Bipolar DepressionPhase 4NCT00198198
Aripiprazole Treatment of Bipolar Depression
A Phase 4 study testing Aripiprazole in people with Bipolar Depression, run by Indiana University at 1 site in United States.
Trial summary
This is a study of addition of aripirazole to the treatment of bipolar depressed patients who are not better on the medications that they are currently receiving. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Aripiprazole
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Nov 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Male or female between 18 - 65 years of age, inclusive 2) Satisfy DSM-IV criteria for bipolar disorder depressed phase i.e.,duration of depression > 2 weeks) 3) No change in psychotropic medication or their doses within 2 weeks of inclusion in The study. 4) Inadequately responsive to or intolerant of prior pharmacotherapy as determined by the investigator 5) 17-item Hamilton Depression Rating Scale Score > 15 6) Young Mania Rating Scale (Young, et. al., 1978) (YMRS) < 10.
Who cannot join
- Exclusion Criteria: 1) History of or currently suffering from serious medical illness, or be on medication that may interact with aripiprazole 2) On any other neuroleptic e.g., olanzapine, risperidone, ziprasidone, haloperidol.
- 3) History of substance abuse within 3 months or substance dependence within 6 months of the study. 4) Pregnant or planning to be pregnant or not using adequate contraception. 5) Received electroconvulsive therapy (ECT) treatment in the past 1 year. 6) Significant suicide or homicide risk at the time of the study; 7) Not on any herbal or any other alternative pharmacological treatment. 8) Renal or hepatic dysfunction 9) History of decreased sweating or heat stroke.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
UH 3124 University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Open Label Pilot Study of Aripiprazole Treatment of Difficult to Treat Bipolar Depression
This is a study of addition of aripirazole to the treatment of bipolar depressed patients who are not better on the medications that they are currently receiving.
Read the detailed description
Hypothesis/Objectives:
Aim 1: To investigate whether aripiprazole is effective in the treatment of bipolar depression.
Hypothesis 1: Aripiprazole will lead to a significant decrease in scores on the Hamilton Depression Rating Scale (HAM-D) during an 8-week treatment course.
- Study Population:
A total number of 10 evaluable patients will be enrolled in the study.
- Study Design and Method
This proposal will use an open label design. Aripiprazole will be added to the treatment of patients with DSM-IV (American Psychiatric Association, 1994) BDD. Patients will be allowed to continue their psychotropic medication, at a stable dose, as long as they meet inclusion criteria as described below. Aripiprazole will be started at a dose of 10 mg for two weeks, 15 mg for an additional two weeks, and 20 mg for the last four weeks. The length of time a patient stays on the maximum dose (20 mg) depends upon the patient's tolerance and treatment response. Treatment will continue for 8 weeks with weekly visits and ratings on the 17-item Hamilton Depression Rating Scale (HAM-D 17) and other ratings scales.
- Conditions
- Bipolar Depression
- Being tested
- Aripiprazole
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Investigators
- Amit Anand, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198198
- Sponsor's protocol ID
- 69883
- Other IDs
- 0402-46
- Status last verified
- Apr 2007
- First submitted
- 14 Sep 2005
- Last updated
- 5 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Pilot Study of Aripiprazole Treatment of Difficult to Treat Bipolar Depression
- ClinicalTrials.gov ID
- NCT00198198
- Acronym / sponsor ID
- 69883
- Conditions
- Bipolar Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Nov 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of addition of aripirazole to the treatment of bipolar depressed patients who are not better on the medications that they are currently receiving.
Detailed description
Hypothesis/Objectives:
Aim 1: To investigate whether aripiprazole is effective in the treatment of bipolar depression.
Hypothesis 1: Aripiprazole will lead to a significant decrease in scores on the Hamilton Depression Rating Scale (HAM-D) during an 8-week treatment course.
- Study Population:
A total number of 10 evaluable patients will be enrolled in the study.
- Study Design and Method
This proposal will use an open label design. Aripiprazole will be added to the treatment of patients with DSM-IV (American Psychiatric Association, 1994) BDD. Patients will be allowed to continue their psychotropic medication, at a stable dose, as long as they meet inclusion criteria as described below. Aripiprazole will be started at a dose of 10 mg for two weeks, 15 mg for an additional two weeks, and 20 mg for the last four weeks. The length of time a patient stays on the maximum dose (20 mg) depends upon the patient's tolerance and treatment response. Treatment will continue for 8 weeks with weekly visits and ratings on the 17-item Hamilton Depression Rating Scale (HAM-D 17) and other ratings scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Male or female between 18 - 65 years of age, inclusive 2) Satisfy DSM-IV criteria for bipolar disorder depressed phase i.e.,duration of depression > 2 weeks) 3) No change in psychotropic medication or their doses within 2 weeks of inclusion in The study. 4) Inadequately responsive to or intolerant of prior pharmacotherapy as determined by the investigator 5) 17-item Hamilton Depression Rating Scale Score > 15 6) Young Mania Rating Scale (Young, et. al., 1978) (YMRS) < 10.
Key exclusion criteria (3 listed)
- Exclusion Criteria: 1) History of or currently suffering from serious medical illness, or be on medication that may interact with aripiprazole 2) On any other neuroleptic e.g., olanzapine, risperidone, ziprasidone, haloperidol.
- 3) History of substance abuse within 3 months or substance dependence within 6 months of the study. 4) Pregnant or planning to be pregnant or not using adequate contraception. 5) Received electroconvulsive therapy (ECT) treatment in the past 1 year. 6) Significant suicide or homicide risk at the time of the study; 7) Not on any herbal or any other alternative pharmacological treatment. 8) Renal or hepatic dysfunction 9) History of decreased sweating or heat stroke.
- -
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 |
|---|---|---|
| Aripiprazole | Drug | – |
Primary outcome
Hamilton Depression Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2007.
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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.
Amit Anand, MD principal investigator
Indiana University
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 Depression, run by Indiana University 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 1 inclusion and 3 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 5 Apr 2007. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hamilton Depression Scale. 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 5 Apr 2007.