Clinical trial NCT00812058: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bipolar I Depression
Keywords: Bipolar Depression
Bipolar Disease
Bipolar Disorder
Bipolar
Manic Depression
Manic Depressive Disorder
Lead sponsor: Repligen Corporation
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: MADRS Score
timeFrame: Baseline and weekly for 8 weeks
Secondary outcomes:
measure: CGI-BP-S
timeFrame: Baseline and weekly for 8 weeks
measure: Safety Findings (includes AE frequency, YMRS Score and CSSR-S Score)
timeFrame: Baseline, 8 weeks of study drug dosing and one follow up visit at 4 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Psychiatry Pharmaceutical Studies, Inc.
state: Alabama
city: Little Rock
country: United States
facility: K&S Professional Research Services
state: Arkansas
city: San Diego
country: United States
facility: Affiliated Research Institute
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: North Miami
country: United States
facility: Behavioral Clinical Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solution, Inc.
state: Florida
city: Tampa
country: United States
facility: University of South Florida College of Medicine
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Greenwood
country: United States
facility: Valle Vista Health System
state: Indiana
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Department of Pscyhiatry & Psychology
state: Minnesota
city: Staten Island
country: United States
facility: Behavioral Medical Research of States Island
state: New York
city: Chapel Hill
country: United States
facility: Unvieristy of North Carolina - Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Richard H. Weisler, MD, PA and Associates
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Portland
country: United States
facility: Oregon Center for Clinical Investigations, Inc.
state: Oregon
city: Pittsburg
country: United States
facility: Western Psychiatric Institute Clinic
state: Pennsylvania
city: Lincoln
country: United States
facility: Lincoln Research
state: Rhode Island
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center
state: South Carolina
city: Memphis
country: United States
facility: CNS Healthcare
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University School of Medicine
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Austin
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: Houston
country: United States
facility: University of Texas, Houston Medical Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Middleton
country: United States
facility: Dean Foundation
state: Wisconsin
Study officials:
affiliation: Massachusetts General Hospital
name: Gary Sachs, MD
role: PRINCIPAL_INVESTIGATOR
References: