Bipolar Disorder
Conditions
Keywords
Bipolar Depression, Refractory
Brief summary
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
Detailed description
)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
Interventions
DRUGAripiprazole
Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.
Sponsors
Bristol-Myers Squibb
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Measure:Reduction in Depression Symptoms | up to 12 weeks | 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). |
Countries
United States
Participant flow
Recruitment details
Recruitment from March 2006 to June 2009 from clinic patients and those responding to public advertisements.
Pre-assignment details
Subjects who entered study in a bipolar depressed state were started on divalproex ER. Those still depressed, according to depression rating scales, after visit 4 were given aripiprazole in addition to divalproex ER.
Participants by arm
| Arm | Count |
|---|---|
| Aripiprazole Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 6 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Physician Decision | 2 |
| Overall Study | screen failure | 9 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Aripiprazole |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 41 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 16 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aripiprazole Plus Divalalproex ER | Primary Measure:Reduction in Depression Symptoms | 16 participants |