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Sponsored by: |
Korea Otsuka International Asia Arab |
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Information provided by: | Korea Otsuka International Asia Arab |
ClinicalTrials.gov Identifier: | NCT00484471 |
To compare combination treatment of aripiprazole plus valproate versus valproate alone in the prevention of relapse in bipolar I disorder patients with symptomatic remission after 5-6 weeks open-label acute treatment with aripiprazole plus valproate for manic or mixed episode, with or without psychotic features.
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder |
Drug: aripiprazole Drug: valproate Drug: placebo |
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: | A Double Blind, Randomized, Placebo Controlled Trial of Aripiprazole Plus Valproate in the Short-Term and Long-Term Treatment of Bipolar Disorder |
Estimated Enrollment: | 280 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: aripiprazole
15-30 mg/day aripiprazole, 22 weeks
Drug: valproate
sufficient dose as determined by investigator to maintain the therapeutic level.
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2: Placebo Comparator |
Drug: valproate
sufficient dose as determined by investigator to maintain the therapeutic level.
Drug: placebo
placebo to aripiprazole, 22 weeks
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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:
The following laboratory tests results, vital signs, and ECG findings are exclusionary:
Contact: YooHwa Song, MS | 82-3451-6532 | ysong@otsukaoiaa.com |
Contact: HyeJa Kim, MS | 82-3451-6531 | hyera18@otsukaoiaa.com |
Hong Kong | |
Castle Peak Hospital | Recruiting |
Tuen Mun, Hong Kong | |
Contact: F K Tsang, MD | |
Philippines | |
National Center for Mental Health | Recruiting |
Mandaluyong, Philippines | |
Contact: Efren Reyes, MD | |
Philippine General Hospital | Recruiting |
Manilla, Philippines | |
Contact: Rosanna de Guzman, MD | |
University of Sto. Tomas Hospital | Recruiting |
Manilla, Philippines | |
Contact: Gabino Ranoa, MD | |
Veterans Medical Memorial Center | Recruiting |
Quezon, Philippines | |
Contact: Amadeo Alinea, MD | |
Taiwan | |
Changhua Chrisitian Hospital | Recruiting |
Changhua, Taiwan | |
Contact: Nan-Ying Chiu, MD | |
Taoyuan Mental Hospital | Recruiting |
Taoyuan, Taiwan | |
Contact: Hun-Yu Chang, MD | |
National Cheng-Kung University Hospital | Recruiting |
Tainan, Taiwan | |
Contact: Yen-Kung Yang, MD | |
Jia-Nan Mental Hospital | Recruiting |
Tainan, Taiwan | |
Contact: Wen-Chen Ouyang, MD | |
Tri-Service General Hospital | Recruiting |
Taipei, Taiwan | |
Contact: Wei-Wen Li, MD | |
Tsao-Tun Psychiatric Center | Recruiting |
Nantou, Taiwan | |
Contact: Tso-Ren Wang, MD | |
Thailand | |
Somdej Chaophraya Hospital | Recruiting |
Bangkok, Thailand | |
Contact: Vasu Chantarasak, MD | |
Siriraj Hospital | Recruiting |
Bangkok, Thailand | |
Contact: Suttiporn Janenawasin, MD |
Study Chair: | Nan-Ying Chiu, MD | Changhua Christian Hospital, Taiwan |
Principal Investigator: | Hun-Yu Chang, MD | Taoyuan Mental Hospital |
Principal Investigator: | Yen-Kung Yang, MD | National Cheng-Kung University Hospital |
Principal Investigator: | Wen-Chen Ouyang, MD | Jia-Nan Mental Hospital |
Principal Investigator: | Wei-Wen Lin, MD | Tri-Service General Hospital |
Principal Investigator: | Tso-Ren Wang, MD | Tsao-Tun Psychistric Center |
Principal Investigator: | Efren Reyes, MD | National Center for Mental Health (NCMH) |
Principal Investigator: | Rosanna de Guzman, MD | Philippine General Hospital (PGH) |
Principal Investigator: | Gabino Ranoa, MD | University of Sto. Tomas Hospital (USTH) |
Principal Investigator: | Amadeo Alinea | Veterans Medical Memorial Center (VMMC) |
Principal Investigator: | .Vasu Chantarasak, MD | Somdej Chaophraya Hospital |
Principal Investigator: | Suttiporn Janenawasin, MD | Siriraj Hospital |
Principal Investigator: | F K Tsang, MD | Castle Peak Hospital |
Responsible Party: | Korea Otsuka International Asia Arab ( Korea Otsuka International Asia Arab ) |
Study ID Numbers: | 031-OTB-0701 |
Study First Received: | June 8, 2007 |
Last Updated: | May 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00484471 History of Changes |
Health Authority: | Taiwan: Institutional Review Board; Philippines: Ethics Committee; Thailand: Ethical Committee; Hong Kong: Ethics Committee |
Neurotransmitter Agents Tranquilizing Agents Bipolar Disorder Benzocaine 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 |