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COMPLETED Phase 3

Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose

NCT01421134 · View on ClinicalTrials.gov ↗

Study Summary

Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features.

Interventions

  • DRUG Placebo
  • DRUG Lurasidone

Study Locations (20)

California

  • Synergy Clinical Research Center — Escondido
  • Collaborative Neuroscience Network Inc. — Garden Grove
  • Stanford -VA Palo Alto Health Care System — Palo Alto
  • Clinical Innovations Inc. — Riverside
  • Artemis Institute for Clinical Research — San Diego

New York

  • Social Psychiatric Research Inst. (SPRI) Clinical Trials — Brooklyn
  • Village Clinical Research Inc. — New York
  • Finger Lakes Clinical Research — Rochester
  • Behavioral Medical Research of Staten Island — Staten Island

Texas

  • FutureSearch Trials of Dallas, LP — Dallas
  • Dept. of Psychiatry, UT Southwestern Medical Center — Dallas
  • Grayline Clinical Drug Trials — Wichita Falls

Alabama

  • Birmingham Psychiatry Pharmaceutical Studies, Inc. — Birmingham

Florida

  • Florida Clinical Research Center, LLC — Sarasota

Massachusetts

  • Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders — Boston

Missouri

  • St. Charles Psychiatric Associates/Midwest Research Group — Saint Charles

North Carolina

  • Psychiatry and Behavioral Sciences, Duke — Durham

Trial Details

FieldValue
Enrollment Target 211 participants
Start Date 2011-09
Est. Completion 2014-10
Phase Phase 3

Sponsor

Sumitomo Pharma America

65 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01421134

The ClinicalTrials.gov registry entry for NCT01421134 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 211 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 65 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Major Depressive Disorder With Mixed Features appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01421134 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01421134 about?

NCT01421134 is a clinical study titled "Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose". Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features.

What is the current status of trial NCT01421134?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 211 participants. The study started on 2011-09. Estimated completion is 2014-10.

What conditions does trial NCT01421134 study?

This clinical trial studies the following conditions: Major Depressive Disorder With Mixed Features. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01421134?

The interventions under investigation include: Placebo (DRUG), Lurasidone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01421134?

This trial is sponsored by Sumitomo Pharma America, which has 65 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01421134 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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