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Sponsored by: |
Penn State University |
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Information provided by: | Penn State University |
ClinicalTrials.gov Identifier: | NCT00746239 |
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 |
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Panic Disorder Insomnia |
Drug: Placebo and Escitalopram Drug: Ramelteon and Escitalopram |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Official Title: | Ramelteon for Sleep Initiation Insomnia in Panic Disorder Who Are Also on Escitalopram for Anxiety: A Double Blind, Randomized Clinical Trial |
Estimated Enrollment: | 24 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Subjects will be randomly assigned to receive either Ramelteon and Escitalopram OR Placebo and Escitalopram.
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Drug: Ramelteon and Escitalopram
Ramelteon 8 mg and Escitalopram (5-40 mg)
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2: Placebo Comparator
Subjects will be randomly assigned to receive either Ramelteon and Escitalopram OR Placebo and Escitalopram.
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Drug: Placebo and Escitalopram
Placebo and Escitalopram (5 to 40 mg)
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christine Schaeffer, RN, CCRC | (717) 531 3779 | cschaeffer@hmc.psu.edu |
United States, Pennsylvania | |
Penn State Hershey Medical Center | Recruiting |
Hershey, Pennsylvania, United States, 17033 | |
Contact: Christine Schaeffer, RN 717-531-3779 cschaeffer@hmc.psu.edu | |
Contact: Ravi Singareddy, MD (717) 531 2947 rsingareddy@hmc.psu.edu | |
Principal Investigator: Ravi Singareddy, MD | |
Sub-Investigator: Edward Bixler, PhD | |
Sub-Investigator: Anoop Karippot, MD | |
Sub-Investigator: Alexandros Vgontzas, MD |
Principal Investigator: | Ravi Singareddy, MD | Penn State College of Medicine/Hershey Medical Center |
Responsible Party: | Penn State College of Medicine/ Hershey Medical Center ( Ravi Singareddy ) |
Study ID Numbers: | 07-013R |
Study First Received: | September 2, 2008 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00746239 |
Health Authority: | United States: Institutional Review Board |
insomnia sleep difficulty panic disorder nocturnal panic attacks anxiety |
Sleep Initiation and Maintenance Disorders Panic Disorder Anxiety Disorders Mental Disorders Dyssomnias |
Sleep Disorders Dexetimide Citalopram Serotonin Sleep Disorders, Intrinsic |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |