Status:
COMPLETED
Safety and Efficacy Study in Patients With Major Depressive Disorder
Lead Sponsor:
GlaxoSmithKline
Conditions:
Depressive Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test if GSK163090 can reduce the symptoms of depression. The safety and how well the body can handle the drug will also be investigated. The study will be conducted in ...
Detailed Description
This is a randomised, multi-centre, double-blind, placebo-controlled, repeat dose, parallel group study in male and female patients with severe depression requiring hospitalization. Efficacy, safety a...
Eligibility Criteria
Inclusion
- Currently have severe depression (Major Depressive Disorder - without psychotic features)
- meet criteria (DSM IV-TR ) for current major depressive episode for at least 4 weeks but for no greater than 24 months
- depression questionnaire (HAMD17) total score greater than or equal to 24
- subject must read and able to give written informed consent
- male or female 18 to 64 years
- use appropriate birth control method
- BMI 18.8 - 35.0 kg/m2 (inclusive)
Exclusion
- Primary diagnosis of other psychiatric disorders
- thoughts of killing ones self or someone else
- taking psychiatric medicine or therapy within the six months
- Has previously failed an adequate course of medication for MDD from two different classes of antidepressants.
- Unstable medical disorder or a disorder that would interfere with the action of the drug
- Abuse of alcohol or drugs
- Past history of serotonin syndrome or a history of clinical significant intolerance of SSRIs (class of drugs used for depression).
- History of migraine headaches that respond to treatment with triptan medication.
- History of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (excluding febrile seizure).
- Currently taking part in another clinical study or has done so within six months
- Pregnant, planning to become pregnant shortly or breastfeeding
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy
Key Trial Info
Start Date :
April 23 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2010
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00896363
Start Date
April 23 2009
End Date
February 9 2010
Last Update
March 19 2018
Active Locations (15)
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1
GSK Investigational Site
Kemerovo, Russia, 650036
2
GSK Investigational Site
Lipetsk Region, Russia, 399083
3
GSK Investigational Site
Moscow, Russia, 119992
4
GSK Investigational Site
Nizhny Novgorod, Russia, 603107