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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 is a Phase 3 study that was terminated before completion, run by Shire. The registered enrollment target is 1,570 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01436175
The ClinicalTrials.gov registry entry for NCT01436175 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,570 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SPD489 (Lisdexamfetamine dimesylate) + Antidepressant is the first listed.
NCT01436175 reports 0 study locations.
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.
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