Trial · NCT01738698
Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia
NCT01738698, Phase 3, Terminated, Shire; results first posted 2014-05-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia. Trials, record NCT01738698. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01738698
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia
- NCT number
- NCT01738698
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 4 participants, actual
- Lead sponsor
- Shire
- Conditions
- Schizophrenia
- Interventions
- SPD489 40mg, SPD489 100mg, SPD489 160mg, Placebo
- First posted
- 2012-11-30
- Last updated
- 2021-06-22
- Other registries' IDs
- eudract:2012-003918-14
- Results first posted
- 2014-05-29
- Limitations and caveats
- Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Negative Symptom Assessment - 16-item (NSA-16) Total Score at 12 Weeks | Baseline and 12 weeks | |
| Secondary | Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks | Baseline and 12 weeks | |
| Secondary | Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks | Baseline and 12 weeks | |
| Secondary | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks | Baseline and 12 weeks | |
| Secondary | Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks | Baseline and 12 weeks | |
| Secondary | Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks | Baseline and 12 weeks | |
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 12 Weeks | Baseline and 12 weeks | |
| Secondary | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 12 Weeks | Baseline and 12 weeks | |
| Secondary | Change From Baseline in Social Functioning Scale (SFS) at 12 Weeks | Baseline and 12 weeks | |
| Secondary | Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 12 Weeks | Baseline and 12 weeks |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Negative Symptom Assessment - 16-item (NSA-16) Total Score at 12 Weeks | Baseline and 12 weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | ||
| SECONDARY | Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks | Baseline and 12 weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | ||
| SECONDARY | Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks | Baseline and 12 weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | ||
| SECONDARY | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks | Baseline and 12 weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | ||
| SECONDARY | Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks | Baseline and 12 weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | ||
| SECONDARY | Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks | Baseline and 12 weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | ||
| SECONDARY | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 12 Weeks | Baseline and 12 weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | ||
| SECONDARY | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 12 Weeks | Baseline and 12 weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | ||
| SECONDARY | Change From Baseline in Social Functioning Scale (SFS) at 12 Weeks | Baseline and 12 weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | ||
| SECONDARY | Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 12 Weeks | Baseline and 12 weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SPD489 40mg | 0 | |
| Overall Study | STARTED | SPD489 100mg | 0 | |
| Overall Study | STARTED | SPD489 160mg | 0 | |
| Overall Study | STARTED | Placebo | 0 | |
| Overall Study | COMPLETED | SPD489 40mg | 0 | |
| Overall Study | COMPLETED | SPD489 100mg | 0 | |
| Overall Study | COMPLETED | SPD489 160mg | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | SPD489 40mg | 0 | |
| Overall Study | NOT COMPLETED | SPD489 100mg | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SPD489 40mg | ||
| Total, all-cause mortality | SPD489 100mg | ||
| Total, all-cause mortality | SPD489 160mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | SPD489 40mg | 0 | 0 |
| Total, other adverse events | SPD489 100mg | 0 | 0 |
| Total, other adverse events | SPD489 160mg | 0 | 0 |
| Total, other adverse events | Placebo | 0 | 0 |
| Total, serious adverse events | SPD489 40mg | 0 | 0 |
| Total, serious adverse events | SPD489 100mg | 0 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT01738698
GET https://conductscience.org/api/trials/v1/NCT01738698/registered