnaires about their sleep. Objective and subjective sleep measures will be compared in subject between the two treatment periods. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Objective Total Sleep Time |
| Key secondary outcome measure(s) |
All other measures of objective and subjective sleep |
| Completion date | 30/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Key inclusion criteria | Patients aged 18 to 65 meeting criteria for insomnia (International Classification of Sleep Disorders) and without: use of other psychotropic drugs, allergy to nefazodone, current or past severe mental illness or substance abuse, current depressive illness. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2001 |
| Date of final enrolment | 30/09/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cottham House
Bristol
BS16 1JB
United Kingdom
BS16 1JB
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 |
Editorial Notes
28/09/2018: No publications found, all search options exhausted, study status unverified.
