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NCT01500200 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)

A Phase 2 study of Major Depressive Disorder, sponsored by Alkermes.

Completed
Registry status
Phase 2
Development phase
142
Enrollment target
20
Study locations

NCT01500200 is a Phase 2 study of Major Depressive Disorder that has completed, run by Alkermes. The registered enrollment target is 142 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT01500200, a Phase 2 study of Major Depressive Disorder, has completed, sponsored by Alkermes.

COMPLETED
Registry status
Phase 2
Development phase
142 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.

Conditions Studied

Major Depressive Disorder

Interventions

  • DRUG Placebo
  • DRUG ALKS 5461

Study Locations (20)

Florida

  • Alkermes Investigational Site - Fort Myers
  • Alkermes Investigational Site - Lauderhill
  • Alkermes Investigational Site - Leesburg
  • Alkermes Investigational Site - North Miami
  • Alkermes Investigational Site - St. Petersburg

California

  • Alkermes Investigational Site - Oceanside
  • Alkermes Investigational Site - Santa Ana
  • Alkermes Investigational Site - Torrance

Massachusetts

  • Alkermes Investigational Site - Boston
  • Alkermes Investigational Site - Haverhill

New York

  • Alkermes Investigational Site - Brooklyn
  • Alkermes Investigational Site - New York

Ohio

  • Alkermes Investigational Site - Canton
  • Alkermes Investigational Site - Dayton

Arizona

  • Alkermes Investigational Site - Tucson

Georgia

  • Alkermes Investigational Site - Atlanta

Illinois

  • Alkermes Investigational Site - Hoffman Estates

Trial Details

FieldValue
Enrollment Target 142 participants
Start Date 2011-12
Est. Completion 2013-03
Phase Phase 2

Sponsor

Alkermes

66 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01500200

The ClinicalTrials.gov registry entry for NCT01500200 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (62% lower). The listed sponsor is Alkermes, which has 66 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01500200 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01500200 about?

NCT01500200 is a clinical study titled "A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)". This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.

What is the current status of trial NCT01500200?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2011-12. Estimated completion is 2013-03.

What conditions does trial NCT01500200 study?

This clinical trial studies the following conditions: Major Depressive Disorder.

What interventions are being tested in trial NCT01500200?

The interventions under investigation include: Placebo (DRUG), ALKS 5461 (DRUG).

Who is sponsoring clinical trial NCT01500200?

This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01500200 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.