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OpenTrials
Completed

NCT Number: NCT00812058

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

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.

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Key information

Conditions

Bipolar I Depression Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham Psychiatry Pharmaceutical Studies, Inc., Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RG2417

Drug

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

Other names: Uridine

Placebo

Drug

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

Other names: Sugar Pill

Primary outcomes

  1. MADRS Score

    Time frame: Baseline and weekly for 8 weeks

Secondary outcomes

  1. CGI-BP-S

    Time frame: Baseline and weekly for 8 weeks

  2. 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

Sponsors and collaborators

Lead sponsor

Repligen Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 19, 2008
Registry last updated
Jan 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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