Ramelteon for Sleep Initiation Insomnia in Individuals With Panic Disorder Who Are Also on Escitalopram for Anxiety
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ClinicalTrials.gov Identifier: NCT00746239 |
Recruitment Status :
Terminated
(Funding for continuation was not received.)
First Posted : September 3, 2008
Results First Posted : October 15, 2015
Last Update Posted : May 30, 2018
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Sponsor:
Milton S. Hershey Medical Center
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Milton S. Hershey Medical Center
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Tracking Information | ||||
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First Submitted Date ICMJE | September 2, 2008 | |||
First Posted Date ICMJE | September 3, 2008 | |||
Results First Submitted Date ICMJE | June 18, 2015 | |||
Results First Posted Date ICMJE | October 15, 2015 | |||
Last Update Posted Date | May 30, 2018 | |||
Study Start Date ICMJE | August 2008 | |||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Evaluate the Effects of Ramelteon on Sleep Quality in Panic Disorder Patients Who Are Also Treated With Escitalopram. [ Time Frame: 10 weeks ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
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Current Secondary Outcome Measures ICMJE |
Evaluate the Association of Improving Sleep Quality (With Ramelteon) on Improvement in Severity of Panic Disorder/Anxiety. [ Time Frame: 10 weeks ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Ramelteon for Sleep Initiation Insomnia in Individuals With Panic Disorder Who Are Also on Escitalopram for Anxiety | |||
Official Title ICMJE | Ramelteon for Sleep Initiation Insomnia in Panic Disorder Who Are Also on Escitalopram for Anxiety: A Double Blind, Randomized Clinical Trial | |||
Brief Summary | Almost 80% of panic disorder patients report difficulty sleeping. Sleep disturbances in turn may exacerbate underlying anxiety/panic attacks. Moreover, individuals with insomnia (sleep disturbance) are at higher risk of developing a new anxiety disorder. Therefore it is expected that improving sleep quality with medications along with other medications to treat anxiety component of panic disorder might be helpful. However, there is lack of pharmacological studies examining the effects of improving sleep disturbances with medications in panic disorder patients, which is a critical problem for providing optimal care to these patients. The objective of this proposal is to determine the effects of ramelteon (FDA approved for insomnia) on sleep disturbances in Panic disorder patients who are on escitalopram for underlying anxiety. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* 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 | Terminated | |||
Actual Enrollment ICMJE |
11 | |||
Original Estimated Enrollment ICMJE |
24 | |||
Actual Study Completion Date ICMJE | July 2010 | |||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00746239 | |||
Other Study ID Numbers ICMJE | 07-013R | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Milton S. Hershey Medical Center | |||
Study Sponsor ICMJE | Milton S. Hershey Medical Center | |||
Collaborators ICMJE | Takeda Pharmaceuticals North America, Inc. | |||
Investigators ICMJE |
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PRS Account | Milton S. Hershey Medical Center | |||
Verification Date | April 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |