Major Depressive DisorderPhase 2NCT00985725
SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder
A Phase 2 study testing SPD489 (Lisdexamfetamine dimesylate) in people with Major Depressive Disorder, run by Shire at 33 sites in United States.
Trial summary
To evaluate the efficacy of SPD489 for the treatment of executive function impairments (EFI) when used as an adjunct to stable, standard therapy in the setting of partial or full remission from recurrent Major Depressive Disorder (MDD) as measured by the Global Executive Composite (GEC) T-score of the Behavioral… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- SPD489 (Lisdexamfetamine dimesylate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 33 sitesUnited States
- Study dates
- 29 Oct 2009to 18 Apr 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-55 with a primary diagnosis of nonpsychotic uni-polar depression
Who cannot join
- Current co-morbid psychiatric disorder
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
Atlanta Institute of Medicine & Research
Atlanta, Georgia, 30328
Northwest Clinical Research Center
Bellevue, Washington, 98007
Paramount Clinical Research
Bridgeville, Pennsylvania, 15017
North Carolina Neuropsychiatry, PA
Chapel Hill, North Carolina, 27514
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, 45242
Connecticut Clincal Research
Cromwell, Connecticut, 06416
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231
Duke University Medical Center
Durham, North Carolina, 27705
AccelRx Research
Fall River, Massachusetts, 02721
Bayou City Resesarch, LTD
Houston, Texas, 77007
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090
Sun Valley Research Center
Imperial, California, 92251
University Hills Clinical Research
Irving, Texas, 75062
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216
Amit Vijapura, MD
Jacksonville, Florida, 32256
Joliet Center for Clinical Research
Joliet, Illinois, 60435
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566
Capstone Clinical Research
Libertyville, Illinois, 60048
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, 68510
Pharmacology Research Center
Los Alamitos, California, 90720
Suburban Research Associates
Media, Pennsylvania, 19063
Scientific Clinical Research, Inc.
North Miami, Florida, 33161
Excell Research
Oceanside, California, 92056
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806
Psychiatric Associates
Overland Park, Kansas, 66211
Richard H. Weisler, MD, PA & Associates
Raleigh, North Carolina, 27609
St. Charles Psychiatric Associates
Saint Charles, Missouri, 63301
Neuropsychiatric Resesarch Center of Orange County
Santa Ana, California, 92701
Carman Research
Smyrna, Georgia, 30080
PsychCare Consultants Research
St Louis, Missouri, 63128
Richmond Behavioral Associates
Staten Island, New York, 10312
Wharton Research Center
Wharton, Texas, 77488
About this study
Official title: Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults With Clinically Significant, Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder
To evaluate the efficacy of SPD489 for the treatment of executive function impairments (EFI) when used as an adjunct to stable, standard therapy in the setting of partial or full remission from recurrent Major Depressive Disorder (MDD) as measured by the Global Executive Composite (GEC) T-score of the Behavioral Rating Inventory of Executive Functioning - Adult Version (BRIEF-A).
- Conditions
- Major Depressive Disorder
- Being tested
- SPD489 (Lisdexamfetamine dimesylate), Matching placebo
- Keywords
- Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPD489 (Lisdexamfetamine dimesylate)Drug
Also called Vyvanse
Oral, 20, 30, 40, 50, 60, and 70mg capsules, once daily
Matching placeboDrug
oral, once daily
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | SPD489 Receives: Drug: SPD489 (Lisdexamfetamine dimesylate) |
| Placebo | Placebo comparator | Placebo Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF)
BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Measured: Baseline and week 9
Secondary outcomes (14)
Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (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.
Measured: Baseline and week 9
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF
BRIEF-A is a validated 75-item questionnaire. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Measured: Baseline and week 9
Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint
This measures the speed and accuracy of basic mental functions. Scores are normalized from raw scores and present an age matched score relative to other people in a normative sample. Scores are normalized with a mean of 100 and standard deviation of 15. Scores < 70 indicate likely deficit and impairment, and scores > 110 indicate high function and capacity. Higher scores are better.
Measured: Baseline and up to 9 weeks/Endpoint
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at 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)
Measured: Baseline
Percent of Participants With CGI-S at up to 9 Weeks/Endpoint
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)
Measured: Up to 9 weeks/Endpoint
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, 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.
Measured: Week 9
Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint
The EWPS quantifies work performance, productivity attitudes and behaviors assessing 25 items on a scale ranging from 0 (high performance) to 4 (lowest performance). Scores range from 0 to 100 with 100 representing lowest productivity.
Measured: Baseline and up to 9 weeks/Endpoint
Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF
This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning.
Measured: Baseline and week 9
Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF
This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning.
Measured: Baseline and week 9
Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9
The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. Each of the 12 items is scored using various scales with a total score ranging from 0 (lowest level of health) to 100 (highest level of health).
Measured: Baseline and week 9
Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint
The Q-LES-Q is a 93-item self-report questionnaire on quality of life and health. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good) with a total score ranging from 93 to 465. Higher scores indicate greater satisfaction.
Measured: Baseline and up to 9 weeks/Endpoint
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11
ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.
Measured: Baseline and week 11
Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF
The GAD-7 is a 7-item self-report questionnaire for assessing anxiety severity. Each item is scored using a scale that ranges from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 21. Lower scores indicate a reduction in anxiety.
Measured: Baseline and week 9
Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9
The STS is an 8-question clinician-rated assessment of suicidal ideation, suicidal behavior, and accidents. The items are scored on a 5-point Likert scale from 0 (not at all) to 4 (extremely) and summed to produce a total score ranging from 0 to 32. Lower scores indicate reduced suicidal tendencies.
Measured: Baseline and week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study start29 Oct 2009
- Primary completion18 Apr 2011
- Study completion18 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985725
- Sponsor's protocol ID
- SPD489-205
- Status last verified
- May 2021
- First submitted
- 25 Sep 2009
- Last updated
- 8 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Madhoo M, Keefe RS, Roth RM, Sambunaris A, Wu J, Trivedi MH, Anderson CS, Lasser R. Lisdexamfetamine dimesylate augmentation in adults with persistent executive dysfunction after partial or full remission of major depressive disorder. Neuropsychopharmacology. 2014 May;39(6):1388-98. doi: 10.1038/npp.2013.334. Epub 2013 Dec 6.
PubMed 24309905
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults With Clinically Significant, Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00985725
- Acronym / sponsor ID
- SPD489-205
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2009 (actual)
- Primary completion
- 18 Apr 2011 (actual)
- Study completion
- 18 Apr 2011 (actual)
- First posted
- 28 Sep 2009 (estimated)
- Results
- Posted 6 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of SPD489 for the treatment of executive function impairments (EFI) when used as an adjunct to stable, standard therapy in the setting of partial or full remission from recurrent Major Depressive Disorder (MDD) as measured by the Global Executive Composite (GEC) T-score of the Behavioral Rating Inventory of Executive Functioning - Adult Version (BRIEF-A).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: SPD489 (Lisdexamfetamine dimesylate)SPD489 |
| Placebo | Placebo comparator | Drug: Matching placeboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults aged 18-55 with a primary diagnosis of nonpsychotic uni-polar depression
Key exclusion criteria (1 listed)
- Current co-morbid psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPD489 (Lisdexamfetamine dimesylate)Also: VyvanseOral, 20, 30, 40, 50, 60, and 70mg capsules, once daily | Drug | Active |
| Matching placebooral, once daily | Drug | Placebo |
Primary outcome
Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF)
Time frame: Baseline and week 9
BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
14 secondary outcomes
Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)
Time frame: Baseline and week 9
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF
Time frame: Baseline and week 9
Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint
Time frame: Baseline and up to 9 weeks/Endpoint
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
Time frame: Baseline
Percent of Participants With CGI-S at up to 9 Weeks/Endpoint
Time frame: Up to 9 weeks/Endpoint
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF
Time frame: Week 9
Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint
Time frame: Baseline and up to 9 weeks/Endpoint
Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF
Time frame: Baseline and week 9
Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF
Time frame: Baseline and week 9
Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9
Time frame: Baseline and week 9
Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint
Time frame: Baseline and up to 9 weeks/Endpoint
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11
Time frame: Baseline and week 11
Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF
Time frame: Baseline and week 9
Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9
Time frame: Baseline and week 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24309905Madhoo M, Keefe RS, Roth RM, Sambunaris A, Wu J, Trivedi MH, Anderson CS, Lasser R. Lisdexamfetamine dimesylate augmentation in adults with persistent executive dysfunction after partial or full remission of major depressive disorder. Neuropsychopharmacology. 2014 May;39(6):1388-98. doi: 10.1038/npp.2013.334. Epub 2013 Dec 6.
Related trials for Major Depressive Disorder
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Major Depressive Episode (MDE), Major Depressive Disorder (MDD)
RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Depression, Major Depressive Disorder
Not yet recruiting
Acceptance and Committment Therapy Combined With Ketamine in Difficult-to-Treat Depression.
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPD489 (Lisdexamfetamine dimesylate) in people with Major Depressive Disorder, run by Shire at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF) (time frame: Baseline and week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00985725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.