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

NCT ID: NCT00746239

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-07-31

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.

Conditions

Panic Disorder; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Subjects will be randomly assigned to receive either Ramelteon and Escitalopram OR Placebo and Escitalopram.

Group Type: ACTIVE_COMPARATOR

Ramelteon and Escitalopram

Intervention Type: DRUG

Ramelteon 8 mg and Escitalopram (5-40 mg)

2

Subjects will be randomly assigned to receive either Ramelteon and Escitalopram OR Placebo and Escitalopram.

Group Type: PLACEBO_COMPARATOR

Placebo and Escitalopram

Intervention Type: DRUG

Placebo and Escitalopram (5 to 40 mg)

Interventions

Placebo and Escitalopram

Placebo and Escitalopram (5 to 40 mg)

Intervention Type: DRUG

Ramelteon and Escitalopram

Ramelteon 8 mg and Escitalopram (5-40 mg)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1) Clinical diagnosis of panic disorder
• 2) 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.
• 2) Patients with current psychotic disorder, current bipolar disorder, or substance use disorder (except nicotine dependence) or Subjects with significant suicide risk.
• 3) Candidates with known sensitivity to any selective serotonin reuptake inhibitors (SSRI) will be excluded.
• 4) 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.
• 5) 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.
• 6) 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.
• 7) 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.
• 8) Consumption of greater than 720 mgs. of caffeine daily.
• 9) History of shift work (11 PM to 7 AM) in the past 6 months.
• 10) 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.
• 11) Individuals with personality, behavior, or medical disorders likely to interfere with study participation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda Pharmaceuticals North America, Inc.

INDUSTRY

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ravi Singareddy, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine/Hershey Medical Center

Locations

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Related Links

http://www.nimh.nih.gov/health/topics/panic-disorder/index.shtml

National Institute of Mental Health Patient information page

http://www.medem.com/MedLB/article_detaillb.cfm?article_ID=ZZZXHSH3DMC&sub_cat=47

American Medical Association Medem links to panic disorder

http://www.nlm.nih.gov/medlineplus/panicdisorder.html

MedlinePlus panic disorder information

Other Identifiers

07-013R

Identifier Type: -

Identifier Source: org_study_id