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

Tracking Information

• First Submitted Date: September 2, 2008
• First Posted Date: September 3, 2008
• Results First Submitted Date: June 18, 2015
• Results First Posted Date: October 15, 2015
• Last Update Posted Date: May 30, 2018
• Study Start Date: August 2008
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 2, 2008): Evaluate the Effects of Ramelteon on Sleep Quality in Panic Disorder Patients Who Are Also Treated With Escitalopram. [ Time Frame: 10 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: September 2, 2008): Evaluate the Association of Improving Sleep Quality (With Ramelteon) on Improvement in Severity of Panic Disorder/Anxiety. [ Time Frame: 10 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ramelteon for Sleep Initiation Insomnia in Individuals With Panic Disorder Who Are Also on Escitalopram for Anxiety
• Official Title: Ramelteon for Sleep Initiation Insomnia in Panic Disorder Who Are Also on Escitalopram for Anxiety: A Double Blind, Randomized Clinical Trial
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Panic Disorder
• Insomnia

Intervention

• Drug: Placebo and Escitalopram
  Placebo and Escitalopram (5 to 40 mg)
• Drug: Ramelteon and Escitalopram
  Ramelteon 8 mg and Escitalopram (5-40 mg)

Study Arms

• Active Comparator: 1
  Subjects will be randomly assigned to receive either Ramelteon and Escitalopram OR Placebo and Escitalopram.
  Intervention: Drug: Ramelteon and Escitalopram
• Placebo Comparator: 2
  Subjects will be randomly assigned to receive either Ramelteon and Escitalopram OR Placebo and Escitalopram.
  Intervention: Drug: Placebo and Escitalopram

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: March 30, 2010): 11
• Original Estimated Enrollment (submitted: September 2, 2008): 24
• Actual Study Completion Date: July 2010
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00746239
• Other Study ID Numbers: 07-013R
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Milton S. Hershey Medical Center
• Study Sponsor: Milton S. Hershey Medical Center
• Collaborators: Takeda Pharmaceuticals North America, Inc.

Investigators

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

• PRS Account: Milton S. Hershey Medical Center
• Verification Date: April 2018