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Краткое названиеSafety and Efficacy of Cariprazine for Bipolar I Disorder
Полное названиеA Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder
СпонсорForest Laboratories
ИсточникForest Laboratories
Под контролемUnited States: Food and Drug Administration
Lithuania: State Medicine Control Agency - Ministry of Health
Croatia: Agency for Medicinal Product and Medical Devices
Ukraine: State Pharmacological Center - Ministry of Health
Russia: Ministry of Health and Social Development of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Romania: National Medicines Agency
Краткое описаниеThe objective of this study is to evaluate the efficacy, safety, and tolerability of
cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes
associated with bipolar I disorder.
СостояниеИдет набор
Дата началаJanuary 2010
ФазаPhase 3
Вид исследованияAllocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
КритерииInclusion Criteria:

- Patients who have provided informed consent prior to any study specific procedures

- Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as
confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual
of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without
psychotic symptoms

- Voluntarily hospitalized for current manic episode

- Patients with normal physical examination, laboratory, vital signs,and/ or
electrocardiogram (ECG)

Exclusion Criteria:

- Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I
disorder that was the primary focus of treatment within the previous six months
Минимальный возраст18 Years
Максимальный возраст65 Years
Применяемое лечение
DrugCariprazine low dose
DrugCariprazine high dose
Контакты и расположение
Dnipropetrovsk , 49027Forest Investigative Site 308
Donetsk , 83008Forest Investigative Site 301
Kharkiv , 61068Forest Investigative Site 307
Kharkiv , 61068Forest Investigative Site 310
Kyiv , 04080Forest Investigative Site 303
Kyiv , 01030Forest Investigative Site 304
Kyiv , 02660Forest Investigative Site 305
Kyiv , 04080Forest Investigative Site 309
Kyiv , 08631Forest Investigative Site 312
Lugansk , 91045Forest Investigative Site 306
Lviv , 79021Forest Investigative Site 311
Odessa , 65006Forest Investigative Site 302
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