A Study of Patients With Major Depressive Disorder and Residual Apathy


Tracking Information

Start Date  ICMJESeptember 2009
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: September 25, 2009)		Mean change from baseline to 8 weeks endpoint in Apathy Evaluation Scale - Clinician rated version (AES-C) total score [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00985504 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: September 25, 2009)
  • Mean change from baseline in scores of the Apathy Evaluation Scale-Clinician rated version (AES-C) subscale scores [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline in scores of the Rothschild Scale for Antidepressant Tachyphylaxis (RSAT) total and individual item scores [ Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline in scores of the Patient Global Impression of Improvement (PGI-Improvement) Rating Scale [ Time Frame: 1 week, 2 weeks, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline in scores of the Clinical Global Impression of Severity (CGI-Severity) Rating Scale [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline in scores of the Montgomery-Asberg Depression Rating Scale (MADRS) total score and item 8 (inability to feel) [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline to 8 weeks endpoint in scores of the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) total and individual item scores [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Mean changes from baseline to 8 weeks endpoint in scores of the Sheehan Disability Scale (SDS) total and individual item scores [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients who relapse as defined by MADRS total score >16 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Time to relapse as defined by MADRS total score >16 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of patients who discontinue due to lack of efficacy in the investigators opinion [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks, 8 weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of Patients With Major Depressive Disorder and Residual Apathy
Official Title  ICMJEA 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
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.

Detailed Description

Apathy is reported by up to 30% of patients with major depressive disorder 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.

Study PhasePhase IV
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEMajor Depressive Disorder
Intervention  ICMJE
  • Drug: Duloxetine
    60-120mg taken once daily by mouth for 8 weeks; with option for additional 2 weeks
    Other Names:
    • Cymbalta
    • LY248686
  • Drug: Escitalopram
    10-20mg taken once daily by mouth for 8 weeks; with option for additional 2 weeks
Study Arms / Comparison Groups
  • Duloxetine: Experimental
    Intervention: Drug: Duloxetine
  • Escitalopram: Active Comparator
    Intervention: Drug: Escitalopram

Recruitment Information

Estimated Enrollment  ICMJE500
Estimated Completion DateDecember 2010
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • AES-C total score >30 at screening and randomization.
  • 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.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
Location Countries  ICMJEAustralia,   Brazil,   Canada,   China,   Italy,   Korea, Republic of,   Mexico,   Russian Federation,   Taiwan

Administrative Information

NCT ID  ICMJENCT00985504
Responsible PartyChief Medical Officer, Eli Lilly
Study ID Numbers  ICMJE13018, F1J-CR-HMGM
Study Sponsor  ICMJEEli Lilly and Company
Collaborators  ICMJEBoehringer Ingelheim Pharmaceuticals
Investigators  ICMJE
Study Director: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)Eli Lilly and Company
Information Provided ByEli Lilly and Company