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ISRCTN
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ISRCTN38174888
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ClinicalTrials.gov identifier
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Public title
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Serotonin sensitivity in insomnia: a placebo-controlled crossover study of sleep after 5HT2 blockade in primary insomnia
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0038183440
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Study hypothesis
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Does Trazodone improve sleep in primary insomnia?
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Ethics approval
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Added September 2008: Approved 21/04/2006 by Bath Research Ethics Committee, REC number 06/Q2001/32.
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Study design
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Randomised, double-blind, placebo-controlled crossover study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Nervous System Diseases: Primary insomnia
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Participants - inclusion criteria
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1. Adults referred to Psychopharmacology Unit Clinic 7, Bristol Royal Infirmary with psycho-physiological insomnia
2. Complaint of poor sleep with daytime consequences
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Participants - exclusion criteria
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1. Taking psychotropic medication
2. Total sleep time (subjective) < 6.5 hours
3. Current psychiatric disorder
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Anticipated start date
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28/04/2006
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Anticipated end date
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31/01/2009
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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12 insomnia patients
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Interventions
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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.
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Primary outcome measure(s)
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Sleep efficiency: % Total Sleep Time / Staging Time.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Avon and Wiltshire Mental Health Partnership NHS Trust (UK)
AWP Partnership Mental Health NHS Trust R&D Project grant
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Dr
Sue
Wilson
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Address
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University of Bristol
Dorothy Hodgkin Building
Whitson Street
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City/town
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Bristol
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Zip/Postcode
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BS1 3NY
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Country
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United Kingdom
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Tel
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+44 0117 331 3172
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Fax
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+44 0117 331 3180
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Email
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sue.wilson@bris.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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28/09/2007
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Last edited
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10/09/2008
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Date ISRCTN assigned
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28/09/2007
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