Trial · NCT01436149
Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
NCT01436149, Phase 3, Completed, Shire; results first posted 2014-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder. Trials, record NCT01436149. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01436149
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
- NCT number
- NCT01436149
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,262 participants, actual
- Lead sponsor
- Shire
- Conditions
- Major Depressive Disorder
- Interventions
- SPD489 (Lisdexamfetamine dimesylate ), Placebo
- First posted
- 2011-09-19
- Last updated
- 2021-06-09
- Other registries' IDs
- eudract:2011-003018-17
- Results first posted
- 2014-11-19
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks | 8 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 Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks | 8 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 Participants Achieving a 25% Response on the MADRS | up to 8 weeks | The percentage of subjects who achieved a 25% response (i.e., ≥25% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/Early Termination (ET) (Week 16/ET). |
| Secondary | Percentage of Participants Achieving a 50% Response on the MADRS | up to 8 weeks | The percentage of subjects who achieved a 50% response (i.e., ≥50% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/ET (Week 16/ET). |
| Secondary | Percentage of Participants Achieving Remission on the MADRS | up to 8 weeks | MADRS remission was defined as a MADRS total score of ≤10. A comparison was performed at Visit 14/ET (Week 16/ET). |
| Secondary | Mean Change From Baseline Over Time in MADRS Total Score | Baseline and up to 8 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 | Mean Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR) | up to 8 weeks | The QIDS-SR is a self-administered questionnaire designed to rate depressive symptoms. The scale contains 16 items, each scored using a 4-point scale ranging from 0 (representing the most favorable response \[low amount of symptom\]) to 3 (representing the least favorable response \[frequent/intense symptom\]). The total score could range from 0 (no depression) to 27 (very severe depression). Higher scores represent more severe depressive symptoms. |
| Secondary | Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2) | up to 8 weeks | Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life. |
| Secondary | Mean Change From Baseline in the Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF) | up to 8 weeks | The short form is a 16-item self-report questionnaire which evaluates general subject satisfaction with health, mood, relationships, functioning in daily life, and the treatment being taken. Overall level of satisfaction is evaluated on a 5-point scale from 1 (very poor) to 5 (very good). The total score ranges from 14-70 (last two items on the form are not included in the total score). A higher score indicates a better quality of life. |
| Secondary | Clinical Global Impressions - Global Improvement (CGI-I) | up to 8 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks | 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks | 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving a 25% Response on the MADRS | up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a 50% Response on the MADRS | up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Remission on the MADRS | up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline Over Time in MADRS Total Score | Baseline and up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR) | up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2) | up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF) | up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impressions - Global Improvement (CGI-I) | up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks | Antidepressant + Placebo | -6.3 | 95% Confidence Interval -7.6 to -4.9 | units on a scale | |
| Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks | Antidepressant + SPD489 | -6.1 | 95% Confidence Interval -7.5 to -4.8 | units on a scale | |
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks | Antidepressant + Placebo | -4.3 | 95% Confidence Interval -5.3 to -3.3 | units on a scale | |
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks | Antidepressant + SPD489 | -4.7 | 95% Confidence Interval -5.6 to -3.7 | units on a scale | |
| Percentage of Participants Achieving a 25% Response on the MADRS | Antidepressant + Placebo | 65.0 | percentage of participants | ||
| Percentage of Participants Achieving a 25% Response on the MADRS | Antidepressant + SPD489 | 74.5 | percentage of participants | ||
| Percentage of Participants Achieving a 50% Response on the MADRS | Antidepressant + Placebo | 38.5 | percentage of participants | ||
| Percentage of Participants Achieving a 50% Response on the MADRS | Antidepressant + SPD489 | 41.0 | percentage of participants | ||
| Percentage of Participants Achieving Remission on the MADRS | Antidepressant + Placebo | 22.5 | percentage of participants | ||
| Percentage of Participants Achieving Remission on the MADRS | Antidepressant + SPD489 | 18.5 | percentage of participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Antidepressant Lead-in Phase | STARTED | Antidepressant + Single-blind Placebo | 1,262 | |
| Antidepressant Lead-in Phase | STARTED | Antidepressant + Double-blind Placebo | 0 | |
| Antidepressant Lead-in Phase | STARTED | Antidepressant + Double-blind SPD489 | 0 | |
| Antidepressant Lead-in Phase | COMPLETED | Antidepressant + Single-blind Placebo | 896 | |
| Antidepressant Lead-in Phase | COMPLETED | Antidepressant + Double-blind Placebo | 0 | |
| Antidepressant Lead-in Phase | COMPLETED | Antidepressant + Double-blind SPD489 | 0 | |
| Antidepressant Lead-in Phase | NOT COMPLETED | Antidepressant + Single-blind Placebo | 366 | |
| Antidepressant Lead-in Phase | NOT COMPLETED | Antidepressant + Double-blind Placebo | 0 | |
| Antidepressant Lead-in Phase | NOT COMPLETED | Antidepressant + Double-blind SPD489 | 0 | |
| Randomized Phase | STARTED | Antidepressant + Single-blind Placebo | 492 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events30
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 + Placebo | 6 | 201 | 6 |
| other | Dry mouth | Gastrointestinal disorders | Antidepressant + SPD489 | 19 | 201 | 19 |
| other | Nausea | Gastrointestinal disorders | Antidepressant + Placebo | 10 | 201 | 11 |
| other | Nausea | Gastrointestinal disorders | Antidepressant + SPD489 | 13 | 201 | 13 |
| other | Nasopharyngitis | Infections and infestations | Antidepressant + Placebo | 4 | 201 | 4 |
| other | Nasopharyngitis | Infections and infestations | Antidepressant + SPD489 | 11 | 201 | 12 |
| other | Decreased appetite | Metabolism and nutrition disorders | Antidepressant + Placebo | 8 | 201 | 8 |
| other | Decreased appetite | Metabolism and nutrition disorders | Antidepressant + SPD489 | 15 | 201 | 17 |
| other | Headache | Nervous system disorders | Antidepressant + Placebo | 21 | 201 | 28 |
| other | Headache | Nervous system disorders | Antidepressant + SPD489 | 13 | 201 | 14 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Antidepressant + Placebo | ||
| Total, all-cause mortality | Antidepressant + SPD489 | ||
| Total, other adverse events | Antidepressant + Placebo | 54 | 201 |
| Total, other adverse events | Antidepressant + SPD489 | 70 | 201 |
| Total, serious adverse events | Antidepressant + Placebo | 5 | 201 |
| Total, serious adverse events | Antidepressant + SPD489 | 3 | 201 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27474961 | 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 + Placebo vs Antidepressant + SPD489: 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.
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