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
)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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.
Univ of Texas Helath Science Center at San Antonio
San Antonio, Texas, United States
Primary Measure:Reduction in Depression Symptoms
Primary efficacy will be assessed by the proportion of patients achieving a 50% reduction (range 0- 60, higher the number the more depressed) on the Montgomery Asberg Depression Rating Scale (MADRS) (defined as response) concomitant with a Clinical Global Impression Scale(CGI-S) improvement of 1 or 2 (range 0-7, higher the number the more severe the overall bipolar symptoms).
Time frame: up to 12 weeks
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