Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: Antidepressant + SPD489 (lisdexamfetamine dimesylate)Drug: Antidepressant + placebo
- Registration Number
- NCT00905424
- Lead Sponsor
- Shire
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 246
- Adults aged 18-55 with a primary diagnosis of nonpsychotic MDD
- History of non-response to multiple antidepressants
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Antidepressant + SPD489 (lisdexamfetamine dimesylate) Antidepressant + SPD489 Placebo Antidepressant + placebo Antidepressant + placebo
- Primary Outcome Measures
Name Time Method Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF) Augmentation Baseline, 6 weeks 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
Name Time Method Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF Augmentation Baseline, 6 weeks 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 Augmentation Baseline, 6 weeks 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 6 weeks 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 Augmentation baseline 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 6 weeks 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 Augmentation Baseline and 6 weeks 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 Augmentation Baseline and 6 weeks 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 Augmentation Baseline and 6 weeks 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 Augmentation Baseline and 6 weeks 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 Augmentation Baseline and 6 weeks 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 Augmentation Baseline and 6 weeks 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 6 weeks 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 Augmentation Baseline 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 6 weeks 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 Augmentation baseline and 6 weeks 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 Augmentation baseline and 6 weeks 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 Augmentation baseline and 6 weeks 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.
Trial Locations
- Locations (15)
Florida Clinical Research Center, LLC
🇺🇸Bradenton, Florida, United States
Summit Research Network (Seattle), LLC
🇺🇸Seattle, Washington, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Pharmacology Research Institute (PRI)
🇺🇸Newport Beach, California, United States
North Star Medical Research, LLC
🇺🇸Middleburg Heights, Ohio, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Gulfcoast Clinical Research Center
🇺🇸Fort Myers, Florida, United States
Affiliated Research Institute
🇺🇸San Diego, California, United States
Summit Research Network
🇺🇸Portland, Oregon, United States
FutureSearch Clinical Trials, LP
🇺🇸Austin, Texas, United States
Carman Research
🇺🇸Smyrna, Georgia, United States
Vince & Associates Clinical Research
🇺🇸Overland Park, Kansas, United States
Atlanta Institute of Medicine & Research
🇺🇸Atlanta, Georgia, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States