View Clinical Trial (Medical Research Study)
12- Week Open Label Treatment of Refractory Bipolar Depression - NCT00223496-78229(Clinical Trial 130986)
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| City: |
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San Antonio |
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State:
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TX |
| Zip Code: |
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78229 |
| Conditions: |
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Bipolar Disorder |
| Purpose: |
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1. Determine the change in symptomatology and function in refractory bipolar depression,
when treated with combination of DEP+AZP for a period of 12 weeks
2. Determine the tolerability and safety of AZP added to DEP in the treatment of
refractory bipolar depression
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| Study summary: |
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)Determine the change in symptomatology and function in refractory bipolar depression, when
treated with combination of DEP+AZP for a period of 12 weeks
2) Determine the tolerability and safety of AZP added to DEP in the treatment of refractory
bipolar depression |
| Criteria: |
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Inclusion Criteria:
- diagnosis of bipolar disorder I or II according to MINI
- patient has signed informed consent
- male, or female who is using effective birth control if of child bearing age
- age 18 and above
- currently in a depressed phase, with or without psychotic features, of the illness
based on DSM-IV/MINI criteria
- score of 19 on the MADRS
- history of treatment refractory bipolar depression as defined by failure of the
depressive episode to respond to a mood stabilizer alone or a combination of 2 or
more mood stabilizers or a combination of a mood stabilizer and an antidepressant
Exclusion Criteria:
- current liver disease,
- illness precluding the use of DEP
- patients who have been treated with a DEP and AZP combination in the past
- Alcohol/drug dependence in the past one month
- CNS neoplasms, demyelinating diseases, degenerative neurological condition or active
CNS infection
- history of seizure, known EEG with frank paroxysmal activity, known CT of brain
showing gross structural abnormalities, cerebral vascular disease by history or
structural brain damage from trauma
- thyroid dysfunction
- unstable general medical condition
- require antipsychotic other than AZP |
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| Study is available at: |
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Univ of Texas Helath Science Center at San Antonio
San Antonio, TX 78229
United States
Primary Contact:
Martha - Dahl, RN
Email: dahlml@uthscsa.edu
Phone: 210-567-5501 |
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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 21, 2011 |
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