Ramelteon for Sleep Initiation Insomnia in Individuals With Panic Disorder Who Are Also on Escitalopram for Anxiety

• ClinicalTrials.gov Identifier: NCT00746239
• Recruitment Status: Terminated
• First Posted: September 3, 2008
• Results First Posted: October 15, 2015
• Last Update Posted: May 30, 2018
• Sponsor: Milton S. Hershey Medical Center
• 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

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
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

Baseline Characteristics

Arm/Group Title		PD Subjects With Either Escitalopram and Placebo OR Ramelteon
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
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

Outcome Measures

1. Primary Outcome

Title	Evaluate the Effects of Ramelteon on Sleep Quality in Panic Disorder Patients Who Are Also Treated With Escitalopram.
Description	[Not Specified]
Time Frame	10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PD Subjects With Either Escitalopram and Placebo OR Ramelteon
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.
Description	[Not Specified]
Time Frame	10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PD Subjects With Either Escitalopram and Placebo OR Ramelteon
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.

Adverse Events

Time Frame	2 years 2 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	PD Subjects With Either Escitalopram and Placebo OR Ramelteon
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	--/--
Serious Adverse Events
	PD Subjects With Either Escitalopram and Placebo OR Ramelteon
	Affected / at Risk (%)
Total	0/11 (0.00%)
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

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

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