Bipolar DisorderPhase 4NCT00223496
12- Week Open Label Treatment of Refractory Bipolar Depression
A Phase 4 study testing Aripiprazole in people with Bipolar Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Aripiprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Sep 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- thyroid dysfunction
- unstable general medical condition
- require antipsychotic other than abilify
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ of Texas Helath Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: 12- Week Open Label Treatment of Refractory Bipolar Depression (BD) With Combination of Depakote ER (DEP) and Aripiprazole (AZP)
- Determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of DEP+AZP for a period of 12 weeks
- Determine the tolerability and safety of AZP added to DEP in the treatment of refractory bipolar depression
Read the 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
- Determine the tolerability and safety of AZP added to DEP in the treatment of refractory bipolar depression
- Conditions
- Bipolar Disorder
- Being tested
- Aripiprazole
- Keywords
- Bipolar Depression, Refractory
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole | Experimental | Aripiprazole open-label in doses ranging from 5-30mg QD adjunct to Divalproex 500-2500mg QD. Receives: Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Charles L. Bowden, The University of Texas Health Science Center at San Antonio
- Investigators
- Vivek Singh, MD, Principal investigator, University of TexasCharles L Bowden, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223496
- Sponsor's protocol ID
- 0340013419
- Status last verified
- Apr 2017
- First submitted
- 14 Sep 2005
- Last updated
- 16 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12- Week Open Label Treatment of Refractory Bipolar Depression (BD) With Combination of Depakote ER (DEP) and Aripiprazole (AZP)
- ClinicalTrials.gov ID
- NCT00223496
- Acronym / sponsor ID
- 0340013419
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Depression, Refractory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Sep 2004
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 21 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of DEP+AZP for a period of 12 weeks
- 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
- Determine the tolerability and safety of AZP added to DEP in the treatment of refractory bipolar depression
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | Experimental | Drug: AripiprazoleAripiprazole open-label in doses ranging from 5-30mg QD adjunct to Divalproex 500-2500mg QD. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AripiprazoleAripiprazole5mg - 30mg, every day (QD), for 12 weeks. | Drug | Aripiprazole |
Primary outcome
Primary Measure:Reduction in Depression Symptoms
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Singh, MD principal investigator
University of Texas
Charles L Bowden, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole in people with Bipolar Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Measure:Reduction in Depression Symptoms (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.