Ramelteon for Sleep Initiation Insomnia in Individuals With Panic Disorder Who Are Also on Escitalopram for Anxiety
| Status: | Terminated |
|---|---|
| Conditions: | Insomnia Sleep Studies, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 6/1/2018 |
| Start Date: | August 2008 |
| End Date: | July 2010 |
Ramelteon for Sleep Initiation Insomnia in Panic Disorder Who Are Also on Escitalopram for Anxiety: A Double Blind, Randomized Clinical Trial
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.
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.
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.
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