Trial · NCT01435759
SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
NCT01435759, Phase 2, Completed, Shire; results first posted 2015-02-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder. Trials, record NCT01435759. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01435759
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
- NCT number
- NCT01435759
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,197 participants, actual
- Lead sponsor
- Shire
- Conditions
- Major Depressive Disorder
- Interventions
Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg, Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg, Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg, Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg, Antidepressant + Placebo
- First posted
- 2011-09-19
- Last updated
- 2021-06-09
- Other registries' IDs
- eudract:2011-003615-28
- Results first posted
- 2015-02-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set) | Augmentation Baseline (Week 8) to Week 16 | 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. CHange in MADRS total score in Augmentsion Baseline to Week 16. |
| Secondary | Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 | From Augmentation Baseline (Week 8) to Week 16 | |
| Secondary | Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 | From Augmentation Baseline (Week 8) to Week 16 | |
| Secondary | Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16 | From Augmentation Baseline (Week 8) to Week 16 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 | From Augmentation Baseline (Week 8) to Week 16 | Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product. | mmHg | MEAN |
| SECONDARY | Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 | From Augmentation Baseline (Week 8) to Week 16 | Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product. | mmHg | MEAN |
| SECONDARY | Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16 | From Augmentation Baseline (Week 8) to Week 16 | Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product. | bpm | MEAN |
| PRIMARY | Change in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set) | Augmentation Baseline (Week 8) to Week 16 | Dose Response Evaluable Set (DRES): All randomized subjects who had at least 1 valid primary efficacy measurement (MADRS total score) during the Dose Maintenance Period (Weeks 11-16) while on the target dose level of investigational product. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 | Antidepressant + Double-blind Placebo | -0.2 | Standard Deviation 9.55 | mmHg | |
| Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 | Antidepressant + Double-blind SPD489 10mg | 0.2 | Standard Deviation 8.58 | mmHg | |
| Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 | Antidepressant + Double-blind SPD489 30mg | 0.5 | Standard Deviation 9.17 | mmHg | |
| Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 | Antidepressant + Double-blind SPD489 50mg | 3.5 | Standard Deviation 7.82 | mmHg | |
| Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 | Antidepressant + Double-blind SPD489 70mg | 2.6 | Standard Deviation 10.55 | mmHg | |
| Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 | Antidepressant + Double-blind Placebo | -0.1 | Standard Deviation 6.69 | mmHg | |
| Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 | Antidepressant + Double-blind SPD489 10mg | -0.9 | Standard Deviation 6.64 | mmHg | |
| Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 | Antidepressant + Double-blind SPD489 30mg | -0.1 | Standard Deviation 7.39 | mmHg | |
| Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 | Antidepressant + Double-blind SPD489 50mg | 2.8 | Standard Deviation 6.58 | mmHg | |
| Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 | Antidepressant + Double-blind SPD489 70mg | 1.9 | Standard Deviation 7.45 | mmHg |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow36
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 | 1,197 | |
| Antidepressant Lead-in Phase | STARTED | Antidepressant + Double-blind Placebo | 0 | |
| Antidepressant Lead-in Phase | STARTED | Antidepressant + Double-blind SPD489 10mg | 0 | |
| Antidepressant Lead-in Phase | STARTED | Antidepressant + Double-blind SPD489 30mg | 0 | |
| Antidepressant Lead-in Phase | STARTED | Antidepressant + Double-blind SPD489 50mg | 0 | |
| Antidepressant Lead-in Phase | STARTED | Antidepressant + Double-blind SPD489 70mg | 0 | |
| Antidepressant Lead-in Phase | COMPLETED | Antidepressant + Single-blind Placebo | 855 | |
| Antidepressant Lead-in Phase | COMPLETED | Antidepressant + Double-blind Placebo | 0 | |
| Antidepressant Lead-in Phase | COMPLETED | Antidepressant + Double-blind SPD489 10mg | 0 | |
| Antidepressant Lead-in Phase | COMPLETED | Antidepressant + Double-blind SPD489 30mg | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events80
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 | Diarrhoea | Gastrointestinal disorders | Antidepressant + Double-blind Placebo | 4 | 78 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Antidepressant + Double-blind SPD489 10mg | 2 | 77 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Antidepressant + Double-blind SPD489 30mg | 3 | 76 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Antidepressant + Double-blind SPD489 50mg | 2 | 78 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Antidepressant + Double-blind SPD489 70mg | 5 | 80 | 5 |
| other | Dry mouth | Gastrointestinal disorders | Antidepressant + Double-blind Placebo | 1 | 78 | 1 |
| other | Dry mouth | Gastrointestinal disorders | Antidepressant + Double-blind SPD489 10mg | 2 | 77 | 2 |
| other | Dry mouth | Gastrointestinal disorders | Antidepressant + Double-blind SPD489 30mg | 2 | 76 | 2 |
| other | Dry mouth | Gastrointestinal disorders | Antidepressant + Double-blind SPD489 50mg | 10 | 78 | 10 |
| other | Dry mouth | Gastrointestinal disorders | Antidepressant + Double-blind SPD489 70mg | 10 | 80 | 10 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Antidepressant + Double-blind Placebo | ||
| Total, all-cause mortality | Antidepressant + Double-blind SPD489 10mg | ||
| Total, all-cause mortality | Antidepressant + Double-blind SPD489 30mg | ||
| Total, all-cause mortality | Antidepressant + Double-blind SPD489 50mg | ||
| Total, all-cause mortality | Antidepressant + Double-blind SPD489 70mg | ||
| Total, other adverse events | Antidepressant + Double-blind Placebo | 20 | 78 |
| Total, other adverse events | Antidepressant + Double-blind SPD489 10mg | 30 | 77 |
| Total, other adverse events | Antidepressant + Double-blind SPD489 30mg | 29 | 76 |
| Total, other adverse events | Antidepressant + Double-blind SPD489 50mg | 36 | 78 |
| Total, other adverse events | Antidepressant + Double-blind SPD489 70mg | 44 | 80 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28857719 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01435759
GET https://conductscience.org/api/trials/v1/NCT01435759/flow?page=2