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NCT00922272 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
NCT00922272: Completed Phase 2 study, sponsored by Shire.
NCT00922272 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 92 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00922272, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
Study Summary
To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS).
Primary Outcome
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.
Interventions
- DRUG SPD489 (lisdexamfetamine dimesylate)
- DRUG Placebo matching SPD489 (lisdexamfetamine dimesylate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2009-09-14 |
| Est. Completion | 2011-01-20 |
| Phase | Phase 2 |
What the finished NCT00922272 record still lists
NCT00922272 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 2 interventions - of which SPD489 (lisdexamfetamine dimesylate) is the first listed.
NCT00922272 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00922272 about?
NCT00922272 is a clinical study titled "Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms". To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS).
What is the current status of trial NCT00922272?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2009-09-14. Estimated completion is 2011-01-20.
What interventions are being tested in trial NCT00922272?
The interventions under investigation include: SPD489 (lisdexamfetamine dimesylate) (DRUG), Placebo matching SPD489 (lisdexamfetamine dimesylate) (DRUG).
Who is sponsoring clinical trial NCT00922272?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00922272's enrollment target sits among peer trials
92 767th of 2000 higher than 1,230 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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