Phase 4
N=32
12- Week Open Label Treatment of Refractory Bipolar Depression
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00223496 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Primary Measure:Reduction in Depression Symptoms — 16 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aripiprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Measure:Reduction in Depression Symptoms |
16 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00223496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.