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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905424
• Other study ID #: SPD489-203
• Status: Completed
• Phase: Phase 2
• Start date: July 30, 2009
• Est. completion date: August 4, 2010

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: August 4, 2010
• Est. primary completion date: August 4, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• History of non-response to multiple antidepressants

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Antidepressant + SPD489 (lisdexamfetamine dimesylate)
Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks
• Antidepressant + placebo
Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks

Locations

Country	Name	City	State
United States	Atlanta Institute of Medicine & Research	Atlanta	Georgia
United States	FutureSearch Clinical Trials, LP	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	Duke University Medical Center	Durham	North Carolina
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	North Star Medical Research, LLC	Middleburg Heights	Ohio
United States	Pharmacology Research Institute (PRI)	Newport Beach	California
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Vince & Associates Clinical Research	Overland Park	Kansas
United States	Summit Research Network	Portland	Oregon
United States	Affiliated Research Institute	San Diego	California
United States	Summit Research Network (Seattle), LLC	Seattle	Washington
United States	Carman Research	Smyrna	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & Publications (1)

Trivedi MH, Cutler AJ, Richards C, Lasser R, Geibel BB, Gao J, Sambunaris A, Patkar AA. A randomized controlled trial of the efficacy and safety of lisdexamfetamine dimesylate as augmentation therapy in adults with residual symptoms of major depressive di — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Augmentation Baseline for Non-Remitters in Montgomery-?sberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF)	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.	Augmentation Baseline, 6 weeks
Secondary	Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF	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.	Augmentation Baseline, 6 weeks
Secondary	Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6	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.	Augmentation Baseline, 6 weeks
Secondary	Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF	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.	6 weeks
Secondary	Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at 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)	Augmentation baseline
Secondary	Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6	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)	6 weeks
Secondary	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	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.	Augmentation Baseline and 6 weeks
Secondary	Change From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6	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.	Augmentation Baseline and 6 weeks
Secondary	Change From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6	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.	Augmentation Baseline and 6 weeks
Secondary	Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF	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.	Augmentation Baseline and 6 weeks
Secondary	Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF	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.	Augmentation Baseline and 6 weeks
Secondary	Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6	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.	Augmentation Baseline and 6 weeks
Secondary	Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF	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.	6 weeks
Secondary	Assessment in Remitters of CGI-S at 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)	Augmentation Baseline
Secondary	Assessment in Remitters of CGI-S at Week 6	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)	6 weeks
Secondary	Change From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6	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.	Augmentation baseline and 6 weeks
Secondary	Change From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6	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.	Augmentation baseline and 6 weeks
Secondary	Change From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6	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.	Augmentation baseline and 6 weeks

External Links

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