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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00812058

Enrollment

180

Registered

2008-12-19

Start date

2008-11-30

Completion date

2010-12-31

Last updated

2011-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar I Depression

Keywords

Bipolar Depression, Bipolar Disease, Bipolar Disorder, Bipolar, Manic Depression, Manic Depressive Disorder

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.

Interventions

DRUGRG2417

1g bid dose escalates to 2g bid for weeks 2-8.

DRUGPlacebo

Similarly sized placebo pills to be taken in the same fashion as the RG2417 tablets.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
MADRS Score	Baseline and weekly for 8 weeks

Secondary

Measure	Time frame
CGI-BP-S	Baseline and weekly for 8 weeks
Safety Findings (includes AE frequency, YMRS Score and CSSR-S Score)	Baseline, 8 weeks of study drug dosing and one follow up visit at 4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026