CompletedNCT00665366
Aripiprazole or placebo added to lithium or valproate for mania in bipolarity type I
About this title
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
Read the official source — NCT00665366This study evaluated the safety and effectiveness of Aripiprazole for people with bipolarity.
Medication studyAges 18+Multiple countries
Understand this study
What did researchers investigate?
This study evaluated the safety and effectiveness of Aripiprazole for people with bipolarity.
Who was this study for?
This study was for people with bipolarity. Listed age limits: from 18 years. Other eligibility criteria applied.
- Listed locations
- Salzburg and 72 more locationsSee all locations and recruitment
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Study information
Study start dateJune 2008
- Recruitment status
- Completed
- Enrollment listed in the registry
- 493
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Sponsor type
- Pharmaceutical company
- Study type
- Drug
- Intervention type
- Medication / drug
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
- Locations
- France, Austria, Czechia, ...
- Age range
- Over 18 Years
- Official registry ID
- NCT00665366
- Official title
Show the full official title
A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated on Valproate or Lithium and in Need of Further Clinical Improvement
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Explore recruiting studiesRecruitment & locations
CompletedSalzburg, Austria · Vienna, Austria · Hradec Králové, Czechia
65 more locations
- Litoměřice, Czechia
- Prague, Czechia
- Beaupuy, France
- Brumath, France
- Château-Gontier, France
- Clermont-Ferrand, France
- Dijon, France
- Dole, France
- Jonzac, France
- Le Vésinet, France
- Montpellier, France
- Nîmes, France
- Paris, France
- Reims, France
- Saint-Nazaire, France
- Sotteville-lès-Rouen, France
- Strasbourg, France
- Ellwangen, Germany
- Ostfildern, Germany
- Athens, Greece
- Leros, Greece
- Nea Ionia-Athens, Greece
- Tripoli, Greece
- Budapest, Hungary
- Győr, Hungary
- Gyula, Hungary
- Campobasso, Italy
- Foggia, Italy
- Foligno (Pg), Italy
- Genova, Italy
- La Spezia, Italy
- Milan, Italy
- Naples, Italy
- Pisa, Italy
- Roma, Italy
- Sant'Arsenio (Salerno), Italy
- Choroszcz, Poland
- Gdansk, Poland
- Krakow, Poland
- Poznan, Poland
- Swiecie N/Wisla, Poland
- Bucharest, Romania
- Cluj-Nappoca, Romania
- Iași, Romania
- Khot'kovo, Russia
- Krasnodar, Russia
- Moscow, Russia
- Rostov-on-Don, Russia
- Saint Petersburg, Russia
- Samara, Russia
- Tomsk, Russia
- Johannesburg, South Africa
- Soweto, South Africa
- Vereeniging, South Africa
- Pinetown, South Africa
- Cape Town, South Africa
- Barcelona, Spain
- Madrid, Spain
- Murcia, Spain
- Ankara, Türkiye
- Antalya, Türkiye
- Denizli, Türkiye
- Czechia
- Russia
- Türkiye
Questions about this study
What did researchers investigate?
This study evaluated the safety and effectiveness of Aripiprazole for people with bipolarity.
Who is behind this study?
The study sponsor is Otsuka Pharmaceutical Development & Commercialization, Inc., a pharmaceutical company.
Did this study involve medication?
Yes. The study involved medication, including Aripiprazole, Placebo, lithium and valproate.
Who was this study for?
This study was for people with bipolarity. Listed age limits: from 18 years. Other eligibility criteria applied.
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