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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.

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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

FieldValue
Enrollment Target 1,570 participants
Start Date 2012-02-27
Est. Completion 2014-03-27
Phase Phase 3

Sponsor

Shire

245 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.