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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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F1J-CR-HMGM
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Secondary ID [2]
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13018
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in the Apathy Evaluation Scale - Clinician Rated Version (AES-C) Total Score at Week 8
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Assessment method [1]
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The AES-C is a validated 18-item instrument used to assess cognitive, behavioral, emotional and other symptoms of apathy. Clinicians rate each item based on verbal and nonverbal information provided by the participant. Item scores range from 1 (not at all characteristic) to 4 (a lot characteristic). Total scores range from 18 to 72 where higher derived scores indicate more severe apathy. The Least Squares (LS) Mean Value was calculated from a mixed model repeated measures (MMRM) model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.
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Timepoint [1]
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Baseline, 8 weeks
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Secondary outcome [1]
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Change From Baseline in the Apathy Evaluation Scale-Clinician Rated Version (AES-C) Subscale Scores at Week 8
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Assessment method [1]
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AES-C subscales separately assess participants' intensity of cognitive, behavioral, emotional, and other apathy symptoms with individual item scores of 1 (not at all characteristic) to 4 (a lot characteristic). Subtotal score ranges for the subscales are: 8-32 (cognitive), 5-20 (behavioral), 2-8 (emotional), and 3-12 for other (display of personal insight, initiative and motivation). Higher subscale scores indicate greater illness severity. The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.
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Timepoint [1]
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Baseline, 8 weeks
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Secondary outcome [2]
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Change From Baseline in the Rothschild Scale for Antidepressant Tachyphylaxis (RSAT) Total and Individual Item Scores at Week 8
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Assessment method [2]
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RSAT assesses symptoms of apathy or decreased motivation among depressed participants who have achieved symptomatic remission with antidepressant treatment and consists of 6 self-report items assessing energy level, motivation and interest, cognitive functioning, weight gain, sleep and sexual functioning, as well as affect. Each item score ranges from 0 to 4 with total scores ranging from 0 to 28. Higher scores indicate greater disease severity. LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.
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Timepoint [2]
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Baseline, 8 weeks
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Secondary outcome [3]
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Patient's Global Impressions of Improvement Scale (PGI-I) Rating Scale Score at Week 8
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Assessment method [3]
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The PGI-I is a scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, and treatment*visit.
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Timepoint [3]
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8 weeks
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Secondary outcome [4]
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Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Rating Scale at Week 8
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Assessment method [4]
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The CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.
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Timepoint [4]
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Baseline, 8 weeks
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Secondary outcome [5]
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Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Item 8 (Inability to Feel) at Week 8
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Assessment method [5]
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MADRS is a rating scale for severity of depressive mood symptoms and has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Item 8 assesses the participant's inability to feel. Scores range from 0 (normal interest in surroundings and other people) to 6 (emotional paralysis, inability to feel anger/grief/pleasure). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.
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Timepoint [5]
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Baseline, 8 weeks
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Secondary outcome [6]
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Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total and Item Scores at Week 8
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Assessment method [6]
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The MGH-CPFQ is a 7-item participant-rated questionnaire evaluating the participant's cognitive and physical well-being during the past month. The MGH-CPFQ assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 ("greater than normal") to 2 ("normal") to 6 ("totally absent"). Total scores range from 7 to 42. Higher scores indicate greater disease severity. The LS Mean Value was calculated from an analysis of covariance (ANCOVA) model with terms of treatment, pooled investigator, and baseline.
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Timepoint [6]
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Baseline, 8 weeks
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Secondary outcome [7]
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Change From Baseline in the Sheehan Disability Scale (SDS) Total and Individual Scores at Week 8
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Assessment method [7]
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The SDS is a participant-rated assessment. Total scores range from 0-30 with higher values indicating greater disruption in the participant's work/social/family life. Items 1-3 assess the effect of the participant's symptoms on work/school schedule, social life/leisure activities, and family life/home responsibilities, respectively. Item scores are 0-10; higher values indicate greater disruption. Number of unproductive days and days lost in past week (symptom related) were reported. LS Mean Value was calculated from an ANCOVA model with terms of treatment, pooled investigator, and baseline.
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Timepoint [7]
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Baseline, 8 weeks
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Secondary outcome [8]
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Percentage of Participants Who Relapsed During 8 Weeks
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Assessment method [8]
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Relapse is defined as achieving a Montgomery-Asberg Depression Rating Scale (MADRS) total score=16 at any time after baseline. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
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Timepoint [8]
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Baseline through 8 weeks
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Secondary outcome [9]
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Number of Days From Baseline to Relapse as Defined by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score =16 During 8 Weeks
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Assessment method [9]
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The number of days from baseline to the first relapse is defined as reaching a MADRS Total Score=16. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Censored participants were included in the Kaplan-Meier analysis, the minimum and maximum time to relapse have been calculated and reported here. Median time to relapse and quartiles could not be computationally calculated using the Kaplan-Meier procedure due to low event rate and high completion rate (censored).
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Timepoint [9]
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Baseline through 8 weeks
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Secondary outcome [10]
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Percentage of Participants Who Discontinue Due to Lack of Efficacy During 8 Weeks
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Assessment method [10]
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Percentage of participants who discontinue after baseline due to lack of efficacy in the investigator's opinion.
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Timepoint [10]
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Baseline through 8 weeks
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2010
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Sample size
Target
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Accrual to date
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Final
483
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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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
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Recruitment hospital [2]
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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
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Recruitment hospital [3]
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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
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Recruitment hospital [4]
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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
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Recruitment hospital [5]
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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
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Recruitment hospital [6]
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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
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Recruitment postcode(s) [1]
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4053 - Everton Park
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Recruitment postcode(s) [2]
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4000 - Spring Hill
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Recruitment postcode(s) [3]
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5065 - Glenside
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Recruitment postcode(s) [4]
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3175 - Dandenong
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Recruitment postcode(s) [5]
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VIC 3199 - Frankston
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Recruitment postcode(s) [6]
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3181 - Prahran
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Manitoba
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Country [2]
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Mexico
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State/province [2]
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Durango
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Country [3]
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Mexico
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State/province [3]
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Frac. Hacienda De Las Cruces
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Country [4]
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Mexico
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State/province [4]
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Mexico City
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Country [5]
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Russian Federation
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State/province [5]
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Moscow
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Country [6]
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Russian Federation
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State/province [6]
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Saint Petersburg
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Country [7]
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Taiwan
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State/province [7]
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Douliou City
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Country [8]
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Taiwan
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State/province [8]
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Kao Hsiung
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Country [9]
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Taiwan
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State/province [9]
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Tao-Yuan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Boehringer Ingelheim
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Address [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00985504
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00985504
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