Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant
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
1 other identifier
interventional
246
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 major-depressive-disorder
Started Jul 2009
Shorter than P25 for phase_2 major-depressive-disorder
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2009
CompletedFirst Posted
Study publicly available on registry
May 20, 2009
CompletedStudy Start
First participant enrolled
July 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2010
CompletedResults Posted
Study results publicly available
July 14, 2011
CompletedJune 14, 2021
June 1, 2021
1 year
May 18, 2009
June 15, 2011
June 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg 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 Outcomes (17)
Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF
Augmentation Baseline, 6 weeks
Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6
Augmentation Baseline, 6 weeks
Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF
6 weeks
Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline
Augmentation baseline
Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6
6 weeks
- +12 more secondary outcomes
Study Arms (2)
Active
EXPERIMENTALAntidepressant + SPD489
Placebo
PLACEBO COMPARATORAntidepressant + placebo
Interventions
Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks
Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks
Eligibility Criteria
You may qualify if:
- Adults aged 18-55 with a primary diagnosis of nonpsychotic MDD
You may not qualify if:
- History of non-response to multiple antidepressants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (15)
Pharmacology Research Institute (PRI)
Newport Beach, California, 92660, United States
Affiliated Research Institute
San Diego, California, 92108, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, 34208, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32809, United States
Atlanta Institute of Medicine & Research
Atlanta, Georgia, 30328, United States
Carman Research
Smyrna, Georgia, 30080, United States
Vince & Associates Clinical Research
Overland Park, Kansas, 66212, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Summit Research Network
Portland, Oregon, 97210, United States
FutureSearch Clinical Trials, LP
Austin, Texas, 78756, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Summit Research Network (Seattle), LLC
Seattle, Washington, 98104, United States
Related 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 disorder after treatment with escitalopram. J Clin Psychiatry. 2013 Aug;74(8):802-9. doi: 10.4088/JCP.13m08360.
PMID: 24021497RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2009
First Posted
May 20, 2009
Study Start
July 30, 2009
Primary Completion
August 4, 2010
Study Completion
August 4, 2010
Last Updated
June 14, 2021
Results First Posted
July 14, 2011
Record last verified: 2021-06