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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00746239
• Date of registration: 02/09/2008
• Prospective Registration: No
• Primary sponsor: Milton S. Hershey Medical Center
• Public title: Ramelteon for Sleep Initiation Insomnia in Individuals With Panic Disorder Who Are Also on Escitalopram for Anxiety
• Scientific title: Ramelteon for Sleep Initiation Insomnia in Panic Disorder Who Are Also on Escitalopram for Anxiety: A Double Blind, Randomized Clinical Trial
• Date of first enrolment: August 2008
• Target sample size: 11
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00746239
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Ravi Singareddy, MD
• Affiliation: Penn State College of Medicine/Hershey Medical Center

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Insomnia

Panic Disorder

Intervention(s)

Drug: Ramelteon and Escitalopram

Drug: Placebo and Escitalopram

Primary Outcome(s)

Evaluate the Effects of Ramelteon on Sleep Quality in Panic Disorder Patients Who Are Also Treated With Escitalopram. [Time Frame: 10 weeks]

Secondary Outcome(s)

Evaluate the Association of Improving Sleep Quality (With Ramelteon) on Improvement in Severity of Panic Disorder/Anxiety. [Time Frame: 10 weeks]

Secondary ID(s)

07-013R

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Takeda Pharmaceuticals North America, Inc.

Results

• Results available: Yes
• Date Posted: 15/10/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00746239