Trial · NCT00905424
Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant
NCT00905424, Phase 2, Completed, Shire; results first posted 2011-07-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant. Trials, record NCT00905424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00905424
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant
- NCT number
- NCT00905424
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 246 participants, actual
- Lead sponsor
- Shire
- Conditions
- Major Depressive Disorder
- Interventions
- Antidepressant + SPD489 (lisdexamfetamine dimesylate), Antidepressant + placebo
- First posted
- 2009-05-20
- Last updated
- 2021-06-14
- Results first posted
- 2011-07-14
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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) |
| Secondary | 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) |
| 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 | 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. |
| Secondary | 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. |
| 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 | 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. |
| Secondary | 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. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Primary Efficacy Analysis Set defined as all non-remitters (MADRS total score greater than 10 at augmentation baseline) who take at least 1 dose of randomized augmentation treatment and have at least 1 primary efficacy measurement after randomization. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF | Augmentation Baseline, 6 weeks | Primary Efficacy Analysis Set | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6 | Augmentation Baseline, 6 weeks | Primary Efficacy Analysis Set | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF | 6 weeks | Primary Efficacy Analysis Set | Percent of Participants | NUMBER |
| SECONDARY | Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline | Augmentation baseline | Primary Efficacy Analysis Set | Percent of participants | NUMBER |
| SECONDARY | Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6 | 6 weeks | Primary Efficacy Analysis Set | Percent of participants | NUMBER |
| 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 | Augmentation Baseline and 6 weeks | Primary Efficacy Analysis Set | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Primary Efficacy Analysis Set | Units on a scale | LEAST_SQUARES_MEAN |
| 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 | Augmentation Baseline and 6 weeks | Primary Efficacy Analysis Set | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF | Augmentation Baseline and 6 weeks | Full Analysis Set (FAS) defined as all subjects who take at least 1 dose of randomized augmentation treatment and have at least 1 primary efficacy measurement after randomization. | Units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group92
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF) | Antidepressant + SPD489 (Non-remitters) | -7.1 | Standard Error 0.93 | Units on a scale | |
| Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF) | Antidepressant + Placebo (Non-remitters) | -4.9 | Standard Error 0.94 | Units on a scale | |
| Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF | Antidepressant + SPD489 (Non-remitters) | -4.9 | Standard Error 0.64 | Units on a scale | |
| Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF | Antidepressant + Placebo (Non-remitters) | -4.0 | Standard Error 0.65 | Units on a scale | |
| Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6 | Antidepressant + SPD489 (Non-remitters) | -3.7 | Standard Error 0.73 | Units on a scale | |
| Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6 | Antidepressant + Placebo (Non-remitters) | -1.7 | Standard Error 0.74 | Units on a scale | |
| Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF | Antidepressant + SPD489 (Non-remitters) | 60.0 | Percent of Participants | ||
| Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF | Antidepressant + Placebo (Non-remitters) | 45.3 | Percent of Participants | ||
| Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline | Antidepressant + SPD489 (Non-remitters) | Normal, not at all ill | 1.5 | Percent of participants | |
| Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline | Antidepressant + Placebo (Non-remitters) | Normal, not at all ill | 1.6 | Percent of participants |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Antidepressant + SPD489 | 89 | |
| Overall Study | STARTED | Antidepressant + Placebo . | 88 | |
| Overall Study | COMPLETED | Antidepressant + SPD489 | 78 | |
| Overall Study | COMPLETED | Antidepressant + Placebo . | 79 | |
| Overall Study | NOT COMPLETED | Antidepressant + SPD489 | 11 | |
| Overall Study | NOT COMPLETED | Antidepressant + Placebo . | 9 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry mouth | Gastrointestinal disorders | Antidepressant + SPD489 | 10 | 88 | |
| other | Dry mouth | Gastrointestinal disorders | Antidepressant + Placebo . | 0 | 85 | |
| other | Headache | Nervous system disorders | Antidepressant + SPD489 | 10 | 88 | |
| other | Headache | Nervous system disorders | Antidepressant + Placebo . | 4 | 85 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Antidepressant + SPD489 | 6 | 88 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Antidepressant + Placebo . | 2 | 85 | |
| other | Nasopharyngitis | Infections and infestations | Antidepressant + SPD489 | 5 | 88 | |
| other | Nasopharyngitis | Infections and infestations | Antidepressant + Placebo . | 3 | 85 | |
| other | Insomnia | Psychiatric disorders | Antidepressant + SPD489 | 4 | 88 | |
| other | Insomnia | Psychiatric disorders | Antidepressant + Placebo . | 6 | 85 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Antidepressant + SPD489 | ||
| Total, all-cause mortality | Antidepressant + Placebo . | ||
| Total, other adverse events | Antidepressant + SPD489 | 35 | 88 |
| Total, other adverse events | Antidepressant + Placebo . | 15 | 85 |
| Total, serious adverse events | Antidepressant + SPD489 | 0 | 88 |
| Total, serious adverse events | Antidepressant + Placebo . | 1 | 85 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24021497 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Antidepressant + SPD489 vs Antidepressant + Placebo .: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00905424
GET https://conductscience.org/api/trials/v1/NCT00905424/results?page=2