Insomnia, Panic Disorder
Conditions
Keywords
insomnia, sleep difficulty, panic disorder, nocturnal panic attacks, anxiety
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.
Interventions
DRUGRamelteon and Escitalopram
Ramelteon 8 mg and Escitalopram (5-40 mg)
DRUGPlacebo and Escitalopram
Placebo and Escitalopram (5 to 40 mg)
Sponsors
Takeda Pharmaceuticals North America, Inc.
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the Effects of Ramelteon on Sleep Quality in Panic Disorder Patients Who Are Also Treated With Escitalopram. | 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the Association of Improving Sleep Quality (With Ramelteon) on Improvement in Severity of Panic Disorder/Anxiety. | 10 weeks |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| PD Subjects With Either Escitalopram and Placebo OR Ramelteon Panic disorder subjects who were on Escitalopram (5-40 mg) received either Ramelteon 8 mg OR Placebo. As the study was terminated prematurely, the blind was never opened. Thus, it is not known as to how many were in each arm. As a result we are combining all subjects in one group for presenting in this record. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | PD Subjects With Either Escitalopram and Placebo OR Ramelteon |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Evaluate the Effects of Ramelteon on Sleep Quality in Panic Disorder Patients Who Are Also Treated With Escitalopram.
Time frame: 10 weeks
Secondary
Evaluate the Association of Improving Sleep Quality (With Ramelteon) on Improvement in Severity of Panic Disorder/Anxiety.
Time frame: 10 weeks