12- Week Open Label Treatment of Refractory Bipolar Depression

Bipolar Disorder Clinical Trial

Official title:

12- Week Open Label Treatment of Refractory Bipolar Depression (BD) With Combination of Depakote ER (DEP) and Aripiprazole (AZP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223496
• Other study ID #: 0340013419
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: April 9, 2013
• Start date: September 2004
• Est. completion date: September 2009

Study information

• Verified date: April 2013
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Aripiprazole
Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.

Locations

Country	Name	City	State
United States	Univ of Texas Helath Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	up to 12 weeks	No