Clinical trial NCT00896363: Safety and Efficacy Study in Patients With Major Depressive Disorder
Official title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder
Keywords: anti-depressant
Severe Depression
Efficacy
Major Depressive Disorder
Major Depressive Episode
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-05-11
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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

Primary outcomes:
measure: Change From Baseline in the Hamilton Depression Rating Scale (HAMD17), on Day 14 and 42
timeFrame: Baseline (Day 1, pre-dose), Day 14 and Day 42
measure: Change From Baseline in Bech Melancholia Subscale (BECH 6) Scale, on Day 14 and 42
timeFrame: Baseline (Day 1, pre-dose), Day 14 and Day 42
measure: Change From Baseline in Quick Inventory of Depressive Symtomatology - Self Rated (QIDS-SR) Scale, on Day 14 and 42
timeFrame: Baseline (Day 1, pre-dose), Day 14 and Day 42
measure: Number of Participants With Suicidal Behavior and Suicidal Ideation Subscales of the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to Day 52
measure: Number of Participants With Abnormal Hematology Values of Clinical Concern Range (CCR).
timeFrame: Up to Day 42
measure: Number of Participants With Abnormal Chemistry Values of CCR
timeFrame: Up to Day 42
measure: Change From Baseline in Liver Chemistry -Alkaline Phosphatase (ALP), ALT, AST and GGT
timeFrame: Baseline (screening) up to Day 42
measure: Change From Baseline in Liver Chemistry- Direct Bilirubin and Total Bilirubin
timeFrame: Baseline (screening) up to Day 42
measure: Number of Participant of Urinanalysis Assessment Over Period
timeFrame: Screening (Day -10 to -2), Day 14 and Day 42
measure: Change From Baseline in Electrocardiogram (ECG) Values -PR Interval, QRS Duration, QT Interval, QTcB, QTcF, RR Interval
timeFrame: Baseline (Day 1) and up to Day 42
measure: Mean of Change From Baseline in Systolic and Diastolic Blood Pressure (BP)
timeFrame: Baseline (Day 1) , Day 2, 3, 4, 5, 6, 7, 8, 14, 21, 28 and 42
measure: Mean of Change From Baseline in Heart Rate
timeFrame: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 14, 21, 28 and 42
measure: Number of Participants With All Adverse Events (AEs), and Serious Adverse Events (SAEs)
timeFrame: Up to Day 52
Secondary outcomes:
measure: Mean Last Observed Quantifiable Concentration (Ct) of GSK163090 Over the Period
timeFrame: Day 4 (AM pre-dose), Day 7 (AM and PM pre-dose), Day 10 (AM and PM pre-dose), Day 14 (AM and PM pre-dose), Day 21 (AM pre dose), Day 28 (AM pre dose), Day 42 (AM pre-dose and 4-6 h post AM dose)
measure: Area Under Concentration-time Curve (AUC) at Steady State
timeFrame: Day 4 (AM pre-dose), Day 7 (AM and PM pre-dose), Day 10 (AM and PM pre-dose), Day 14 (AM and PM pre-dose), Day 21 (AM pre dose), Day 28 (AM pre dose), Day 42 (AM pre-dose and 4-6 h post AM dose)
measure: Average Concentration (Cave) at Steady State
timeFrame: Day 4 (AM pre-dose), Day 7 (AM and PM pre-dose), Day 10 (AM and PM pre-dose), Day 14 (AM and PM pre-dose), Day 21 (AM pre dose), Day 28 (AM pre dose), Day 42 (AM pre-dose and 4-6 h post AM dose)
measure: Preliminary Pharmacokinetic/ Pharmacodynamic (PK/PD)Relationships for GSK163090 in Participants With MDD.
timeFrame: Day 4 (AM pre-dose), Day 7 (AM and PM pre-dose), Day 10 (AM and PM pre-dose), Day 14 (AM and PM pre-dose), Day 21 (AM pre dose), Day 28 (AM pre dose), Day 42 (AM pre-dose and 4-6 h post AM dose)
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Kemerovo
country: Russian Federation
facility: GSK Investigational Site
city: Lipetsk Region
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Nizhny Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saratov
country: Russian Federation
facility: GSK Investigational Site
city: Smolensk
country: Russian Federation
facility: GSK Investigational Site
city: St-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St.Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: