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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2010-09-02
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
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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
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Location
GSK Investigational Site
Saint Petersburg, Russia, 190005
Status
Will Be Recruiting
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Location
GSK Investigational Site
Ekaterinburg, Russia, 620030
Status
Study Complete
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Location
GSK Investigational Site
Saint-Petersburg, Russia
Status
Will Be Recruiting
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Location
GSK Investigational Site
St. Petersburg, Russia, 190121
Status
Will Be Recruiting
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Location
GSK Investigational Site
Tomsk, Russia, 634014
Status
Will Be Recruiting
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Location
GSK Investigational Site
Saratov, Russia, 410060
Status
Will Be Recruiting
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Location
GSK Investigational Site
St. Petersburg, Russia, 194044
Status
Study Complete
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Location
GSK Investigational Site
St.Petersburg, Russia, 193167
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Nizhny Novgorod, Russia, 603107
Status
Will Be Recruiting
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Location
GSK Investigational Site
Saint Petersburg, Russia, 191180
Status
Will Be Recruiting
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Location
GSK Investigational Site
Smolensk, Russia, 214 019
Status
Will Be Recruiting
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Location
GSK Investigational Site
Kemerovo, Russia, 650036
Status
Will Be Recruiting
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Location
GSK Investigational Site
St-Petersburg, Russia, 197341
Status
Will Be Recruiting
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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
Completed
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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