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Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder

Primary Purpose

Insomnia

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Eszopiclone

Placebo

Escitalopram

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Major Depression, Geriatric

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Diagnosis of MDD, HAMD score 20 or greater at screening and baseline, total sleep time less than 6 hours at screening and baseline, ISI 15 or greater at screening and baseline

Exclusion Criteria:

May not use any other psychoactive drugs/psychotropics during study, may not have any type of dementia, may not have any significant/unstable medical problems, no nightshift work permitted, no current seizure disorders/head injuries

Sites / Locations

Lehigh Center for Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Eszopiclone

Placebo

Arm Description

Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg

Drug: Placebo, Drug: Escitalopram 10mg or 20mg

Outcomes

Primary Outcome Measures

Change in total sleep time from baseline to final visit

Secondary Outcome Measures

change in sleep latency from baseline to final visit

Change in HAMD from baseline to final visit

Change in ISI from baseline to final visit

Change in CGI-S, CGI-I from baseline to final visit

labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height

vitals: BP,pulse,temperature,weight,assess AE's/SAE's

Full Information

NCT ID

NCT00813735

First Posted

December 22, 2008

Last Updated

October 2, 2012

Sponsor

Lehigh Center for Clinical Research

Collaborators

Sumitomo Pharma America, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00813735

Brief Title

Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder

Official Title

Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lehigh Center for Clinical Research

Collaborators

Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Research has established the incidence of insomnia increases with age and the possible causes contributing to sleep problems in the elderly are still being explored and debated. Older adults use a disproportionately large share of sleep aids with non-prescription sleep aid use having increased over the past decade. This study is a double blind safety and effectiveness trial examining the response of eszopiclone co-administered with escitalopram for the treatment of insomnia symptoms in geriatric depressed adults with insomnia symptoms.

Detailed Description

This is a double-blind, randomized, placebo-controlled, parallel-group study. There are two groups of subjects with Major Depressive Disorder and insomnia symptoms randomized to treatment either with eszopicone 2mg or placebo daily at bedtime for 14 weeks beginning at visit 2. Also, all subjects receive open label treatment with escitalopram 10 or 20mg daily in the morning. Safety and efficacy is evaluated as well as rating scales and patient sleep diaries.

6. Conditions and Keywords

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

Insomnia

Keywords

Insomnia, Major Depression, Geriatric

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Eszopiclone

Arm Type

Experimental

Arm Description

Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Drug: Placebo, Drug: Escitalopram 10mg or 20mg

Intervention Type

Drug

Intervention Name(s)

Eszopiclone

Other Intervention Name(s)

Escitalopram 10mg or 20mg daily in the AM

Intervention Description

Eszopiclone 2mg daily at bedtime

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Escitalopram 10mg or 20mg daily in the AM

Intervention Description

Placebo daily at bedtime

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Intervention Description

Escitalopram 10mg or 20mg

Primary Outcome Measure Information:

Title

Change in total sleep time from baseline to final visit

Time Frame

from baseline to final visit

Secondary Outcome Measure Information:

Title

change in sleep latency from baseline to final visit

Time Frame

from baseline to final visit

Title

Change in HAMD from baseline to final visit

Time Frame

from baseline to final visit

Title

Change in ISI from baseline to final visit

Time Frame

baseline to final visit

Title

Change in CGI-S, CGI-I from baseline to final visit

Time Frame

baseline to final visit

Title

labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height

Time Frame

visit 1

Title

vitals: BP,pulse,temperature,weight,assess AE's/SAE's

Time Frame

every visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of MDD, HAMD score 20 or greater at screening and baseline, total sleep time less than 6 hours at screening and baseline, ISI 15 or greater at screening and baseline Exclusion Criteria: May not use any other psychoactive drugs/psychotropics during study, may not have any type of dementia, may not have any significant/unstable medical problems, no nightshift work permitted, no current seizure disorders/head injuries

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul K Gross

Organizational Affiliation

Lehigh Center for Clinical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lehigh Center for Clinical Research

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18104

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder

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