A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression

January 13, 2011 updated by: Repligen Corporation

A Phase II Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Safety, Tolerability and Efficacy of RG2417 (Uridine) in the Treatment of Bipolar I Depression

The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms of bipolar I depression and to make sure it is safe in humans.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35226
        • Birmingham Psychiatry Pharmaceutical Studies, Inc.
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
        • K&S Professional Research Services
    • California
      • San Diego, California, United States, 92108
        • Affiliated Research Institute
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University
    • Florida
      • North Miami, Florida, United States, 33161
        • Behavioral Clinical Research
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solution, Inc.
      • Tampa, Florida, United States, 33613
        • University of South Florida College of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Center for Medical Research
      • Smyrna, Georgia, United States, 30080
        • Carman Research
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • Valle Vista Health System
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Louisiana State University Health Sciences Center
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Department of Pscyhiatry & Psychology
    • New York
      • Staten Island, New York, United States, 10305
        • Behavioral Medical Research of States Island
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Unvieristy of North Carolina - Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Raleigh, North Carolina, United States, 27609
        • Richard H. Weisler, MD, PA and Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Dayton, Ohio, United States, 45408
        • Midwest Clinical Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research Company
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Center for Clinical Investigations, Inc.
    • Pennsylvania
      • Pittsburg, Pennsylvania, United States, 15213
        • Western Psychiatric Institute Clinic
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02856
        • Lincoln Research
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Ralph H. Johnson VA Medical Center
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • CNS Healthcare
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University School of Medicine
    • Texas
      • Austin, Texas, United States, 78756
        • FutureSearch Trials of Austin
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas
      • Houston, Texas, United States, 77030
        • University of Texas, Houston Medical Center
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia
    • Washington
      • Bellevue, Washington, United States, 98004
        • Northwest Clinical Research Center
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
        • Dean Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bipolar I Disorder, most recent episode depressed
  • History of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms

Exclusion Criteria:

  • Current manic, hypomanic or mixed episode
  • Rapid cycling bipolar disorder (4 or more mood episodes in the last year)
  • Dementia or any other Axis I diagnosis (besides bipolar I) that requires treatment
  • Alcohol or drug dependence within 6 months; alcohol or drug abuse within 3 months
  • Positive urine drug test for amphetamines, cocaine metabolites, opiates and/or phencyclidine(PCP)
  • Axis II diagnosis likely to interfere with study compliance
  • Serious suicidal or homicidal risk
  • Sensitivity to any of the drug ingredients, including lactose
  • Women who are pregnant, breast feeding or refuse to use adequate birth control
  • Current seizure disorder
  • Current episode of depression is longer than 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RG2417
Oral RG2417 taken twice daily for 8 weeks
Drug: RG2417
1g bid dose escalates to 2g bid for weeks 2-8.
Other Names:
  • Uridine
Placebo Comparator: Placebo
Oral placebo taken twice daily for 8 weeks
Drug: Placebo
Similarly sized placebo pills to be taken in the same fashion as the RG2417 tablets.
Other Names:
  • Sugar Pill

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
MADRS Score
Time Frame: Baseline and weekly for 8 weeks
Baseline and weekly for 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
CGI-BP-S
Time Frame: Baseline and weekly for 8 weeks
Baseline and weekly for 8 weeks
Safety Findings (includes AE frequency, YMRS Score and CSSR-S Score)
Time Frame: Baseline, 8 weeks of study drug dosing and one follow up visit at 4 weeks
Baseline, 8 weeks of study drug dosing and one follow up visit at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Repligen Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gary Sachs, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RG2417-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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