Status:
TERMINATED
Ramelteon for Sleep Initiation Insomnia in Individuals With Panic Disorder Who Are Also on Escitalopram for Anxiety
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Panic Disorder
Insomnia
Eligibility:
All Genders
18-50 years
Phase:
NA
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) ar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00746239
Start Date
August 1 2008
End Date
July 1 2010
Last Update
May 30 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033