Last updated: 11/07/2018 02:33:18

Safety and Efficacy study in Patients with Major Depressive Disorder

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GSK study ID
109035
See study documents
Clinicaltrials.gov ID
NCT00896363
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

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

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

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

Number of participants with suicidal behavior and suicidal ideation subscales of the Columbia Suicide Severity Rating Scale (C-SSRS)

Timeframe: Up to Day 52

Number of participants with Abnormal hematology values of clinical concern range (CCR).

Timeframe: Up to Day 42

Number of participants with abnormal chemistry values of CCR

Timeframe: Up to Day 42

Change from Baseline in liver chemistry -Alkaline Phosphatase (ALP), ALT, AST and GGT

Timeframe: Baseline (screening) up to Day 42

Change from Baseline in liver chemistry- Direct Bilirubin and Total Bilirubin

Timeframe: Baseline (screening) up to Day 42

Number of participant of Urinanalysis assessment over period

Timeframe: Screening (Day -10 to -2), Day 14 and Day 42

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

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

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

Number of participants with all adverse events (AEs), and serious adverse events (SAEs)

Timeframe: Up to Day 52

Secondary outcomes:

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)

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)

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)

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)

Interventions:
  • Drug: GSK163090 1 mg
  • Drug: GSK163090 Placebo
  • Drug: GSK163090 3 mg
    • Enrollment:
    99
    Primary completion date:
    2010-09-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Depressive Disorder
    Product
    GSK163090
    Collaborators
    Not applicable
    Study date(s)
    April 2009 to February 2010
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 64 years
    Accepts healthy volunteers
    No
    • 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
    • Primary diagnosis of other psychiatric disorders
    • thoughts of killing ones self or someone else
    Inclusion and exclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Lipetsk Region, Russia, 399083
    Status
    Will Be Recruiting
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    Location
    GSK Investigational Site
    Moscow, Russia, 119992
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Investigational Site
    Saint Petersburg, Russia, 190005
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Investigational Site
    Ekaterinburg, Russia, 620030
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Saint-Petersburg, Russia
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Investigational Site
    St. Petersburg, Russia, 190121
    Status
    Will Be Recruiting
    Contact us
    Showing 1 - 6 of 15 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2010-09-02
    Actual study completion date
    2010-09-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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