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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00985504

Registration number

NCT00985504

Ethics application status

Date submitted

25/09/2009

Date registered

28/09/2009

Date last updated

13/12/2011

Titles & IDs

Public title

A Study of Patients With Major Depressive Disorder and Residual Apathy

Scientific title

A Phase 4, 8-week, Double-blind, Randomized Study Comparing Switching to Duloxetine or Escitalopram in Patients With Major Depressive Disorder and Residual Apathy in the Absence of Depressed Mood

Secondary ID [1]

F1J-CR-HMGM

Secondary ID [2]

13018

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Major Depressive Disorder

Condition category

Condition code

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - Duloxetine
Treatment: Drugs - Escitalopram

Experimental: Duloxetine -

Active comparator: Escitalopram -

Treatment: Drugs: Duloxetine
60-120 milligrams (mg) taken once daily (QD) by mouth (po) for 8 weeks; with option for additional 2 weeks.

Treatment: Drugs: Escitalopram
10-20 mg taken QD po for 8 weeks; with option for additional 2 weeks.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Change From Baseline in the Apathy Evaluation Scale - Clinician Rated Version (AES-C) Total Score at Week 8

Timepoint [1]

Baseline, 8 weeks

Secondary outcome [1]

Change From Baseline in the Apathy Evaluation Scale-Clinician Rated Version (AES-C) Subscale Scores at Week 8

Timepoint [1]

Baseline, 8 weeks

Secondary outcome [2]

Change From Baseline in the Rothschild Scale for Antidepressant Tachyphylaxis (RSAT) Total and Individual Item Scores at Week 8

Timepoint [2]

Baseline, 8 weeks

Secondary outcome [3]

Patient's Global Impressions of Improvement Scale (PGI-I) Rating Scale Score at Week 8

Timepoint [3]

8 weeks

Secondary outcome [4]

Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Rating Scale at Week 8

Timepoint [4]

Baseline, 8 weeks

Secondary outcome [5]

Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Item 8 (Inability to Feel) at Week 8

Timepoint [5]

Baseline, 8 weeks

Secondary outcome [6]

Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total and Item Scores at Week 8

Timepoint [6]

Baseline, 8 weeks

Secondary outcome [7]

Change From Baseline in the Sheehan Disability Scale (SDS) Total and Individual Scores at Week 8

Timepoint [7]

Baseline, 8 weeks

Secondary outcome [8]

Percentage of Participants Who Relapsed During 8 Weeks

Timepoint [8]

Baseline through 8 weeks

Secondary outcome [9]

Number of Days From Baseline to Relapse as Defined by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score =16 During 8 Weeks

Timepoint [9]

Baseline through 8 weeks

Secondary outcome [10]

Percentage of Participants Who Discontinue Due to Lack of Efficacy During 8 Weeks

Timepoint [10]

Baseline through 8 weeks

Eligibility

Key inclusion criteria

* Have received treatment with an SSRI (escitalopram, sertraline, paroxetine, or citalopram) for major depressive disorder
* Females of child-bearing potential to test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control
* Apathy Evaluation Scale - Clinician Rated Version (AES-C) total score >30 at screening and randomization.
* Montgomery-Asberg Depression Rating Scale (MADRS) total score =15 and Item 1 (apparent sadness) score of <2 at screening and randomization.
* Have a level of understanding sufficient to provide informed consent and to communicate with the investigators, study coordinator, and site personnel.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device
* Have previously completed or withdrawn from this study or any other study investigating duloxetine.
* Have had previous lack of response to an adequate trial of duloxetine within the past 12 months or escitalopram at any time.
* Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), diagnosis of mania, bipolar disorder, treatment resistant depression or psychosis; or current suicide risk
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(DSM-IV-TR),substance abuse or dependence within the 6 months
* Presence of an Axis II disorder
* Monoamine oxidase inhibitor (MAOI) treatment within 14 days prior to randomization or the potential need to use an MAOI during the study
* Positive urine drug screen for any substance of abuse or excluded medication.
* Are pregnant or breast-feeding.
* Serious medical illness, requires hospitalization during the study
* Have uncontrolled narrow-angle glaucoma.
* Have acute liver injury or severe cirrhosis
* Abnormal thyroid stimulating hormone (TSH) concentration
* Amphetamines, dopaminergic medications or modafinil within 14 days prior to randomization or potential need to use such medications during the study or within 14 days of discontinuation of study drug.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/09/2009

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/12/2010

Sample size

Target

Accrual to date

Final

483

Recruitment in Australia

Recruitment state(s)

QLD,SA,VIC

Recruitment hospital [1]

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Everton Park

Recruitment hospital [2]

Recruitment hospital [3]

Recruitment hospital [4]

Recruitment hospital [5]

Recruitment hospital [6]

Recruitment postcode(s) [1]

4053 - Everton Park

Recruitment postcode(s) [2]

4000 - Spring Hill

Recruitment postcode(s) [3]

5065 - Glenside

Recruitment postcode(s) [4]

3175 - Dandenong

Recruitment postcode(s) [5]

VIC 3199 - Frankston

Recruitment postcode(s) [6]

3181 - Prahran

Recruitment outside Australia

Country [1]

Canada

State/province [1]

Manitoba

Country [2]

Mexico

State/province [2]

Durango

Country [3]

Mexico

State/province [3]

Frac. Hacienda De Las Cruces

Country [4]

Mexico

State/province [4]

Mexico City

Country [5]

Russian Federation

State/province [5]

Moscow

Country [6]

Russian Federation

State/province [6]

Saint Petersburg

Country [7]

Taiwan

State/province [7]

Douliou City

Country [8]

Taiwan

State/province [8]

Kao Hsiung

Country [9]

Taiwan

State/province [9]

Tao-Yuan

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Eli Lilly and Company

Address

Country

Other collaborator category [1]

Commercial sector/industry

Name [1]

Boehringer Ingelheim

Address [1]

Country [1]

Ethics approval

Ethics application status

Summary

Brief summary

The purpose of this study is to provide a comparison of the apathy, depression, and functional outcomes associated with switching to duloxetine or escitalopram in patients who have previously responded to treatment with a selective serotonin reuptake inhibitor (SSRI) for major depressive disorder and who have residual apathy in the absence of depressed mood.

Trial website

https://clinicaltrials.gov/study/NCT00985504

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Address

Eli Lilly and Company

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00985504

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00985504