Serotonin sensitivity in insomnia: a placebo-controlled crossover study of sleep after 5HT2 blockade in primary insomnia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38174888

Enrollment

Registered

2007-09-28

Start date

2006-04-28

Completion date

Unknown

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nervous System Diseases: Primary insomnia Nervous System Diseases Primary insomnia

Interventions

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 hom

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Taking psychotropic medication 2. Total sleep time (subjective) < 6.5 hours 3. Current psychiatric disorder

Design outcomes

Primary

Measure	Time frame
Sleep efficiency: % Total Sleep Time / Staging Time.	—

Secondary

Measure	Time frame
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.	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026