Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia
This study is ongoing, but not recruiting participants.
Sponsor:
Massachusetts General Hospital
Collaborators:
Sunovion
Beth Israel Deaconess Medical Center
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00833547
First received: January 29, 2009
Last updated: July 19, 2011
Last verified: July 2011
| Tracking Information | |||||
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| First Received Date ICMJE | January 29, 2009 | ||||
| Last Updated Date | July 19, 2011 | ||||
| Start Date ICMJE | September 2006 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Sleep-dependent motor skill learning [ Time Frame: Day 4 of study ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00833547 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Sleep architecture and sleep latency as measured by polysomnography [ Time Frame: during four nights in GCRC ] [ Designated as safety issue: No ] | ||||
| 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 | Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia | ||||
| Official Title ICMJE | Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia | ||||
| Brief Summary | This study will determine whether eszopiclone will normalize sleep patterns and restore sleep-dependent enhancement of motor skill learning in patients with schizophrenia. The investigators will compare subjects taking a placebo to those taking 3 mg of eszopiclone with regard to: sleep architecture and sleep latency as measured by actigraphy and polysomnography and sleep-dependent motor skill learning. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
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| Condition ICMJE | Schizophrenia | ||||
| Intervention ICMJE | Drug: eszopiclone
3 mg of eszopiclone at bedtime on two consecutive nights
Other Name: Lunesta |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 45 | ||||
| Estimated Completion Date | September 2012 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00833547 | ||||
| Other Study ID Numbers ICMJE | Sepracor051 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dara S. Manoach, Massachusetts General Hospital | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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