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

November 8, 2007 updated by: Repligen Corporation

Dose-Escalating, Phase II Study to Assess the Safety and Tolerability of 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.

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.
80

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
    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • Georgia
      • Smyrna, Georgia, United States, 30080
        • Carman Research
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University-Purdue University Indianapolis
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Marc Hertzman, MD, PC
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • New York
      • New York City, New York, United States, 10023
        • Medical & Behavioral Health Research, PC
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Texas
      • Austin, Texas, United States, 78756
        • Future Search Trials of Austin
      • Dallas, Texas, United States, 75231
        • Future Search Trials of Dallas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio

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

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. DSM-IV-TR diagnosis of Bipolar I Depression
  2. 18 to 65 years of age, inclusive
  3. Depressive phase, as measured by MADRS greater than or equal to 20 at Screening and Day1
  4. Duration of current depressive episode of at least four weeks by Day 1
  5. Competent to give informed consent

Exclusion Criteria:

  1. Manic/hypomanic/mixed episode as determined by the MINI at Screening and/or a Young Mania Rating Scale (YMRS) score of > 12 at Screening and/or Day 1
  2. Dementia or any current Axis I diagnosis (excluding bipolar I) requiring pharmacological treatments
  3. A history of alcohol or substance dependence within six months of Day 1, or a history of alcohol or substance abuse within three months of Day 1
  4. Urine drug screen positive for amphetamines, cocaine metabolites, opiates and/or phencyclindine (PCP)
  5. An Axis II diagnosis that is likely to interfere with protocol compliance
  6. Initiation of or increase in psychotherapy within 4 weeks of Screening
  7. Psychotropic medication (excluding fluoxetine) within 24 hours of initiation of study drug on Day 1; fluoxetine within 2 weeks of initiation of study drug on Day 1
  8. Serious suicidal or homicidal risk as determined by the investigator and/or a score of > 5 on the suicide item #10 of the MADRS at Screening and/or Day 1
  9. History of sensitivity to any of the ingredients in the study drug
  10. Clinically significant abnormality in any screening laboratory results
  11. Clinically significant organic disease, including cardiovascular, endocrine, hepatic, pulmonary, neurologic, or renal disease, or any other medical condition, serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would interfere with the performance or interpretability of, or put the patient at risk from, the study procedures
  12. Women who are pregnant, breastfeeding, or refuse to use adequate birth control
  13. Current seizure disorder
  14. Participation in an investigational drug study within twenty-eight days of Day 1
  15. Current psychotic episode
  16. Clozaril use and/or electroconvulsive therapy within six months of Day 1
  17. Failure of three or more adequate trials of standard therapies for depression during the current episode
  18. Current episode of depression is longer than one 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
  • Masking: DOUBLE

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
Improvement of MADRS and CGI BP C for RG2417 treatment in comparison to placebo

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.
  • Study Director: David Jacoby, MD, PhD, Repligen Corporation

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.
March 1, 2006

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).
May 4, 2006

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.
May 4, 2006

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.
May 8, 2006

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.
November 9, 2007

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.
November 8, 2007

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.
November 1, 2007

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.
  • RG2417-01

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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