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NCT01436175 · ClinicalTrials.gov registry record · Phase 3
SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study
A Phase 3 study, sponsored by Shire.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,570
- Enrollment target
NCT01436175: Clinical Trial Phase 3 study, sponsored by Shire.
NCT01436175 is a Phase 3 study that was terminated before completion, run by Shire. The registered enrollment target is 1,570 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (103% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01436175, a Phase 3 study, was terminated before completion, sponsored by Shire.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,570 participants
- Enrollment target
Study Summary
This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489.
Primary Outcome
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.
Interventions
- DRUG SPD489 (Lisdexamfetamine dimesylate) + Antidepressant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,570 participants |
| Start Date | 2012-02-27 |
| Est. Completion | 2014-03-27 |
| Phase | Phase 3 |
Why NCT01436175 stopped before completion
NCT01436175 is an interventional study that assigns participants to a tested intervention. Its 1,570 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (103% higher).
The record links to 0 conditions, and to 1 intervention - of which SPD489 (Lisdexamfetamine dimesylate) + Antidepressant is the first listed.
NCT01436175 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01436175 about?
NCT01436175 is a clinical study titled "SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study". This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489.
What is the current status of trial NCT01436175?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,570 participants. The study started on 2012-02-27. Estimated completion is 2014-03-27.
What interventions are being tested in trial NCT01436175?
The interventions under investigation include: SPD489 (Lisdexamfetamine dimesylate) + Antidepressant (DRUG).
Who is sponsoring clinical trial NCT01436175?
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 NCT01436175's enrollment target sits among peer trials
1,570 150th of 2000 higher than 1,851 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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