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

This study has been terminated.
(Funding for continuation was not received.)
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Ravi Singareddy, Penn State University
ClinicalTrials.gov Identifier:
NCT00746239
First received: September 2, 2008
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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 Intervention
Panic Disorder
Insomnia
Drug: Placebo and Escitalopram
Drug: Ramelteon and Escitalopram

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Evaluate the effects of ramelteon on sleep quality in panic disorder patients who are also treated with escitalopram. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the association of improving sleep quality (with ramelteon) on improvement in severity of panic disorder/anxiety. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: August 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746239

Locations
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
Takeda Pharmaceuticals North America, Inc.
Investigators
Principal Investigator: Ravi Singareddy, MD Penn State College of Medicine/Hershey Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Ravi Singareddy, Associate Proffesor, Penn State University
ClinicalTrials.gov Identifier: NCT00746239     History of Changes
Other Study ID Numbers: 07-013R
Study First Received: September 2, 2008
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
insomnia
sleep difficulty
panic disorder
nocturnal panic attacks
anxiety

Additional relevant MeSH terms:
Disease
Panic Disorder
Anxiety Disorders
Mental Disorders
Pathologic Processes
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014