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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00545142 |
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Date of registration:
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16/10/2007 |
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Primary sponsor: |
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Public title:
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Abilify in Bipolar Disorder for 6 Weeks Treatment Effectiveness
SMART-A |
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Scientific title:
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Multi-center, Single Arm, Open Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of Abilify With Depakote in the 6-week Treatment of Acute Mania in Patients With Bipolar Disorder |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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280 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00545142 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Won-Myong Bahk, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Mary's Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Inclusion Criteria:
1. Mania or mixed episode of Bipolar disorder Bipolar disorder, mania or mixed episode
according to DSM-IV
2. The periods of mania or mixed episode should be within 3 months, and YMRS score at
enrollment be more than 20.
3. Male and female between the age of 18 and 65 (In case of child-bearing women,
negative pregnancy test results should be confirmed before the administration of the
investigational drug and appropriate contraception be used. Pregnant and
breast-feeding women cannot be included)
4. Patients who can consent to participate in this clinical trial
5. Patients who understand this trial and comply with all protocol requirements
Exclusion Criteria:
1. Patients with the following clinical symptoms diagnosed using DSM-IV:
- Delirium, dementia, amnestic or other cognitive disorders
- Schizophrenia or schizoaffective disorder
2. Patients who do not respond to clozapine
3. Patients who are expected to require the administration of prohibited concomitant
drugs during the clinical trial period
4. Patients diagnosed with substance-related disorder according to DSM-IV within the
past 3 months (abuse, intoxication, dependency and/or withdrawal symptoms). The abuse
of benzodiazepines is included with the exception of caffeine or nicotine.
5. Patients known to have allergy or hypersensitivity reaction to Ablify(aripiprazole)
or other quinolinones
6. Patients at high risk of suicide attempt or with the history of murder or mental
status test
7. Patients with the history of neuroleptic malignant syndrome
8. Patients with the past history which may cause serious adverse events that can affect
the safety or efficacy evaluation during the clinical trial period
9. Patients with vital sign or ECG results in the clinically significant abnormal
laboratory test Patients with clinically significantly abnormal laboratory results,
vital sign or ECG results
10. Pregnant women or child-bearing women who do not or cannot use appropriate
contraception
11. Patients given psychotropic medications (except benzodiazepines) one day before
baseline visit
12. Patients treated with Fluoxetine for the last 4 weeks
13. Patients who participated in clinical trials with other investigational drugs for the
last one month
14. Patients with the history of convulsive disorder
15. Patients with the history of more than 4 mood episodes each year (rapid cycling)
during the last 2 years prior to screening.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bipolar Disorder
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Intervention(s)
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Drug: Abilify(Aripiprazole)
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Drug: Depakote(Divalproate)
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Primary Outcome(s)
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Changes in the YMRS total score from baseline to the end of 6-week study
[Time Frame: Throughout the study]
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Secondary Outcome(s)
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Changes in YMRS total scores from baseline to the end of 6-week study
[Time Frame: Throughout the study]
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Secondary ID(s)
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031-KOB-0701
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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