Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Milton S. Hershey Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Milton S. Hershey Medical Center
Information provided by:
Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01348542
First received: April 20, 2011
Last updated: May 4, 2011
Last verified: April 2011
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | April 20, 2011 | ||||||||
| Last Updated Date | May 4, 2011 | ||||||||
| Start Date ICMJE | April 2011 | ||||||||
| Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change from Baseline in objective sleep duration at 9 months [ Time Frame: Baseline, 3 months & 9 months ] [ Designated as safety issue: No ] Polysomnography & Actigraphy will be used to measure sleep duration at baseline, post treatment (3 months) and follow-up (9 months). |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01348542 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Change from Baseline in Subjective Severity of Sleep Disturbance & Subjective Sleep Duration at 9 months [ Time Frame: Baseline, 3 months & 9 months ] [ Designated as safety issue: No ] Sleep Diary and subjective questionnaires will be used to measure severity of sleep disturbance and subjective sleep duration at baseline, post treatment (3 months) and follow-up (9 months). |
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia | ||||||||
| Official Title ICMJE | Efficacy of Trazodone vs. Cognitive Behavioral Therapy in Patients With Chronic Insomnia Associated With Objective Short Sleep Duration | ||||||||
| 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. |
||||||||
| Detailed Description | Participants with chronic insomnia associated with objective short sleep duration will be recruited to participate in a 3 month clinical trial on the efficacy of trazodone versus CBT. The primary outcome measure will be objective sleep duration as measured by both actigraphy and polysomnography. The secondary outcome measure will be subjective severity of sleep disturbance and subjective sleep duration. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Insomnia | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 24 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 30 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01348542 | ||||||||
| Other Study ID Numbers ICMJE | 35933 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Alexandros N. Vgontzas, MD, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | ||||||||
| Study Sponsor ICMJE | Milton S. Hershey Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Milton S. Hershey Medical Center | ||||||||
| Verification Date | April 2011 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||