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Trial record 2 of 536 for:    ESCITALOPRAM AND Disorders

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
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Milton S. Hershey Medical Center

Study Type Interventional
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
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
Hide Arm/Group Description 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
Arm/Group Title PD Subjects With Either Escitalopram and Placebo OR Ramelteon
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
6
  54.5%
Male
5
  45.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Evaluate the Effects of Ramelteon on Sleep Quality in Panic Disorder Patients Who Are Also Treated With Escitalopram.
Hide Description [Not Specified]
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PD Subjects With Either Escitalopram and Placebo OR Ramelteon
Hide Arm/Group Description:
11 subjects enrolled- 6 withdrew from study/the blind was never opened as the study was terminated prematurely for lack of continued funding- the data for outcome measures was never collected/compiled/analyzed
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Evaluate the Association of Improving Sleep Quality (With Ramelteon) on Improvement in Severity of Panic Disorder/Anxiety.
Hide Description [Not Specified]
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PD Subjects With Either Escitalopram and Placebo OR Ramelteon
Hide Arm/Group Description:
11 subjects enrolled- 6 withdrew from study/the blind was never opened as the study was terminated prematurely for lack of continued funding- the data for outcome measures was never collected/compiled/analyzed
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 2 years 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PD Subjects With Either Escitalopram and Placebo OR Ramelteon
Hide Arm/Group Description

Panic disorder subjects who were on Escitalopram received either Escitalopram OR Placebo - as the study 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 not combining all in one group for presenting in this record.

Ramelteon and Escitalopram: Ramelteon 8 mg and Escitalopram (5-40 mg)

All-Cause Mortality
PD Subjects With Either Escitalopram and Placebo OR Ramelteon
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PD Subjects With Either Escitalopram and Placebo OR Ramelteon
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
PD Subjects With Either Escitalopram and Placebo OR Ramelteon
Affected / at Risk (%)
Total   1/11 (9.09%) 
Nervous system disorders   
extreme drowsiness and difficult focussing *  1/11 (9.09%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ravi Singareddy
Organization: Penn State Hershey Medical Center
Phone: 717-531-0040
EMail: rsingare@gmail.com
Layout table for additonal information
Responsible Party: Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00746239     History of Changes
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