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Клинические исследования в Украине

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Исследования / № 01173601

Описание
Краткое названиеA Fixed Dose Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder
Полное названиеA Randomized, Placebo-Controlled, Double-Blind Study of LY2216684 Fixed-Dose 12 mg and 18 mg Once Daily as Adjunctive Treatment for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment
СпонсорEli Lilly and Company
Industry
ИсточникEli Lilly and Company
Под контролемUnited States: Food and Drug Administration
No
Краткое описаниеThe primary purpose of this study is to assess whether at least one dose of LY2216684 (12 mg
or 18 mg once daily) is superior to placebo once daily in the adjunctive treatment of
patients with major depressive disorder (MDD) who were identified as partial responders to
an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI), during
an 11-week, double-blind, acute adjunctive treatment phase.
СостояниеИдет набор
Дата началаNovember 2010
ФазаPhase 3
Вид исследованияAllocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

- Clinical diagnosis of Major Depressive Disorder (MDD)

- Women of child-bearing potential may participate but must test negative for pregnancy
at the time of study entry; both women/men agree to use a reliable method of birth
control

- Are taking an SSRI approved for MDD treatment within the patient's country and the
SSRI prescribed, including dose, should be consistent with labeling guidelines within
the participating country

- Have a partial response to SSRI treatment

- Meet inclusion scores on pre-defined psychiatric scales to assess diagnosis of
depression, disease severity, and response to SSRI treatment

- Reliable and able to keep all scheduled appointments

Exclusion Criteria:

- Presence of another primary psychiatric illness:

- Have had or currently have any additional ongoing Diagnostic and Statistical
Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Axis 1
condition other than major depression within 1 year of screening

- Have had any anxiety disorder that was considered a primary diagnosis within the
past year (including panic disorder, obsessive-compulsive disorder,
post-traumatic stress disorder, generalized anxiety disorder, and social phobia,
but excluding specific phobias)

- Have a current or previous diagnosis of a bipolar disorder, schizophrenia, or
other psychotic disorder

- Have a history of substance abuse and/or dependence within the past 1 year (drug
categories defined by DSM-IV-TR), not including caffeine and nicotine.

- Have an Axis II disorder that, in the judgment of the investigator, would
interfere with compliance with protocol

- Have any diagnosed medical condition which could be exacerbated by noradrenergic
agents including unstable hypertension, unstable heart disease, tachycardia,
tachyarrhythmia, narrow-angle glaucoma, urinary hesitation or retention

- Use of excluded concomitant or psychotropic medication other than SSRI

- Have initiated or discontinued hormone therapy within the previous 3 months of prior
to enrollment

- Have treatment resistant depression

- Have a lifetime history of vagal nerve stimulation, transcranial magnetic
stimulation, or psychosurgery

- Have received electroconvulsive therapy in the last year

- Enrollment in a clinical study for an investigational drug

- Serious or unstable medical condition

- History of seizure disorders

- Have initiated psychotherapy or other nondrug therapies (such as acupuncture or
hypnosis) within 12 weeks prior to enrollment or any time during the study. No change
in intensity of psychotherapy within the last 6 weeks prior to enrollment or at any
time during the study.

- Patients who, in the opinion of the investigator, are judged to be at serious risk
for harm to self or others
ПолBoth
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеMajor Depressive Disorder
Применяемое лечение
DrugLY2216684
DrugPlacebo
Контакты и расположение
Dnipropetrovsk , 49616For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or sp
Kherson , 73488For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or sp
Kiev , 2660For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or sp
Kyiv , 03049For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or sp
Lugansk , 91045For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or sp
Lviv , 79021For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or sp
Poltava , 36006For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or sp
Uzhorod , 88000For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or sp
Vinnytsya , 21005For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or sp
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