Trial · NCT01436175
SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study
NCT01436175, Phase 3, Terminated, Shire; results first posted 2015-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study. Trials, record NCT01436175. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01436175
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study
- NCT number
- NCT01436175
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,570 participants, actual
- Lead sponsor
- Shire
- Conditions
- Major Depressive Disorder
- Interventions
- SPD489 (Lisdexamfetamine dimesylate) + Antidepressant
- First posted
- 2011-09-19
- Last updated
- 2021-06-14
- Other registries' IDs
- eudract:2011-003019-47
- Results first posted
- 2015-02-23
- Limitations and caveats
- The study was terminated on 11 Feb 2014. SPD489 failed to demonstrate a benefit as adjunctive treatment to antidepressants. Termination was not related to any new safety findings.
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 5 up to Week 52/Early Termination(ET) | C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviour during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. |
| Primary | Change From Baseline in Systolic Blood Pressure at Week 52 | Baseline, Week 52/ET | Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]). |
| Primary | Change From Baseline in Diastolic Blood Pressure at Week 52 | Baseline, Week 52/ET | Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]). |
| Primary | Change From Baseline in Pulse Rate at Week 52 | Baseline, Week 52/ET | Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]). |
| Secondary | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET | Baseline, Week 52/ET | Designed to evaluate the extent to which illness symptoms impact a participant's life in 3 areas: work, 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. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]). |
| Secondary | Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I) | Week 52/ET | Participants who did not have Clinical Global Impressions - Severity of Illness (CGI-S) assessed at Week 8 in the antecedent study should not have had CGI-I assessed in this study and were excluded from the summary of CGI-I. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale. |
| Secondary | Short Form-12 Health Survey Version 2 (SF-12V2) | Week 52/ET | SF-12V2 is a multi-purpose, 7-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It is expressed by two summary measures (Aggregate Physical and Aggregate Mental) for which values can range from 0 to 100. A higher score is indicative of a better health state. |
| Secondary | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility | Week 52/ET | Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses |
| Secondary | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care | Week 52/ET | Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses |
| Secondary | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities | Week 52/ET | Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 5 up to Week 52/Early Termination(ET) | Safety analysis set included all participants who took at least 1 dose of investigational product and had at least 1 post-Visit 0 (Week 0) safety assessment in this study | participants | NUMBER |
| PRIMARY | Change From Baseline in Systolic Blood Pressure at Week 52 | Baseline, Week 52/ET | Safety Analysis Set. Here n = participants evaluable at specified time-points. | millimeter of mercury(mmHg) | MEAN |
| PRIMARY | Change From Baseline in Diastolic Blood Pressure at Week 52 | Baseline, Week 52/ET | Safety Analysis Set. Here n = participants evaluable at specified time-points. | mmHg | MEAN |
| PRIMARY | Change From Baseline in Pulse Rate at Week 52 | Baseline, Week 52/ET | Safety Analysis Set. Here n = participants evaluable at specified time-points. | beats per minute(bpm) | MEAN |
| SECONDARY | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET | Baseline, Week 52/ET | Full Analysis Set (FAS) included all participants in the Safety Analysis Set who had at least 1 clinical experience outcome assessment in the study. Here n = participants evaluable at specified time-points. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I) | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | participants | NUMBER |
| SECONDARY | Short Form-12 Health Survey Version 2 (SF-12V2) | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | participants | NUMBER |
| SECONDARY | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | participants | NUMBER |
| SECONDARY | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities | Week 52/ET | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | participants | NUMBER |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group81
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Columbia-Suicide Severity Rating Scale (C-SSRS) | SPD489 + Antidepressant | Positive Suicidal Ideation | 68 | participants | |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | SPD489 + Antidepressant | Suicidal Attempt | 4 | participants | |
| Change From Baseline in Systolic Blood Pressure at Week 52 | SPD489 + Antidepressant | Baseline (n = 1559) | 117.6 | Standard Deviation 11.13 | millimeter of mercury(mmHg) |
| Change From Baseline in Systolic Blood Pressure at Week 52 | SPD489 + Antidepressant | Change at Week 52/ET (n = 1558) | 2.4 | Standard Deviation 10.37 | millimeter of mercury(mmHg) |
| Change From Baseline in Diastolic Blood Pressure at Week 52 | SPD489 + Antidepressant | Baseline (n = 1559) | 75.4 | Standard Deviation 8.15 | mmHg |
| Change From Baseline in Diastolic Blood Pressure at Week 52 | SPD489 + Antidepressant | Change at Week 52/ET (n = 1558) | 1.2 | Standard Deviation 7.94 | mmHg |
| Change From Baseline in Pulse Rate at Week 52 | SPD489 + Antidepressant | Baseline (n = 1559) | 72.7 | Standard Deviation 9.90 | beats per minute(bpm) |
| Change From Baseline in Pulse Rate at Week 52 | SPD489 + Antidepressant | Change at Week 52/ET (n = 1558) | 5.2 | Standard Deviation 10.58 | beats per minute(bpm) |
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET | SPD489 + Antidepressant | Baseline (n=1548) | 12.7 | Standard Deviation 7.06 | units on a scale |
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET | SPD489 + Antidepressant | Change at Week 52/ET (n = 1530) | -4.3 | Standard Deviation 7.77 | units on a scale |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SPD489 + Antidepressant | 1,570 | |
| Overall Study | COMPLETED | SPD489 + Antidepressant | 300 | |
| Overall Study | NOT COMPLETED | SPD489 + Antidepressant | 1,270 |
Source ClinicalTrials.gov
Adverse events52
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 | SPD489 + Antidepressant | 212 | 1,559 | 233 |
| other | Nausea | Gastrointestinal disorders | SPD489 + Antidepressant | 116 | 1,559 | 132 |
| other | Fatigue | General disorders | SPD489 + Antidepressant | 80 | 1,559 | 82 |
| other | Feeling jittery | General disorders | SPD489 + Antidepressant | 82 | 1,559 | 89 |
| other | Irritability | General disorders | SPD489 + Antidepressant | 79 | 1,559 | 87 |
| other | Nasopharyngitis | Infections and infestations | SPD489 + Antidepressant | 137 | 1,559 | 156 |
| other | Upper respiratory tract infection | Infections and infestations | SPD489 + Antidepressant | 100 | 1,559 | 117 |
| other | Decreased appetite | Metabolism and nutrition disorders | SPD489 + Antidepressant | 189 | 1,559 | 210 |
| other | Dizziness | Nervous system disorders | SPD489 + Antidepressant | 91 | 1,559 | 102 |
| other | Headache | Nervous system disorders | SPD489 + Antidepressant | 241 | 1,559 | 347 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SPD489 + Antidepressant | ||
| Total, other adverse events | SPD489 + Antidepressant | 921 | 1,559 |
| Total, serious adverse events | SPD489 + Antidepressant | 33 | 1,559 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01436175
GET https://conductscience.org/api/trials/v1/NCT01436175/registered?page=2