Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder
NCT ID: NCT00665366
Last Updated: 2013-12-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
493 participants
INTERVENTIONAL
2008-06-30
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo + valproate or lithium
Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
Placebo
Tablets, Oral, 0 mg, once daily, 12 weeks
Lithium
Participant's ongoing dose
Valproate
Participant's ongoing dose
Aripiprazole + valproate or lithium
Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
Aripiprazole
5-, 10-, or 15-mg oral tablets in titrated doses for 12 weeks
Lithium
Participant's ongoing dose
Valproate
Participant's ongoing dose
Interventions
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Aripiprazole
5-, 10-, or 15-mg oral tablets in titrated doses for 12 weeks
Placebo
Tablets, Oral, 0 mg, once daily, 12 weeks
Lithium
Participant's ongoing dose
Valproate
Participant's ongoing dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current ongoing lithium or valproate treatment with the possibility of benefiting, based on the investigator's clinical judgment, from adjunctive treatment with aripiprazole
* Therapeutic serum levels of lithium or valproate and a Young Mania Rating Total Score of 16 or higher at screening and baseline
* Participants taking current lithium or valproate treatment combined with antipsychotic medication other than aripiprazole are acceptable, provided that the other antipsychotic medication is washed out at least 3 days prior to the blood draw for therapeutic plasma levels of lithium and valproate determination. Long-acting antipsychotics must be washed out prior to entering the double-blind treatment.
Exclusion Criteria
* A diagnosis of delirium, dementia, amnesia or other cognitive disorder, or a psychotic disorder
* Current diagnosis of delirium, dementia, a cognitive disorder (ie, amnesia), or a psychotic disorder (ie, schizophrenia or schizoaffective disorder)
* Current diagnosis of bipolar II disorder, bipolar disorder not otherwise specified, or any other primary psychiatric disorder other than bipolar I disorder mania
* Thyroid pathology
* Demonstrated cocaine abuse or dependence within the past 3 months prior to screening.
* History of neuroleptic malignant syndrome from antipsychotic agents
* Manic symptoms that investigator considers refractory to treatment
* Previous nonresponsive (by investigator judgment) to aripiprazole for manic symptoms
* Significant risk of suicide based on history, mental status exam, or investigator judgment.
18 Years
ALL
No
Sponsors
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Otsuka America Pharmaceutical
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Salzburg, , Austria
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Vienna, , Austria
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Hradec Králové, , Czechia
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Litoměřice, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Beaupuy, , France
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Brumath, , France
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Château-Gontier, , France
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Clermont-Ferrand, , France
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Dijon, , France
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Dole, , France
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Jonzac, , France
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Le Vésinet, , France
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Montpellier, , France
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Nîmes, , France
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Paris, , France
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Reims, , France
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Saint-Nazaire, , France
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Sotteville-lès-Rouen, , France
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Strasbourg, , France
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Ellwangen, , Germany
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Ostfildern, , Germany
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Athens, , Greece
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Leros, , Greece
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Nea Ionia-Athens, , Greece
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Tripoli, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Győr, , Hungary
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Gyula, , Hungary
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Campobasso, , Italy
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Foggia, , Italy
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Foligno (Pg), , Italy
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Genova, , Italy
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La Spezia, , Italy
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Milan, , Italy
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Napoli, , Italy
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Pisa, , Italy
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Roma, , Italy
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Roma, , Italy
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Sant'Arsenio (Salerno), , Italy
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Choroszcz, , Poland
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Gdansk, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Poznan, , Poland
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Swiecie N/Wisla, , Poland
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Bucharest, , Romania
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Cluj-Nappoca, , Romania
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Iași, , Romania
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Khot'kovo, , Russia
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Krasnodar, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Tomsk, , Russia
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Johannesburg, Gauteng, South Africa
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Soweto, Gauteng, South Africa
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Vereeniging, Gauteng, South Africa
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Pinetown, KwaZulu-Natal, South Africa
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Cape Town, Western Cape, South Africa
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Barcelona, , Spain
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Madrid, , Spain
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Murcia, , Spain
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Denizli, , Turkey (Türkiye)
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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EudraCT number 2007-005959-42
Identifier Type: -
Identifier Source: secondary_id
CN138-502
Identifier Type: -
Identifier Source: org_study_id