N/A
N=24
Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia
Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT01348542 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months) — 28.95; 38.91 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trazodone (Drug); Cognitive Behavioral Therapy (Behavioral)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Jun 2018
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 | — |
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.
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
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.