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Trial record 64 of 592 for:    ESCITALOPRAM AND Celexa

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

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ClinicalTrials.gov Identifier: NCT00746239
Recruitment Status : Terminated (Funding for continuation was not received.)
First Posted : September 3, 2008
Results First Posted : October 15, 2015
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE September 2, 2008
First Posted Date  ICMJE September 3, 2008
Results First Submitted Date  ICMJE June 18, 2015
Results First Posted Date  ICMJE October 15, 2015
Last Update Posted Date May 30, 2018
Study Start Date  ICMJE August 2008
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2008)
Evaluate the Effects of Ramelteon on Sleep Quality in Panic Disorder Patients Who Are Also Treated With Escitalopram. [ Time Frame: 10 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00746239 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2008)
Evaluate the Association of Improving Sleep Quality (With Ramelteon) on Improvement in Severity of Panic Disorder/Anxiety. [ Time Frame: 10 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ramelteon for Sleep Initiation Insomnia in Individuals With Panic Disorder Who Are Also on Escitalopram for Anxiety
Official Title  ICMJE Ramelteon for Sleep Initiation Insomnia in Panic Disorder Who Are Also on Escitalopram for Anxiety: A Double Blind, Randomized Clinical Trial
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Panic Disorder
  • Insomnia
Intervention  ICMJE
  • Drug: Placebo and Escitalopram
    Placebo and Escitalopram (5 to 40 mg)
  • Drug: Ramelteon and Escitalopram
    Ramelteon 8 mg and Escitalopram (5-40 mg)
Study Arms  ICMJE
  • Active Comparator: 1
    Subjects will be randomly assigned to receive either Ramelteon and Escitalopram OR Placebo and Escitalopram.
    Intervention: Drug: Ramelteon and Escitalopram
  • Placebo Comparator: 2
    Subjects will be randomly assigned to receive either Ramelteon and Escitalopram OR Placebo and Escitalopram.
    Intervention: Drug: Placebo and Escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 30, 2010)
11
Original Estimated Enrollment  ICMJE
 (submitted: September 2, 2008)
24
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00746239
Other Study ID Numbers  ICMJE 07-013R
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Takeda Pharmaceuticals North America, Inc.
Investigators  ICMJE
Principal Investigator: Ravi Singareddy, MD Penn State College of Medicine/Hershey Medical Center
PRS Account Milton S. Hershey Medical Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP