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:
Penn State University
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
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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
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:
|
Anxiety Disorders Panic Disorder Sleep Initiation and Maintenance Disorders Mental Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 16, 2013