Back to results

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

Primary Purpose

Panic Disorder, Insomnia

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Placebo and Escitalopram

Ramelteon and Escitalopram

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring insomnia, sleep difficulty, panic disorder, nocturnal panic attacks, anxiety

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Penn State Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00746239

First Posted

September 2, 2008

Last Updated

April 30, 2018

Sponsor

Milton S. Hershey Medical Center

Collaborators

Takeda Pharmaceuticals North America, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00746239

Brief Title

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

Official Title

Ramelteon for Sleep Initiation Insomnia in Panic Disorder Who Are Also on Escitalopram for Anxiety: A Double Blind, Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Terminated

Why Stopped

Funding for continuation was not received.

Study Start Date

August 2008 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Milton S. Hershey Medical Center

Collaborators

Takeda Pharmaceuticals North America, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Panic Disorder, Insomnia

Keywords

insomnia, sleep difficulty, panic disorder, nocturnal panic attacks, anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo and Escitalopram

Intervention Description

Placebo and Escitalopram (5 to 40 mg)

Intervention Type

Drug

Intervention Name(s)

Ramelteon and Escitalopram

Intervention Description

Ramelteon 8 mg and Escitalopram (5-40 mg)

Primary Outcome Measure Information:

Title

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

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ravi Singareddy, MD

Organizational Affiliation

Penn State College of Medicine/Hershey Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Penn State Hershey Medical Center

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.nimh.nih.gov/health/topics/panic-disorder/index.shtml

Description

National Institute of Mental Health Patient information page

URL

http://www.medem.com/MedLB/article_detaillb.cfm?article_ID=ZZZXHSH3DMC&sub_cat=47

Description

American Medical Association Medem links to panic disorder

URL

http://www.nlm.nih.gov/medlineplus/panicdisorder.html

Description

MedlinePlus panic disorder information

Learn more about this trial

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

We'll reach out to this number within 24 hrs