Contact information
Type
Scientific
Primary contact
Dr Sue Wilson
ORCID ID
Contact details
University of Bristol
Dorothy Hodgkin Building
Whitson Street
Bristol
BS1 3NY
United Kingdom
+44 0117 331 3172
sue.wilson@bris.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0038183440
Study information
Scientific title
Serotonin sensitivity in insomnia: a placebo-controlled crossover study of sleep after 5HT2 blockade in primary insomnia
Acronym
Study hypothesis
Does Trazodone improve sleep in primary insomnia?
Ethics approval
Bath Research Ethics Committee, 21/04/2006, REC ref: 06/Q2001/32.
Study design
Randomised double-blind placebo-controlled crossover study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
28/04/2006
Overall trial end date
31/01/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
12 insomnia patients
Total final enrolment
12
Participant exclusion criteria
1. Taking psychotropic medication
2. Total sleep time (subjective) < 6.5 hours
3. Current psychiatric disorder
Recruitment start date
28/04/2006
Recruitment end date
31/01/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Bristol
Bristol
BS1 3NY
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Avon and Wiltshire Mental Health Partnership NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
AWP Partnership Mental Health NHS Trust R&D Project grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 conference abstract in: https://doi.org/10.1016/S0924-977X(09)70593-0 (added 21/06/2019)
2011 review article in: https://www.ncbi.nlm.nih.gov/pubmed/21490119 (added 21/06/2019)