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NCT00985725 · ClinicalTrials.gov registry record · Phase 2
SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 143
- Enrollment target
NCT00985725: Completed Phase 2 study, sponsored by Shire.
NCT00985725 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 143 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00985725, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 143 participants
- Enrollment target
Study Summary
To evaluate the efficacy of SPD489 for the treatment of executive function impairments (EFI) when used as an adjunct to stable, standard therapy in the setting of partial or full remission from recurrent Major Depressive Disorder (MDD) as measured by the Global Executive Composite (GEC) T-score of the Behavioral Rating Inventory of Executive Functioning - Adult Version (BRIEF-A).
Primary Outcome
BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Interventions
- DRUG Matching placebo
- DRUG SPD489 (Lisdexamfetamine dimesylate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2009-10-29 |
| Est. Completion | 2011-04-18 |
| Phase | Phase 2 |
What the finished NCT00985725 record still lists
NCT00985725 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Matching placebo is the first listed.
NCT00985725 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00985725 about?
NCT00985725 is a clinical study titled "SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder". To evaluate the efficacy of SPD489 for the treatment of executive function impairments (EFI) when used as an adjunct to stable, standard therapy in the setting of partial or full remission from recurrent Major Depressive Disorder (MDD) as measured by the Global Executive Composite (GEC) T-score of t...
What is the current status of trial NCT00985725?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 143 participants. The study started on 2009-10-29. Estimated completion is 2011-04-18.
What interventions are being tested in trial NCT00985725?
The interventions under investigation include: Matching placebo (DRUG), SPD489 (Lisdexamfetamine dimesylate) (DRUG).
Who is sponsoring clinical trial NCT00985725?
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 NCT00985725's enrollment target sits among peer trials
143 507th of 2000 higher than 1,494 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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