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
Protocol serial number	N0038183440
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funders	Avon and Wiltshire Mental Health Partnership NHS Trust (UK), AWP Partnership Mental Health NHS Trust R&D Project grant, NHS R&D Support Funding

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

University of Bristol
Dorothy Hodgkin Building
Whitson Street
Bristol
BS1 3NY
United Kingdom

Phone	+44 0117 331 3172
Email	sue.wilson@bris.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled crossover study
Secondary study design	Randomised cross over trial
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Trazodone
Primary outcome measure(s)	Sleep efficiency: % Total Sleep Time / Staging Time.
Key secondary outcome measure(s)	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.
Completion date	31/01/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	12
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

United Kingdom
England

Study participating centre

University of Bristol

Bristol
BS1 3NY
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

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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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