Major Depressive DisorderPhase 2NCT00905424
Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant
A Phase 2 study testing Antidepressant + SPD489 (lisdexamfetamine dimesylate) in people with Major Depressive Disorder, run by Shire at 15 sites in United States.
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. 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?
- Antidepressant + 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
- 246 participants
- Where
- 15 sitesUnited States
- Study dates
- 30 Jul 2009to 4 Aug 2010
- 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 MDD
Who cannot join
- History of non-response to multiple antidepressants
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Atlanta Institute of Medicine & Research
Atlanta, Georgia, 30328
FutureSearch Clinical Trials, LP
Austin, Texas, 78756
Northwest Clinical Research Center
Bellevue, Washington, 98007
Florida Clinical Research Center, LLC
Bradenton, Florida, 34208
Duke University Medical Center
Durham, North Carolina, 27705
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130
Pharmacology Research Institute (PRI)
Newport Beach, California, 92660
IPS Research Company
Oklahoma City, Oklahoma, 73103
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32809
Vince & Associates Clinical Research
Overland Park, Kansas, 66212
Summit Research Network
Portland, Oregon, 97210
Affiliated Research Institute
San Diego, California, 92108
Summit Research Network (Seattle), LLC
Seattle, Washington, 98104
Carman Research
Smyrna, Georgia, 30080
About this study
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
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Antidepressant + SPD489 (lisdexamfetamine dimesylate), Antidepressant + placebo
- 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.
Antidepressant + SPD489 (lisdexamfetamine dimesylate)Drug
Also called LDX, Vyvanse
Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks
Antidepressant + placeboDrug
Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Antidepressant + SPD489 Receives: Drug: Antidepressant + SPD489 (lisdexamfetamine dimesylate) |
| Placebo | Placebo comparator | Antidepressant + placebo Receives: Drug: Antidepressant + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Augmentation Baseline, 6 weeks
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.
Measured: Augmentation Baseline, 6 weeks
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.
Measured: 6 weeks
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)
Measured: Augmentation baseline
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)
Measured: 6 weeks
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.
Measured: Augmentation Baseline and 6 weeks
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.
Measured: Augmentation Baseline and 6 weeks
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.
Measured: Augmentation Baseline and 6 weeks
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.
Measured: Augmentation Baseline and 6 weeks
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.
Measured: Augmentation Baseline and 6 weeks
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.
Measured: Augmentation Baseline and 6 weeks
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.
Measured: 6 weeks
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)
Measured: Augmentation Baseline
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)
Measured: 6 weeks
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.
Measured: Augmentation baseline and 6 weeks
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.
Measured: Augmentation baseline and 6 weeks
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.
Measured: Augmentation baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study start30 Jul 2009
- Primary completion4 Aug 2010
- Study completion4 Aug 2010
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
- 246 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
- NCT00905424
- Sponsor's protocol ID
- SPD489-203
- Status last verified
- Jun 2021
- First submitted
- 18 May 2009
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24021497
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00905424
- Acronym / sponsor ID
- SPD489-203
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2009 (actual)
- Primary completion
- 4 Aug 2010 (actual)
- Study completion
- 4 Aug 2010 (actual)
- First posted
- 20 May 2009 (estimated)
- Results
- Posted 14 Jul 2011
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 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.
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: Antidepressant + SPD489 (lisdexamfetamine dimesylate)Antidepressant + SPD489 |
| Placebo | Placebo comparator | Drug: Antidepressant + placeboAntidepressant + placebo |
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 MDD
Key exclusion criteria (1 listed)
- History of non-response to multiple antidepressants
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 |
|---|---|---|
| Antidepressant + SPD489 (lisdexamfetamine dimesylate)Also: LDX, VyvanseEscitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks | Drug | Active |
| Antidepressant + placeboEscitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks | Drug | Placebo |
Primary outcome
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
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.
17 secondary outcomes
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
Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6
Time frame: Augmentation Baseline, 6 weeks
Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF
Time frame: 6 weeks
Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline
Time frame: Augmentation baseline
Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6
Time frame: 6 weeks
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
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
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
Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF
Time frame: Augmentation Baseline and 6 weeks
Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF
Time frame: Augmentation Baseline and 6 weeks
Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6
Time frame: Augmentation Baseline and 6 weeks
Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF
Time frame: 6 weeks
Assessment in Remitters of CGI-S at Augmentation Baseline
Time frame: Augmentation Baseline
Assessment in Remitters of CGI-S at Week 6
Time frame: 6 weeks
Change From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6
Time frame: Augmentation baseline and 6 weeks
Change From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6
Time frame: Augmentation baseline and 6 weeks
Change From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6
Time frame: Augmentation baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24021497Trivedi 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.
- FDA Recall InformationLink provided by the sponsor.
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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
15 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 Antidepressant + SPD489 (lisdexamfetamine dimesylate) in people with Major Depressive Disorder, run by Shire at 15 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 14 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 15 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 14 Jul 2011). 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 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). 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 NCT00905424, 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 14 Jun 2021.