Trial · NCT00922272
Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms
NCT00922272, Phase 2, Completed, Shire; results first posted 2012-02-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms. Trials, record NCT00922272. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00922272
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms
- NCT number
- NCT00922272
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 92 participants, actual
- Lead sponsor
- Shire
- Conditions
- Schizophrenia and Predominant Negative Symptoms
- Interventions
- SPD489 (lisdexamfetamine dimesylate), Placebo matching SPD489 (lisdexamfetamine dimesylate)
- First posted
- 2009-06-17
- Last updated
- 2021-06-09
- Results first posted
- 2012-02-20
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Open-label Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Week 10 Open-label Phase, Last Observation Carried Forward (LOCF) | Open-label Baseline and Week 10 Open-label Phase | The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. |
| Primary | Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF) | Double-blind Randomization Baseline and Week 4 Double-blind Phase | The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. |
| Secondary | Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase | Week 10 Open-label Phase | Response is defined as reduction in total SANS score of greater than or equal to 20%. The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. |
| Secondary | Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase | Week 4 Double-blind Phase | Response is defined as reduction in total SANS score of greater than or equal to 20%. The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. |
| Secondary | Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase | Open-label Baseline and Week 10 Open-label Phase | The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. |
| Secondary | Change From Double-blind Randomization Baseline in SANS Global Scores at Week 4 Double-blind Phase | Double-blind Randomization Baseline and Week 4 Double-blind Phase | The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. |
| Secondary | Change From Open-label Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at Week 10 Open-label Phase, LOCF | Open-label Baseline and Week 10 Open-label Phase | The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. |
| Secondary | Change From Double-blind Randomization Baseline in PANSS Scores at Week 4 Double-blind Phase, TOCF | Double-blind Randomization Baseline and Week 4 Double-blind Phase | The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. |
| Secondary | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Open-label Baseline | Open-label 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 | Percent of Participants With CGI-S at Week 10 Open-label Phase | Week 10 Open-label Phase | 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) |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Open-label Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Week 10 Open-label Phase, Last Observation Carried Forward (LOCF) | Open-label Baseline and Week 10 Open-label Phase | Open-label Phase Full Analysis Set (FAS) defined as all enrolled subjects who took at least 1 dose of the investigational product and had 1 primary efficacy assessment after baseline in the Open-label Phase. | Units on a scale | MEAN |
| SECONDARY | Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase | Week 10 Open-label Phase | FAS | Percent of participants | NUMBER |
| PRIMARY | Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF) | Double-blind Randomization Baseline and Week 4 Double-blind Phase | Randomized Evaluable Set (RES) defined as all randomized subjects who were responders (Response is defined as reduction in total SANS score of greater than or equal to 20%) at the Double-blind Randomization and had SANS-18 total scores at week 4 of the Double-blind Phase or the early termination visit. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase | Week 4 Double-blind Phase | RES | Percent of participants | NUMBER |
| SECONDARY | Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase | Open-label Baseline and Week 10 Open-label Phase | FAS | Units on a scale | MEAN |
| SECONDARY | Change From Double-blind Randomization Baseline in SANS Global Scores at Week 4 Double-blind Phase | Double-blind Randomization Baseline and Week 4 Double-blind Phase | RES | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Open-label Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at Week 10 Open-label Phase, LOCF | Open-label Baseline and Week 10 Open-label Phase | FAS | Units on a scale | MEAN |
| SECONDARY | Change From Double-blind Randomization Baseline in PANSS Scores at Week 4 Double-blind Phase, TOCF | Double-blind Randomization Baseline and Week 4 Double-blind Phase | Randomized FAS defined as all subjects who received randomized investigational product and had a SANS-18 total scores at week 4 or at the early termination visit. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Open-label Baseline | Open-label Baseline | FAS | Percent of participants | NUMBER |
| SECONDARY | Percent of Participants With CGI-S at Week 10 Open-label Phase | Week 10 Open-label Phase | FAS | Percent of participants | NUMBER |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group123
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Open-label Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Week 10 Open-label Phase, Last Observation Carried Forward (LOCF) | SPD489 (Open-label Phase) | -12.9 | Standard Deviation 10.04 | Units on a scale | |
| Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase | SPD489 (Open-label Phase) | 52.9 | Percent of participants | ||
| Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF) | SPD489 (Double-blind Phase) | 4.5 | Standard Error 2.14 | Units on a scale | |
| Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF) | Placebo (Double-blind Phase) | 2.2 | Standard Error 1.85 | Units on a scale | |
| Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase | SPD489 (Double-blind Phase) | 71.4 | Percent of participants | ||
| Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase | Placebo (Double-blind Phase) | 82.4 | Percent of participants | ||
| Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase | SPD489 (Open-label Phase) | Affective Flattening | -0.9 | Standard Deviation 0.80 | Units on a scale |
| Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase | SPD489 (Open-label Phase) | Alogia | -0.9 | Standard Deviation 0.65 | Units on a scale |
| Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase | SPD489 (Open-label Phase) | Avolition-Apathy | -0.5 | Standard Deviation 0.81 | Units on a scale |
| Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase | SPD489 (Open-label Phase) | Anhedonia-Asociality | -0.7 | Standard Deviation 0.77 | Units on a scale |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-label Phase | STARTED | SPD489 | 92 | |
| Open-label Phase | STARTED | Placebo | 0 | |
| Open-label Phase | COMPLETED | SPD489 | 69 | |
| Open-label Phase | COMPLETED | Placebo | 0 | |
| Open-label Phase | NOT COMPLETED | SPD489 | 23 | |
| Open-label Phase | NOT COMPLETED | Placebo | 0 | |
| Double-blind Phase | STARTED | SPD489 | 34 | |
| Double-blind Phase | STARTED | Placebo | 35 | |
| Double-blind Phase | COMPLETED | SPD489 | 27 | |
| Double-blind Phase | COMPLETED | Placebo | 29 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events138
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 | Diarrhea | Gastrointestinal disorders | SPD489 (Open-label Phase) | 5 | 92 | |
| other | Diarrhea | Gastrointestinal disorders | SPD489 (Double-blind Phase) | 0 | 34 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo (Double-blind Phase) | 0 | 35 | |
| other | Dry Mouth | Gastrointestinal disorders | SPD489 (Open-label Phase) | 6 | 92 | |
| other | Dry Mouth | Gastrointestinal disorders | SPD489 (Double-blind Phase) | 1 | 34 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo (Double-blind Phase) | 0 | 35 | |
| other | Decreased Appetite | Metabolism and nutrition disorders | SPD489 (Open-label Phase) | 10 | 92 | |
| other | Decreased Appetite | Metabolism and nutrition disorders | SPD489 (Double-blind Phase) | 0 | 34 | |
| other | Decreased Appetite | Metabolism and nutrition disorders | Placebo (Double-blind Phase) | 0 | 35 | |
| other | Dizziness | Nervous system disorders | SPD489 (Open-label Phase) | 8 | 92 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SPD489 (Open-label Phase) | ||
| Total, all-cause mortality | SPD489 (Double-blind Phase) | ||
| Total, all-cause mortality | Placebo (Double-blind Phase) | ||
| Total, other adverse events | SPD489 (Open-label Phase) | 56 | 92 |
| Total, other adverse events | SPD489 (Double-blind Phase) | 11 | 34 |
| Total, other adverse events | Placebo (Double-blind Phase) | 7 | 35 |
| Total, serious adverse events | SPD489 (Open-label Phase) | 3 | 92 |
| Total, serious adverse events | SPD489 (Double-blind Phase) | 1 | 34 |
| Total, serious adverse events | Placebo (Double-blind Phase) | 2 | 35 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23756608 | 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.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Verbal Learning | Secondary outcome |
Source ConductCognition
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
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The record and each of its lists are JSON, twenty rows a page. No key.
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