12- Week Open Label Treatment of Refractory Bipolar Depression
Completed · Phase 4
Conditions studied: Bipolar Disorder
In brief
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
Key facts
- Study ID
- NCT00223496
- Run by
- The University of Texas Health Science Center at San Antonio
- People needed
- 32
- Starts
- 2004-09-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2017-05-16
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- diagnosis of bipolar disorder I or II according to M.I.N.I.
- 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 more than 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
You may not qualify if…
- current liver disease,
- illness precluding the use of depakote er
- 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 abilify
Where it is running
- Univ of Texas Helath Science Center at San Antonio — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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