NCT01348542

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 5, 2011

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 21, 2019

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

7.2 years

First QC Date

April 20, 2011

Results QC Date

May 28, 2019

Last Update Submit

February 14, 2020

Conditions

Insomnia

Keywords

Chronic InsomniaShort Sleep DurationTrazodoneCognitive Behavioral TherapyEfficacy

Outcome Measures

Primary Outcomes (4)

  • Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months)

    Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and post treatment (3 months)

    Baseline to Post Treatment (3 months)

  • Change in Objective Polysomnography Sleep Duration From Baseline to Follow up (9 Months)

    Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and follow up (9 months)

    Baseline to follow up (9 months)

  • Change in Objective Actigraphy Sleep Duration From Baseline to Post Treatment (3 Months)

    Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and Post Treatment (3 months)

    Baseline to Post Treatment (3 months)

  • Change in Objective Actigraphy Sleep Duration From Baseline to Follow up (9 Months)

    Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and follow up (9 months)

    Baseline to follow up (9 months)

Secondary Outcomes (2)

  • Change From Baseline in Subjective Severity of Sleep Disturbance at 3 Months

    Baseline to Post Treatment (3 months)

  • Change From Baseline in Subjective Severity of Sleep Disturbance at 9 Months

    Baseline to follow up (9 months)

Study Arms (2)

Trazodone

ACTIVE COMPARATOR
Drug: Trazodone

Cognitive Behavioral Therapy

ACTIVE COMPARATOR
Behavioral: Cognitive Behavioral Therapy

Interventions

TrazodoneDRUG

50 mg once a day, for 3 months

Trazodone
Cognitive Behavioral TherapyBEHAVIORAL

The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis.

Cognitive Behavioral Therapy

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (8)

  • Vgontzas AN, Liao D, Pejovic S, Calhoun S, Karataraki M, Basta M, Fernandez-Mendoza J, Bixler EO. Insomnia with short sleep duration and mortality: the Penn State cohort. Sleep. 2010 Sep;33(9):1159-64. doi: 10.1093/sleep/33.9.1159.

    PMID: 20857861BACKGROUND

  • Vgontzas AN, Liao D, Pejovic S, Calhoun S, Karataraki M, Bixler EO. Insomnia with objective short sleep duration is associated with type 2 diabetes: A population-based study. Diabetes Care. 2009 Nov;32(11):1980-5. doi: 10.2337/dc09-0284. Epub 2009 Jul 29.

    PMID: 19641160BACKGROUND

  • Vgontzas AN, Liao D, Bixler EO, Chrousos GP, Vela-Bueno A. Insomnia with objective short sleep duration is associated with a high risk for hypertension. Sleep. 2009 Apr;32(4):491-7. doi: 10.1093/sleep/32.4.491.

    PMID: 19413143BACKGROUND

  • Vgontzas AN, Bixler EO, Lin HM, Prolo P, Mastorakos G, Vela-Bueno A, Kales A, Chrousos GP. Chronic insomnia is associated with nyctohemeral activation of the hypothalamic-pituitary-adrenal axis: clinical implications. J Clin Endocrinol Metab. 2001 Aug;86(8):3787-94. doi: 10.1210/jcem.86.8.7778.

    PMID: 11502812BACKGROUND

  • Fernandez-Mendoza J, Calhoun S, Bixler EO, Pejovic S, Karataraki M, Liao D, Vela-Bueno A, Ramos-Platon MJ, Sauder KA, Vgontzas AN. Insomnia with objective short sleep duration is associated with deficits in neuropsychological performance: a general population study. Sleep. 2010 Apr;33(4):459-65. doi: 10.1093/sleep/33.4.459.

    PMID: 20394314BACKGROUND

  • Fernandez-Mendoza J, Calhoun SL, Bixler EO, Karataraki M, Liao D, Vela-Bueno A, Jose Ramos-Platon M, Sauder KA, Basta M, Vgontzas AN. Sleep misperception and chronic insomnia in the general population: role of objective sleep duration and psychological profiles. Psychosom Med. 2011 Jan;73(1):88-97. doi: 10.1097/PSY.0b013e3181fe365a. Epub 2010 Oct 26.

    PMID: 20978224BACKGROUND

  • Li Y, Vgontzas AN, Fernandez-Mendoza J, Fang J, Puzino K, Bixler EO. Effect of trazodone versus cognitive-behavioural treatment on high- and slow-frequency activity during non-rapid eye movement sleep in chronic insomnia: A pilot, randomized clinical trial. J Sleep Res. 2021 Oct;30(5):e13324. doi: 10.1111/jsr.13324. Epub 2021 Mar 5.

    PMID: 33675113DERIVED

  • Vgontzas AN, Puzino K, Fernandez-Mendoza J, Krishnamurthy VB, Basta M, Bixler EO. Effects of trazodone versus cognitive behavioral therapy in the insomnia with short sleep duration phenotype: a preliminary study. J Clin Sleep Med. 2020 Dec 15;16(12):2009-2019. doi: 10.5664/jcsm.8740.

    PMID: 32780015DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

TrazodoneCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyridonesPyridinesBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Alexandros Vgontzas
Organization
Penn State University College of Medicine
vgontzas@pennstatehealth.psu.edu
717 531-7278

Study Officials

  • Alexandros N Vgontzas, MD

    Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 20, 2011

First Posted

May 5, 2011

Study Start

April 1, 2011

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

February 25, 2020

Results First Posted

June 21, 2019

Record last verified: 2020-02

Locations

US(1)