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

Sponsor:	Repligen Corporation
Information provided by:	Repligen Corporation
ClinicalTrials.gov Identifier:	NCT00812058

Purpose

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.

Condition	Intervention	Phase
Bipolar I Depression	Drug: RG2417 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Uridine

U.S. FDA Resources

Further study details as provided by Repligen Corporation:

Primary Outcome Measures:

MADRS Score [ Time Frame: Baseline and weekly for 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CGI-BP-S [ Time Frame: Baseline and weekly for 8 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	180
Study Start Date:	November 2008
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: RG2417 Oral RG2417 taken twice daily for 8 weeks	Drug: RG2417 1g bid dose escalates to 2g bid for weeks 2-8. Other Name: 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 Name: Sugar Pill

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812058

Show 36 Study Locations

Sponsors and Collaborators

Repligen Corporation

Investigators

Principal Investigator:

Gary Sachs, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Hedy Dion, Repligen Corporation
ClinicalTrials.gov Identifier:	NCT00812058 History of Changes
Other Study ID Numbers:	RG2417-03
Study First Received:	December 18, 2008
Last Updated:	January 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Repligen Corporation:

Bipolar Depression
Bipolar Disease
Bipolar Disorder

Bipolar
Manic Depression
Manic Depressive Disorder

Additional relevant MeSH terms:

Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012