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

NCT00812058 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2011-01-17

No results posted yet for this study

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.

Conditions

  • Bipolar I Depression

Interventions

DRUG

RG2417

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Repligen Corporation

    lead INDUSTRY

Principal Investigators

  • Gary Sachs, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00812058 on ClinicalTrials.gov