Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The University of Texas Health Science Center at San Antonio
With
Bristol-Myers Squibb
)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
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
