N/A Completed N=24 Randomized Treatment

Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia

Source: ClinicalTrials.gov NCT01348542 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcomePrimary: Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months) — 28.95; 38.91 minutes

Summary

The purpose of this study is to evaluate the effect of a 3 month medication trial of Trazodone versus 3 months of Cognitive Behavioral Therapy (CBT) in patients with chronic insomnia.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months)	28.95; 38.91	—
PRIMARY Change in Objective Polysomnography Sleep Duration From Baseline to Follow up (9 Months)	51.78; 32.36	—
PRIMARY Change in Objective Actigraphy Sleep Duration From Baseline to Post Treatment (3 Months)	51.01; -11.73	—
PRIMARY Change in Objective Actigraphy Sleep Duration From Baseline to Follow up (9 Months)	50.35; -7.56	—
SECONDARY Change From Baseline in Subjective Severity of Sleep Disturbance at 3 Months	-12.29; -10.75	—
SECONDARY Change From Baseline in Subjective Severity of Sleep Disturbance at 9 Months	-13.29; -10.38	—

Eligibility Criteria

Inclusion Criteria

Chronic insomnia with duration of more than 1 year
Objective short sleep duration (< 6 hours)
BMI < 39
Ages 30-60
Men & Women

Exclusion Criteria

Major Mental Illness
Substance Abuse/Dependence
Sleep Apnea
Periodic Limb Movement Disorder
Shift Work or circadian disorders
Diabetes
Chronic Renal Failure, Hepatic Insufficiency, Chronic Heart Failure
Current Use of hypnotics or sleep inducing sedative antidepressants

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01348542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.