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CompletedNCT00545142SMART-AUpdated Jun 25, 2010

Abilify in Bipolar Disorder for 6 Weeks Treatment Effectiveness

A Phase 4 interventional study of Abilify(Aripiprazole) and Depakote(Divalproate) in Bipolar Disorder, sponsored by Korea Otsuka Pharmaceutical Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-06-25.

Sponsored by Korea Otsuka Pharmaceutical Co., Ltd. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
280
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Further study details as provided by Korea OIAA

02

Conditions studied

  • Bipolar Disorder

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03

In context

Bipolar Disorder

1,602 studies on the registry are indexed under Bipolar Disorder; 255 are open to participants now.

This study's planned enrollment of 280 is above the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 41 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
280 participants (estimated)

Interventions

  • DrugAbilify(Aripiprazole)

    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

06

What researchers measure

Primary outcomes

  1. Changes in the YMRS total score from baseline to the end of 6-week study

    Time frame: Throughout the study

Secondary outcomes

  1. Changes in YMRS total scores from baseline to the end of 6-week study

    Time frame: Throughout the study

07

Study locations

1 site
  • St. Mary's hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00545142
Lead sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
First posted
Oct 17, 2007
Start date
Oct 2007
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Jun 25, 2010

Study contacts

Won-Myong Bahk, MD
principal investigator · St Mary's Hospital, London

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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