A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression - NCT00812058-21205 (Clinical Trial 261448)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy261448.aspx
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Baltimore |
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State:
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MD |
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21205 |
| Conditions: |
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Bipolar I Depression |
| Purpose: |
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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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| Study summary: |
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| Criteria: |
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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 |
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| Study is available at: |
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Johns Hopkins School of Medicine
Baltimore, MD 21205
United States
Primary Contact:
Andrea Galatis
Email: agalati1@jhmi.edu
Phone: 410-502-2334 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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