Safety and Efficacy Study in Patients With Major Depressive Disorder

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Depressive Disorder

Treatments: Drug: GSK163090 1 mg; Drug: GSK163090 Placebo; Drug: GSK163090 3 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00896363

109035

Details and patient eligibility

About

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.

Full 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 and tolerability will be assessed in three treatment arms. The study will consist of a screening period, a treatment phase (up to 6 weeks) and a post-treatment follow-up visit. The study duration from screening to follow up will be approximately 9 weeks. Subjects who pass screening will be randomized on Day 1 to one of three treatment arms (low dose arm, high dose arm or placebo). Each treatment arm will contain approximately 50 subjects. The subject's depressive symptoms will be assessed using the HAMD17- CR.

Enrollment: 99 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

Parallel Group - High Dose Arm, Low Dose Arm

Treatment:

Drug: GSK163090 1 mg

Drug: GSK163090 3 mg

Placebo

Placebo Comparator group

Description:

Parallel Group

Treatment:

Drug: GSK163090 Placebo