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

Primary Purpose

Bipolar I Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RG2417
Placebo
Sponsored by
Repligen Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar I Depression focused on measuring Bipolar Depression, Bipolar Disease, Bipolar Disorder, Bipolar, Manic Depression, Manic Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Birmingham Psychiatry Pharmaceutical Studies, Inc.
  • K&S Professional Research Services
  • Affiliated Research Institute
  • Yale University
  • Behavioral Clinical Research
  • Clinical Neuroscience Solution, Inc.
  • University of South Florida College of Medicine
  • Atlanta Center for Medical Research
  • Carman Research
  • Valle Vista Health System
  • Louisiana State University Health Sciences Center
  • Johns Hopkins School of Medicine
  • Massachusetts General Hospital
  • Mayo Clinic Department of Pscyhiatry & Psychology
  • Behavioral Medical Research of States Island
  • Unvieristy of North Carolina - Chapel Hill
  • Duke University Medical Center
  • Richard H. Weisler, MD, PA and Associates
  • University of Cincinnati
  • Cleveland Clinic
  • Midwest Clinical Research Center
  • IPS Research Company
  • Oregon Center for Clinical Investigations, Inc.
  • Western Psychiatric Institute Clinic
  • Lincoln Research
  • Ralph H. Johnson VA Medical Center
  • CNS Healthcare
  • Vanderbilt University School of Medicine
  • FutureSearch Trials of Austin
  • FutureSearch Trials of Dallas
  • University of Texas, Houston Medical Center
  • University of Texas Health Science Center at San Antonio
  • University of Utah
  • University of Virginia
  • Northwest Clinical Research Center
  • Dean Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RG2417

Placebo

Arm Description

Oral RG2417 taken twice daily for 8 weeks

Oral placebo taken twice daily for 8 weeks

Outcomes

Primary Outcome Measures

MADRS Score

Secondary Outcome Measures

CGI-BP-S
Safety Findings (includes AE frequency, YMRS Score and CSSR-S Score)

Full Information

First Posted
December 18, 2008
Last Updated
January 13, 2011
Sponsor
Repligen Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00812058
Brief Title
A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Repligen Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar I Depression
Keywords
Bipolar Depression, Bipolar Disease, Bipolar Disorder, Bipolar, Manic Depression, Manic Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RG2417
Arm Type
Experimental
Arm Description
Oral RG2417 taken twice daily for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo taken twice daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
RG2417
Other Intervention Name(s)
Uridine
Intervention Description
1g bid dose escalates to 2g bid for weeks 2-8.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
Similarly sized placebo pills to be taken in the same fashion as the RG2417 tablets.
Primary Outcome Measure Information:
Title
MADRS Score
Time Frame
Baseline and weekly for 8 weeks
Secondary Outcome Measure Information:
Title
CGI-BP-S
Time Frame
Baseline and weekly for 8 weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Sachs, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham Psychiatry Pharmaceutical Studies, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35226
Country
United States
Facility Name
K&S Professional Research Services
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
Facility Name
Affiliated Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Behavioral Clinical Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Clinical Neuroscience Solution, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of South Florida College of Medicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Carman Research
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Valle Vista Health System
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States
Facility Name
Louisiana State University Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mayo Clinic Department of Pscyhiatry & Psychology
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Behavioral Medical Research of States Island
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Unvieristy of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Richard H. Weisler, MD, PA and Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Oregon Center for Clinical Investigations, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Western Psychiatric Institute Clinic
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Lincoln Research
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02856
Country
United States
Facility Name
Ralph H. Johnson VA Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
CNS Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Vanderbilt University School of Medicine
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
FutureSearch Trials of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
FutureSearch Trials of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Texas, Houston Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Dean Foundation
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States

12. IPD Sharing Statement

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

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