Safety and Efficacy Study in Patients With Major Depressive Disorder - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by (Responsible Party):	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00896363

Purpose

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.

Condition	Intervention	Phase
Depressive Disorder Major Depressive Disorder (MDD) Major Depressive Episode	Drug: GSK163090 Tablets Drug: GSK163090 Placebo Tablets	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Efficacy - To evaluate the antidepressant efficacy of GSK163090 versus placebo in the treatment of subjects diagnosed with Major Depressive Disorder (MDD) during the first 2 weeks of treatment. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Efficacy - To evaluate the antidepressant efficacy of GSK163090 versus placebo in the treatment of subjects diagnosed with Major Depressive Disorder (MDD) after 6 weeks of treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Safety and Tolerability - To assess the safety and tolerability of GSK163090 compared to placebo in subjects diagnosed with MDD. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To investigate preliminary pharmacokinetic/pharmacodynamic relationships for GSK163090 in subjects with MDD. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	99
Study Start Date:	April 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Active Parallel Group - High Dose Arm, Low Dose Arm	Drug: GSK163090 Tablets Developed for the treatment of Major Depressive Disorder
Placebo Comparator: Placebo Parallel Group	Drug: GSK163090 Placebo Tablets Developed for the treatment of Major Depressive Disorder

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896363

Locations

Russian Federation
GSK Investigational Site
Ekaterinburg, Russian Federation, 620030
GSK Investigational Site
Kemerovo, Russian Federation, 650036
GSK Investigational Site
Lipetsk Region, Russian Federation, 399083
GSK Investigational Site
Moscow, Russian Federation, 119992
GSK Investigational Site
Nizhny Novgorod, Russian Federation, 603107
GSK Investigational Site
Saint Petersburg, Russian Federation, 190005
GSK Investigational Site
Saint Petersburg, Russian Federation, 191180
GSK Investigational Site
Saint-Petersburg, Russian Federation
GSK Investigational Site
Saratov, Russian Federation, 410060
GSK Investigational Site
Smolensk, Russian Federation, 214 019
GSK Investigational Site
St-Petersburg, Russian Federation, 197341
GSK Investigational Site
St. Petersburg, Russian Federation, 190121
GSK Investigational Site
St. Petersburg, Russian Federation, 194044
GSK Investigational Site
Tomsk, Russian Federation, 634014

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00896363 History of Changes
Other Study ID Numbers:	109035
Study First Received:	May 7, 2009
Last Updated:	March 29, 2012
Health Authority:	Russia: Russian Ministry of Health

Keywords provided by GlaxoSmithKline:

anti-depressant
Severe Depression
Efficacy
Major Depressive Disorder
Major Depressive Episode

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major

Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 24, 2012