Bipolar Disorder
Conditions
Brief summary
To demonstrate the efficacy and safety of co-administration of Abilify(aripiprazole) with Depakote(divalproate) in the acute phase of 6-week treatment of acute mania in patients with bipolar disorder.
Detailed description
Further study details as provided by Korea OIAA
Interventions
co-administration of Abilify with Depakote in the 6-week treatment of acute mania in patients with bipolar disorder
DRUGDepakote(Divalproate)
co-administration of Abilify with Depakote in the 6-week treatment of acute mania in patients with bipolar disorder
Sponsors
Korea Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the YMRS total score from baseline to the end of 6-week study | Throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| Changes in YMRS total scores from baseline to the end of 6-week study | Throughout the study |
Countries
South Korea
Outcome results
None listed