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Sponsored by: |
Korea Otsuka Pharmaceutical Co.,Ltd. |
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Information provided by: | Korea Otsuka Pharmaceutical Co.,Ltd. |
ClinicalTrials.gov Identifier: | NCT00545675 |
To demonstrate the difference between Abilify with Depakote vs. Placebo with Depakote in 24-week treatment in patients with remission status after Abilify with Depakote in the 6-week study of acute mania in patients with bipolar disorder
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder |
Drug: Abilify(aripiprazole) Drug: Depakote (divalproate) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multi-Center, Double-Blind, Randomized, Comparative Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of co-Administration of Abilify and Depakote in 24-Week Treatment of Mania in Patients With Bipolar Disorder Remitted After 6-Week Treatment With Abilify and Depakote |
Estimated Enrollment: | 146 |
Study Start Date: | November 2007 |
Arms | Assigned Interventions |
---|---|
1: Experimental
Abilify(aripiprazole) + Depakote(divalproate)
|
Drug: Abilify(aripiprazole) Drug: Depakote (divalproate) |
2: Placebo Comparator
Divalproate + Placebo
|
Drug: Depakote (divalproate) |
Further study details as provided by Korea OIAA
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients with the following clinical symptoms diagnosed using DSM-1. Patients with the following clinical symptoms diagnosed using DSM-IV:
Contact: Yonghui Jeong | 82-(0)2-3465-3954 | jeongyh@otsuka.co.kr |
Contact: Heather Yoo | 82-(0)2-3451-6522 | heatheryoo@otsukaoiaa.com |
Korea, Republic of | |
St. Mary's Hospital | |
Seoul, Korea, Republic of |
Principal Investigator: | Won-Myong Bahk, MD | St. Mary's Hospital |
Study ID Numbers: | 031-KOB-0702 |
Study First Received: | October 16, 2007 |
Last Updated: | October 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00545675 History of Changes |
Health Authority: | Korea: IRB |
Neurotransmitter Agents Tranquilizing Agents Bipolar Disorder Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Antimanic Agents |
Valproic Acid Affective Disorders, Psychotic Mental Disorders Mood Disorders Psychotic Disorders Aripiprazole Anticonvulsants |
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Bipolar Disorder Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors Antipsychotic Agents Antimanic Agents |
Valproic Acid Pharmacologic Actions Affective Disorders, Psychotic Pathologic Processes Mental Disorders Therapeutic Uses Mood Disorders GABA Agents Aripiprazole Central Nervous System Agents Anticonvulsants |