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COMPLETED Phase 2

Phase II Study to Assess RG2417 in the Treatment of Bipolar I Depression

NCT00322764 · View on ClinicalTrials.gov ↗

Study Summary

The primary purpose of this study is to determine the safety and efficacy of oral RG2417 (Uridine) when administered to patients with Bipolar I depression twice daily for six weeks.

Conditions Studied

Interventions

  • DRUG Uridine

Study Locations (11)

Texas

  • Future Search Trials of Austin — Austin
  • Future Search Trials of Dallas — Dallas
  • University of Texas Health Science Center at San Antonio — San Antonio

Ohio

  • University of Cincinnati — Cincinnati
  • Cleveland Clinic Foundation — Cleveland

California

  • Stanford University — Stanford

Georgia

  • Carman Research — Smyrna

Indiana

  • Indiana University-Purdue University Indianapolis — Indianapolis

Maryland

  • Marc Hertzman, MD, PC — Rockville

Massachusetts

  • Massachusetts General Hospital — Boston

New York

  • Medical & Behavioral Health Research, PC — New York

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2006-03
Phase Phase 2

Sponsor

Repligen Corporation

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00322764

The ClinicalTrials.gov registry entry for NCT00322764 describes a study currently listed as completed. It is categorized as Phase 2, 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 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Repligen Corporation, which has 1 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 Bipolar Depression appearing as the primary indexed condition, and to 1 intervention — of which Uridine 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: NCT00322764 reports 11 study locations spanning 8 distinct geographic areas — top geographies include Texas, Ohio, California. 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 NCT00322764 about?

NCT00322764 is a clinical study titled "Phase II Study to Assess RG2417 in the Treatment of Bipolar I Depression". The primary purpose of this study is to determine the safety and efficacy of oral RG2417 (Uridine) when administered to patients with Bipolar I depression twice daily for six weeks.

What is the current status of trial NCT00322764?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2006-03.

What conditions does trial NCT00322764 study?

This clinical trial studies the following conditions: Bipolar Depression. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00322764?

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

Who is sponsoring clinical trial NCT00322764?

This trial is sponsored by Repligen Corporation, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00322764 being conducted?

This trial has 11 study locations across California, Georgia, Indiana, Maryland, Massachusetts. 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