Condition category
Nervous System Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
29/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

29/04/2016: No publications found, verifying study status with principal investigator