Safety and Efficacy Study in Patients With Major Depressive Disorder
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: GSK163090 1 mg; GSK163090 Placebo; GSK163090 3 mg
Intervention description: Developed for the treatment of Major Depressive Disorder; Developed for the treatment of Major Depressive Disorder; Developed for the treatment of Major Depressive Disorder
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: anti-depressant; Severe Depression; Efficacy; Major Depressive Disorder; Major Depressive Episode

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 Russia in hospitalised patients with severe depression. GSK163090 will be
      compared with placebo, which looks like the study drug but does not contain any active
      substance. Subjects will be given either the study drug or the matching placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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