Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00905424
First received: May 18, 2009
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the treatment of major depressive disorder (MDD) as measured by mean change in total Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.


Condition Intervention Phase
Major Depressive Disorder
Drug: Antidepressant + SPD489 (lisdexamfetamine dimesylate)
Drug: Antidepressant + placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Exploratory Efficacy and Safety Study of SPD489 in Adults 18-55 Years With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF) [ Time Frame: Augmentation Baseline, 6 weeks ] [ Designated as safety issue: No ]
    MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.


Secondary Outcome Measures:
  • Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF [ Time Frame: Augmentation Baseline, 6 weeks ] [ Designated as safety issue: No ]
    The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.

  • Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6 [ Time Frame: Augmentation Baseline, 6 weeks ] [ Designated as safety issue: No ]
    Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.

  • Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

  • Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline [ Time Frame: Augmentation baseline ] [ Designated as safety issue: No ]
    CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

  • Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

  • Change From Augmentation Baseline for Non-Remitters in the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Scale Total Score at Week 6 [ Time Frame: Augmentation Baseline and 6 weeks ] [ Designated as safety issue: No ]
    BRIEF-A is a validated 75-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to develop interpretive reports. Lower scores reflect better functioning.

  • Change From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6 [ Time Frame: Augmentation Baseline and 6 weeks ] [ Designated as safety issue: No ]
    MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.

  • Change From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6 [ Time Frame: Augmentation Baseline and 6 weeks ] [ Designated as safety issue: No ]
    QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.

  • Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF [ Time Frame: Augmentation Baseline and 6 weeks ] [ Designated as safety issue: No ]
    MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.

  • Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF [ Time Frame: Augmentation Baseline and 6 weeks ] [ Designated as safety issue: No ]
    The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.

  • Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6 [ Time Frame: Augmentation Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.

  • Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

  • Assessment in Remitters of CGI-S at Augmentation Baseline [ Time Frame: Augmentation Baseline ] [ Designated as safety issue: No ]
    CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

  • Assessment in Remitters of CGI-S at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

  • Change From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6 [ Time Frame: Augmentation baseline and 6 weeks ] [ Designated as safety issue: No ]
    BRIEF-A is a validated 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.

  • Change From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6 [ Time Frame: Augmentation baseline and 6 weeks ] [ Designated as safety issue: No ]
    MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.

  • Change From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6 [ Time Frame: Augmentation baseline and 6 weeks ] [ Designated as safety issue: No ]
    QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.


Enrollment: 246
Study Start Date: July 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Antidepressant + SPD489
Drug: Antidepressant + SPD489 (lisdexamfetamine dimesylate)
Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks
Other Name: LDX, Vyvanse
Placebo Comparator: Placebo
Antidepressant + placebo
Drug: Antidepressant + placebo
Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults aged 18-55 with a primary diagnosis of nonpsychotic MDD

Exclusion Criteria:

  • History of non-response to multiple antidepressants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905424

Locations
United States, California
Pharmacology Research Institute (PRI)
Newport Beach, California, United States, 92660
Affiliated Research Institute
San Diego, California, United States, 92108
United States, Florida
Florida Clinical Research Center, LLC
Bradenton, Florida, United States, 34208
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States, 33912
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32809
United States, Georgia
Atlanta Institute of Medicine & Research
Atlanta, Georgia, United States, 30328
Carman Research
Smyrna, Georgia, United States, 30080
United States, Kansas
Vince & Associates Clinical Research
Overland Park, Kansas, United States, 66212
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Ohio
North Star Medical Research, LLC
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Summit Research Network
Portland, Oregon, United States, 97210
United States, Texas
FutureSearch Clinical Trials, LP
Austin, Texas, United States, 78756
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Summit Research Network (Seattle), LLC
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Madhukar H Trivedi, MD University of Texas
  More Information

Additional Information:
Publications:
Trivedi MH, Cutler AJ, Richards C, et al. A Randomized Controlled Trial of the Efficacy and Safety of Lisdexamfetamine Dimesylate as Augmentation Therapy in Adults With Residual Symptoms of Major Depressive Disorder After Treatment With Escitalopram. J Clin Psychiatry,2013;74(8):802-809

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00905424     History of Changes
Other Study ID Numbers: SPD489-203
Study First Received: May 18, 2009
Results First Received: June 15, 2011
Last Updated: August 26, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Dextroamphetamine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants

ClinicalTrials.gov processed this record on July 22, 2014