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A Study of Patients With Major Depressive Disorder and Residual Apathy

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Duloxetine (Drug); Escitalopram (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

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

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

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

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

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

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

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

Percentage of Participants Who Relapsed During 8 Weeks

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

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

Detailed description: Apathy is reported by up to 30% of patients with major depressive disorder (MDD) and is hypothesized to be a treatment emergent adverse effect associated with selective serotonin reuptake inhibitor medication. While there is currently no consistent method for treating apathy among psychiatrists, it has been proposed that switching MDD patients to antidepressant medications containing both serotonin and norepinephrine, such as duloxetine, may reduce the incidence and severity of apathy in these patients.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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. 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.

Locations and Contacts

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., Durango 34270, Mexico

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., Frac. Hacienda De Las Cruces 82110, Mexico

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., Mexico City 06700, Mexico

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., Moscow 115522, Russian Federation

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., Saint Petersburg 192019, Russian Federation

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., Douliou City 640, Taiwan

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., Kao Hsiung 802, Taiwan

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., Tao-Yuan 333, Taiwan

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., Winnipeg, Manitoba R3P 0N5, Canada

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, Queensland 4053, Australia

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., Spring Hill, Queensland 4000, Australia

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., Glenside, South Australia 5065, Australia

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., Dandenong, Victoria 3175, Australia

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., Frankston, Victoria VIC 3199, Australia

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., Prahran, Victoria 3181, Australia

Additional Information

Starting date: September 2009
Last updated: December 7, 2011

Page last updated: August 20, 2015

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