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TerminatedNCT00746239Updated May 30, 2018Results posted

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

An interventional study of Placebo and Escitalopram and Ramelteon and Escitalopram in Panic Disorder and Insomnia, sponsored by Milton S. Hershey Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-05-30.

Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Treatment

Why this study was terminated
Funding for continuation was not received.
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Panic Disorder
  • Insomnia

Keywords

  • insomnia
  • sleep difficulty
  • panic disorder
  • nocturnal panic attacks
  • anxiety
03

In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 593 are open to participants now.

This study's enrollment of 11 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Clinical diagnosis of panic disorder
    1. Difficulty initiating sleep (subjective sleep latency (SL) of >30 minutes) for at least 3 times per week in the preceding month.

Exclusion criteria

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.
    1. Patients with current psychotic disorder, current bipolar disorder, or substance use disorder (except nicotine dependence) or Subjects with significant suicide risk.
    1. Candidates with known sensitivity to any selective serotonin reuptake inhibitors (SSRI) will be excluded.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. Consumption of greater than 720 mgs. of caffeine daily.
    1. History of shift work (11 PM to 7 AM) in the past 6 months.
    1. 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.
    1. Individuals with personality, behavior, or medical disorders likely to interfere with study participation.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
11 participants (actual)

Study arms

  • Active comparator
    1

    Subjects will be randomly assigned to receive either Ramelteon and Escitalopram OR Placebo and Escitalopram.

    Drug: Ramelteon and Escitalopram

  • Placebo comparator
    2

    Subjects will be randomly assigned to receive either Ramelteon and Escitalopram OR Placebo and Escitalopram.

    Drug: Placebo and Escitalopram

Interventions

  • DrugPlacebo and Escitalopram

    Placebo and Escitalopram (5 to 40 mg)

  • DrugRamelteon and Escitalopram

    Ramelteon 8 mg and Escitalopram (5-40 mg)

06

What researchers measure

Primary outcomes

  1. Evaluate the Effects of Ramelteon on Sleep Quality in Panic Disorder Patients Who Are Also Treated With Escitalopram.

    Time frame: 10 weeks

Secondary outcomes

  1. Evaluate the Association of Improving Sleep Quality (With Ramelteon) on Improvement in Severity of Panic Disorder/Anxiety.

    Time frame: 10 weeks

07

Results

Posted Oct 15, 2015

Participant flow

11 subjects total were enrolled in the study. It was a double blind study, however, the blind was never opened as the study was terminated prematurely due to lack of continued funding. Thus, subjects in each arm are not known. Out of the 11 subjects enrolled, 6 withdrew from the study and 5 completed the study.

Participant flow — Overall Study
MilestonePD Subjects With Either Escitalopram and Placebo OR Ramelteon
Started11
Completed5
Not completed6

Outcome measures

PrimaryEvaluate the Effects of Ramelteon on Sleep Quality in Panic Disorder Patients Who Are Also Treated With Escitalopram.
Time frame:
10 weeks

No measurements were reported for this outcome.

SecondaryEvaluate the Association of Improving Sleep Quality (With Ramelteon) on Improvement in Severity of Panic Disorder/Anxiety.
Time frame:
10 weeks

No measurements were reported for this outcome.

Adverse events

Collected over 2 years 2 months. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PD Subjects With Either Escitalopram and Placebo OR Ramelteon—0/11 (0%)1/11 (9.1%)
Most frequent other events
Most frequent other events
EventPD Subjects With Either Escitalopram and Placebo OR Ramelteon
extreme drowsiness and difficult focussingNervous system disorders1/11

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PD Subjects With Either Escitalopram and Placebo OR Ramelteon
<=18 years0
Between 18 and 65 years11
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)PD Subjects With Either Escitalopram and Placebo OR Ramelteon
Female6
Male5
Region of Enrollment
Region of Enrollment(participants)PD Subjects With Either Escitalopram and Placebo OR Ramelteon
United States11
08

Study locations

1 site
  • Penn State Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00746239
Lead sponsor
Milton S. Hershey Medical Center
Collaborators
Takeda Pharmaceuticals North America, Inc.
Responsible party
Sponsor
First posted
Sep 3, 2008
Start date
Aug 2008
Primary completion
Jul 2010
Completion
Jul 2010
Results posted
Oct 15, 2015
Last update
May 30, 2018

Study contacts

Ravi Singareddy, MD
principal investigator · Penn State College of Medicine/Hershey Medical Center
View the source record on ClinicalTrials.gov ↗

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