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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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Conditions |
Panic Disorder Insomnia |
Interventions |
Drug: Placebo and Escitalopram Drug: Ramelteon and Escitalopram |
Enrollment | 11 |
Participant Flow
Recruitment Details | 11 subjects total were enrolled in the study. It was a double blind study, however, the blind was never opened as the study was terminated prematurely due to lack of continued funding. Thus, subjects in each arm are not known. Out of the 11 subjects enrolled, 6 withdrew from the study and 5 completed the study. |
Pre-assignment Details |
Arm/Group Title | PD Subjects With Either Escitalopram and Placebo OR Ramelteon |
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Subjects were randomly assigned to receive either Ramelteon 8 mg and Escitalopram (5-40 mg) OR Placebo and Escitalopram (5-40 mg). However, as the blind was never opened, we are combining all subjects in one group for presenting in this record. |
Period Title: Overall Study | |
Started | 11 |
Completed | 5 [1] |
Not Completed | 6 |
[1]
11 subjects total were enrolled - 6 withdrew from study and 5 competed
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Baseline Characteristics
Arm/Group Title | PD Subjects With Either Escitalopram and Placebo OR Ramelteon | |
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Panic disorder subjects who were on Escitalopram (5-40 mg) received either Ramelteon 8 mg OR Placebo. As the study was terminated prematurely, the blind was never opened. Thus, it is not known as to how many were in each arm. As a result we are combining all subjects in one group for presenting in this record. | |
Overall Number of Baseline Participants | 11 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 11 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
11 100.0%
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>=65 years |
0 0.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 11 participants | |
Female |
6 54.5%
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Male |
5 45.5%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 11 participants |
11 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Ravi Singareddy |
Organization: | Penn State Hershey Medical Center |
Phone: | 717-531-0040 |
EMail: | rsingare@gmail.com |
Responsible Party: | Milton S. Hershey Medical Center |
ClinicalTrials.gov Identifier: | NCT00746239 |
Other Study ID Numbers: |
07-013R |
First Submitted: | September 2, 2008 |
First Posted: | September 3, 2008 |
Results First Submitted: | June 18, 2015 |
Results First Posted: | October 15, 2015 |
Last Update Posted: | May 30, 2018 |