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

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00746239
• Collaborator: Takeda Pharmaceuticals North America, Inc. (Industry)
• Enrollment: 11
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Panic Disorder; Insomnia	Drug: Placebo and Escitalopram; Drug: Ramelteon and Escitalopram	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Ramelteon for Sleep Initiation Insomnia in Panic Disorder Who Are Also on Escitalopram for Anxiety: A Double Blind, Randomized Clinical Trial
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Subjects will be randomly assigned to receive either Ramelteon and Escitalopram OR Placebo and Escitalopram.	Drug: Ramelteon and Escitalopram; Ramelteon 8 mg and Escitalopram (5-40 mg)
Placebo Comparator: 2 Subjects will be randomly assigned to receive either Ramelteon and Escitalopram OR Placebo and Escitalopram.	Drug: Placebo and Escitalopram; Placebo and Escitalopram (5 to 40 mg)

Outcome Measures

Primary Outcome Measures

1. Evaluate the Effects of Ramelteon on Sleep Quality in Panic Disorder Patients Who Are Also Treated With Escitalopram. [10 weeks]

Secondary Outcome Measures

1. Evaluate the Association of Improving Sleep Quality (With Ramelteon) on Improvement in Severity of Panic Disorder/Anxiety. [10 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Clinical diagnosis of panic disorder
• 1. Difficulty initiating sleep (subjective sleep latency (SL) of >30 minutes) for at least 3 times per week in the preceding month.

Exclusion Criteria:

• 1)Patients meeting DSM-IV criteria (as determined by MINI) for a current anxiety disorder (other than panic disorder), or current major depressive disorder that is considered by the investigator to be primary (i.e., causing a higher degree of distress or impairment than panic disorder)., Patients with past history of DSM-IV anxiety disorders or depressive disorder will not be excluded.

• 1. Patients with current psychotic disorder, current bipolar disorder, or substance use disorder (except nicotine dependence) or Subjects with significant suicide risk.
• 1. Candidates with known sensitivity to any selective serotonin reuptake inhibitors (SSRI) will be excluded.
• 1. CNS diseases: Candidates with seizure disorder (other than febrile seizure in early childhood), a history of other neurological disorder, and head trauma will be excluded.
• 1. Cardiovascular and respiratory diseases: Candidates with hypertension (systolic

130; diastolic > 85), arrhythmias, coronary artery disease, cardiac pacemakers, COPD, asthma, and other pulmonary diseases will be excluded.

• 1. Primary sleep disorders: Candidates with breathing related sleep disorder, restless leg syndrome, circadian rhythm sleep disorders, narcolepsy, and other major primary sleep disorders will be excluded.
• 1. Systemic diseases: Candidates with other medical problems, such as endocrinopathies, renal or hepatic failure, autoimmune diseases involving the CNS, obesity (BMI > 30 kg/m2), or a history of pheochromocytoma will not be eligible.
• 1. Consumption of greater than 720 mgs. of caffeine daily.
• 1. History of shift work (11 PM to 7 AM) in the past 6 months.
• 1. Reproductive status: Women candidates who are pregnant (based on urine test) are not eligible. Women of child bearing age will be on birth control methods during the study period.
• 1. Individuals with personality, behavior, or medical disorders likely to interfere with study participation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn State Hershey Medical Center	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

• Milton S. Hershey Medical Center
• Takeda Pharmaceuticals North America, Inc.

Investigators

• Principal Investigator: Ravi Singareddy, MD, Penn State College of Medicine/Hershey Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• National Institute of Mental Health Patient information page
• American Medical Association Medem links to panic disorder
• MedlinePlus panic disorder information

Publications

None provided.

• Responsible Party: Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT00746239
• Other Study ID Numbers: 07-013R
• First Posted: Sep 3, 2008
• Last Update Posted: May 30, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by Milton S. Hershey Medical Center: insomnia; sleep difficulty; panic disorder; nocturnal panic attacks; anxiety
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Disease; Panic Disorder; Dexetimide; Citalopram

Study Results

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.

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
NOT COMPLETED	6

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 Participants	11
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	11 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	6 54.5%
Male	5 45.5%
Region of Enrollment (participants) [Number]
United States	11 100%

Outcome Measures

1. Primary Outcome

Title	Evaluate the Effects of Ramelteon on Sleep Quality in Panic Disorder Patients Who Are Also Treated With Escitalopram.
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
Measure Participants	0

2. Secondary Outcome

Title	Evaluate the Association of Improving Sleep Quality (With Ramelteon) on Improvement in Severity of Panic Disorder/Anxiety.
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
Measure Participants	0

Adverse Events

Time Frame	2 years 2 months
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	PD Subjects With Either Escitalopram and Placebo OR Ramelteon
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Other (Not Including Serious) Adverse Events
	PD Subjects With Either Escitalopram and Placebo OR Ramelteon
	Affected / at Risk (%)	# Events
Total	1/11 (9.1%)
Nervous system disorders
extreme drowsiness and difficult focussing	1/11 (9.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.