Adults 18 to 64, any sex, with Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in the Hamilton Depression Rating Scale (HAMD17), on Day 14 and 42Primary· Baseline (Day 1, pre-dose), Day 14 and Day 42
HAMD-17 is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items were rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17score ranges from 0 (not ill) to 52 (severely ill). The highest possible score was 52, which represented the most severe measure of depression; the
DAY 14
Group
Value
95% CI
Placebo
-10.9
± 6.02
GSK163090 1 mg
-10.8
± 5.68
GSK163090 3 mg
-10.3
± 5.95
DAY 42
Group
Value
95% CI
Placebo
-18.6
± 8.21
GSK163090 1 mg
-18.4
± 6.54
GSK163090 3 mg
-16.7
± 8.11
Change From Baseline in Bech Melancholia Subscale (BECH 6) Scale, on Day 14 and 42Primary· Baseline (Day 1, pre-dose), Day 14 and Day 42
The bech melancholia is sum of scores on 6 items- depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, somatic symptoms general (items 1, 2, 7, 8, 10 and 13 respectively). Each item having 5 responses. The items are rated on a scale of 0-4, where 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. Total possible score is 0-24. where the lowest possible score was 0, which represented an absence of depression and higher scores reflecting greater severity of diseases. Baseline was defined as the assessment done on Day 1. Change f
DAY 14
Group
Value
95% CI
Placebo
-4.9
± 3.14
GSK163090 1 mg
-4.6
± 2.85
GSK163090 3 mg
-4.2
± 3.33
DAY 42
Group
Value
95% CI
Placebo
-8.7
± 4.19
GSK163090 1 mg
-8.4
± 3.30
GSK163090 3 mg
-7.8
± 4.36
Change From Baseline in Quick Inventory of Depressive Symtomatology - Self Rated (QIDS-SR) Scale, on Day 14 and 42Primary· Baseline (Day 1, pre-dose), Day 14 and Day 42
The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle, and late insomnia or hypersomnia), appetite/weight increase/decrease and psychomotor agitation/retardation. A total score was obtained by summing scores on each domain. the scores ranges from 0 (none) to 27 (very severe), where the highest possible score was 27, which represented the most severe measure of depression; the lowest possible score was 0,
Day 14
Group
Value
95% CI
Placebo
-6.2
± 3.40
GSK163090 1 mg
-6.1
± 4.19
GSK163090 3 mg
-6.5
± 3.96
DAY 42
Group
Value
95% CI
Placebo
-11.0
± 4.75
GSK163090 1 mg
-11.4
± 4.32
GSK163090 3 mg
-10.8
± 4.57
Number of Participants With Suicidal Behavior and Suicidal Ideation Subscales of the Columbia Suicide Severity Rating Scale (C-SSRS)Primary· Up to Day 52
The C-SSRS was a clinician-rated scale that evaluated severity and change of suicidality by integrating both behaviour and ideation. The 2 of 3 sections of the scale were suicidal behavior and suicidal ideation. For suicidal behaviour participants were scored as non-suicidal-0, preparatory acts or behavior communicating ideation-01, aborted attempt-2, interrupted attempt-3 or actual attempt-4. The score ranges from 0-4, where 0 was absence of suicidal behavior and 4 being the most severe form of suicidal behavior. On the Suicidal Ideation scale, participants were scored as non-suicidal-0, wish
suicidal behavior
Group
Value
95% CI
Placebo
0
GSK163090 1 mg
0
GSK163090 3 mg
0
suicidal ideation,Day1,Wish to be dead
Group
Value
95% CI
Placebo
7
GSK163090 1 mg
5
GSK163090 3 mg
4
suicidal ideation,Day14,Wish to be dead
Group
Value
95% CI
Placebo
1
GSK163090 1 mg
1
GSK163090 3 mg
1
Number of Participants With Abnormal Hematology Values of Clinical Concern Range (CCR).Primary· Up to Day 42
Only those parameters for which at least one value of CC was reported were summarized. Pre-defined limits of CC (CC Low \[relative to the lower limit of normal\], CC High \[relative to the upper limit of normal\]) were: hemoglobin (Hb): \> 25, 180; hematocrit (Hct): \> 0.075, 0.54; absolute neutrophil count (ANC): \< 1.5, NA; platelet: \< 100, \> 550; white blood cells (WBC): \< 3,\> 20
Hb,screening, Low
Group
Value
95% CI
Placebo
2
GSK163090 1 mg
0
GSK163090 3 mg
0
Hb,Day 14, Low
Group
Value
95% CI
Placebo
2
GSK163090 1 mg
0
GSK163090 3 mg
0
Hct,screening, Low
Group
Value
95% CI
Placebo
2
GSK163090 1 mg
0
GSK163090 3 mg
0
ANC,screening, Low
Group
Value
95% CI
Placebo
1
GSK163090 1 mg
0
GSK163090 3 mg
0
ANC,Day14, Low
Group
Value
95% CI
Placebo
1
GSK163090 1 mg
1
GSK163090 3 mg
1
ANC,Day42, Low
Group
Value
95% CI
Placebo
1
GSK163090 1 mg
0
GSK163090 3 mg
1
Platelet,screening, High
Group
Value
95% CI
Placebo
1
GSK163090 1 mg
0
GSK163090 3 mg
0
Platelet,Day 14, High
Group
Value
95% CI
Placebo
1
GSK163090 1 mg
0
GSK163090 3 mg
0
Number of Participants With Abnormal Chemistry Values of CCRPrimary· Up to Day 42
Only those parameters for which at least one value of CC was reported were summarized. Pre-defined limits of CC (CC Low \[relative to the lower limit of normal\], CC High \[relative to the upper limit of normal\]) were: albumin (unit: gram per liter): \< 30, NA; alanine aminotransferase (ALT): NA, \>= 3 times upper limit of normal; aspartate aminotransferase (AST): NA, \>= 3 times upper limit of normal; total bilirubin: NA, \>=1.5 times upper limit of normal; calcium: \< 2.0, \> 2.75; gamma glutamyl transferase (GGT): \< 3.0, \> 9; potassium: \< 3.0, \> 5.5; magnesium: \< 0.5, \> 1.23.
Albumin,screening, High
Group
Value
95% CI
Placebo
0
GSK163090 1 mg
1
GSK163090 3 mg
1
Albumin,Day 14, High
Group
Value
95% CI
Placebo
1
GSK163090 1 mg
1
GSK163090 3 mg
0
ALT,Day 14, High
Group
Value
95% CI
Placebo
1
GSK163090 1 mg
0
GSK163090 3 mg
0
ALT,Day 42, High
Group
Value
95% CI
Placebo
0
GSK163090 1 mg
1
GSK163090 3 mg
0
AST,Day 42, High
Group
Value
95% CI
Placebo
0
GSK163090 1 mg
1
GSK163090 3 mg
0
Total bilirubin,screening, High
Group
Value
95% CI
Placebo
0
GSK163090 1 mg
1
GSK163090 3 mg
0
Total bilirubin,Day 7, High
Group
Value
95% CI
Placebo
0
GSK163090 1 mg
1
GSK163090 3 mg
0
Calcium,Day14, Low
Group
Value
95% CI
Placebo
1
GSK163090 1 mg
0
GSK163090 3 mg
1
Change From Baseline in Liver Chemistry -Alkaline Phosphatase (ALP), ALT, AST and GGTPrimary· Baseline (screening) up to Day 42
Clinical liver chemistry parameters of Alkaline Phosphatase , ALT, AST, GGT were assessed on screening, Day 7, Day 14, Day 28 and Day 42. Screening was defined as Baseline. Change from Baseline in liver chemistry was the difference between the value at time point analyzed and screening.
ALP,Day7
Group
Value
95% CI
Placebo
2.8
± 21.57
GSK163090 1 mg
-6.6
± 25.51
GSK163090 3 mg
-1.7
± 21.77
ALP,Day14
Group
Value
95% CI
Placebo
4.6
± 32.99
GSK163090 1 mg
2.5
± 9.79
GSK163090 3 mg
-5.4
± 26.57
ALP,Day28
Group
Value
95% CI
Placebo
-2.1
± 14.92
GSK163090 1 mg
-0.8
± 20.47
GSK163090 3 mg
0.8
± 13.12
ALP,Day42
Group
Value
95% CI
Placebo
-1.1
± 12.57
GSK163090 1 mg
8.7
± 45.92
GSK163090 3 mg
0.2
± 14.37
ALT,Day7
Group
Value
95% CI
Placebo
-1.0
± 14.85
GSK163090 1 mg
0.0
± 14.20
GSK163090 3 mg
-1.4
± 3.86
ALT,Day14
Group
Value
95% CI
Placebo
7.3
± 35.81
GSK163090 1 mg
-1.9
± 15.96
GSK163090 3 mg
-2.8
± 5.93
ALT,Day28
Group
Value
95% CI
Placebo
-2.8
± 5.97
GSK163090 1 mg
-2.9
± 13.49
GSK163090 3 mg
0.1
± 11.43
ALT,Day42
Group
Value
95% CI
Placebo
-2.7
± 10.88
GSK163090 1 mg
34.0
± 189.18
GSK163090 3 mg
-1.9
± 6.68
Change From Baseline in Liver Chemistry- Direct Bilirubin and Total BilirubinPrimary· Baseline (screening) up to Day 42
Liver chemistry parameters: Direct Bilirubin and Total Bilirubin were assessed on screening, Day 7, Day 14, Day 28 and Day 42. Screening was defined as Baseline. Change from Baseline in liver chemistry was the difference between the value at time point analyzed and screening.
Direct bilirubin,Day 7
Group
Value
95% CI
Placebo
0.59
± 1.745
GSK163090 1 mg
0.13
± 1.511
GSK163090 3 mg
0.38
± 1.142
Direct bilirubin,Day 14
Group
Value
95% CI
Placebo
0.61
± 1.490
GSK163090 1 mg
-0.14
± 1.369
GSK163090 3 mg
0.25
± 0.845
Direct bilirubin,Day 28
Group
Value
95% CI
Placebo
0.66
± 1.270
GSK163090 1 mg
-0.44
± 1.541
GSK163090 3 mg
0.06
± 1.227
Direct bilirubin,Day 42
Group
Value
95% CI
Placebo
0.31
± 1.508
GSK163090 1 mg
-0.08
± 1.517
GSK163090 3 mg
0.43
± 0.716
Total bilirubin,Day 7
Group
Value
95% CI
Placebo
1.36
± 4.465
GSK163090 1 mg
0.66
± 3.536
GSK163090 3 mg
1.05
± 3.771
Total bilirubin,Day 14
Group
Value
95% CI
Placebo
1.24
± 4.040
GSK163090 1 mg
-0.33
± 3.696
GSK163090 3 mg
0.59
± 2.211
Total bilirubin,Day 28
Group
Value
95% CI
Placebo
1.81
± 3.421
GSK163090 1 mg
-1.05
± 4.218
GSK163090 3 mg
0.33
± 3.251
Total bilirubin,Day 42
Group
Value
95% CI
Placebo
0.88
± 4.056
GSK163090 1 mg
-0.30
± 3.610
GSK163090 3 mg
1.28
± 2.704
Number of Participant of Urinanalysis Assessment Over PeriodPrimary· Screening (Day -10 to -2), Day 14 and Day 42
Urinalysis parameters included: Urine Occult Blood, Urine Ketones, Urine Ketones. data for number of participants with abnormal urinanalysis parameters was reported by dipstick method. dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. dipstick test gives results in a semi-quantitative manner, and results can be read as negative, Trace, 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Urine occult blood dipstick and urine general dipstick were semi quantitative results. Urine glucose and urine ketones dipstick results
screening ,urine Occult Blood,+
Group
Value
95% CI
Placebo
2
GSK163090 1 mg
2
GSK163090 3 mg
1
screening ,urine Occult Blood,++
Group
Value
95% CI
Placebo
4
GSK163090 1 mg
0
GSK163090 3 mg
2
screening ,urine Occult Blood,+++
Group
Value
95% CI
Placebo
1
GSK163090 1 mg
3
GSK163090 3 mg
0
screening,urine General,positive
Group
Value
95% CI
Placebo
10
GSK163090 1 mg
17
GSK163090 3 mg
9
screening,urine ketones,(1)
Group
Value
95% CI
Placebo
1
GSK163090 1 mg
0
GSK163090 3 mg
0
screening,urine ketones,(4)
Group
Value
95% CI
Placebo
0
GSK163090 1 mg
1
GSK163090 3 mg
0
screening,urine protein,(0.1)
Group
Value
95% CI
Placebo
1
GSK163090 1 mg
2
GSK163090 3 mg
5
screening,urine protein,(0.2)
Group
Value
95% CI
Placebo
2
GSK163090 1 mg
6
GSK163090 3 mg
3
Change From Baseline in Electrocardiogram (ECG) Values -PR Interval, QRS Duration, QT Interval, QTcB, QTcF, RR IntervalPrimary· Baseline (Day 1) and up to Day 42
Data for change from Baseline was reported for PR Interval, QRS Duration, QT Interval, QTcB, QTcF, and RR Interval. 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and QTcB ,QTcF, and RR intervals. Day -1 evening (PM) was the Baseline for participants with only Day -1 records. Day 1 PM Dose was the Baseline for participants with Day 1 records. Baseline was the mean of replicate assessments. Change from Baseline was the difference between the value at the time point analyzed and baseline va
PR Interval, Day -1,PM
Group
Value
95% CI
Placebo
149.9
± 20.06
GSK163090 1 mg
148.2
± 11.91
GSK163090 3 mg
158.7
± 16.05
PR Interval, Day 1PM dose,pre dose
Group
Value
95% CI
Placebo
156.4
± 22.70
GSK163090 1 mg
159.2
± 18.43
GSK163090 3 mg
163.6
± 30.35
PR Interval, Day 2AM dose,pre dose
Group
Value
95% CI
Placebo
-2.4
± 9.59
GSK163090 1 mg
-1.2
± 10.36
GSK163090 3 mg
-1.2
± 10.01
PR Interval, Day 2AM dose,3 h
Group
Value
95% CI
Placebo
-4.1
± 9.47
GSK163090 1 mg
-0.8
± 11.12
GSK163090 3 mg
-3.4
± 7.02
PR Interval, Day 2AM dose,6 h
Group
Value
95% CI
Placebo
-3.3
± 9.14
GSK163090 1 mg
-2.3
± 11.71
GSK163090 3 mg
-2.5
± 7.75
PR Interval, Day 7AM dose,pre dose
Group
Value
95% CI
Placebo
-1.5
± 12.93
GSK163090 1 mg
-2.6
± 10.99
GSK163090 3 mg
-1.6
± 9.68
PR Interval, Day 7AM dose,3 h
Group
Value
95% CI
Placebo
-4.8
± 11.71
GSK163090 1 mg
-1.0
± 11.44
GSK163090 3 mg
-0.5
± 8.58
PR Interval, Day 7AM dose,6 h
Group
Value
95% CI
Placebo
-1.8
± 13.56
GSK163090 1 mg
-3.6
± 11.56
GSK163090 3 mg
-1.8
± 9.94
Mean of Change From Baseline in Systolic and Diastolic Blood Pressure (BP)Primary· Baseline (Day 1) , Day 2, 3, 4, 5, 6, 7, 8, 14, 21, 28 and 42
Semi-supine systolic and diastolic blood pressure was assessed at the specified time points. Measurements were taken after the participant has been semi-supine for at least 5 minutes. BP was measured at least every hour until the values were within the normal range. Day 1 was Baseline and change from Baseline was difference between the value at the time point analyzed and baseline value.
Systolic BP, Day 1PM dose,pre dose
Group
Value
95% CI
Placebo
120.6
± 10.65
GSK163090 1 mg
120.3
± 9.31
GSK163090 3 mg
120.9
± 13.84
Systolic BP, Day 1PM dose,2 h
Group
Value
95% CI
Placebo
-0.8
± 3.55
GSK163090 1 mg
0.1
± 4.53
GSK163090 3 mg
1.5
± 8.16
Systolic BP ,Day 2AM dose,pre dose
Group
Value
95% CI
Placebo
-0.8
± 5.19
GSK163090 1 mg
1.2
± 5.98
GSK163090 3 mg
1.0
± 5.55
Systolic BP ,Day 2AM dose,3 h
Group
Value
95% CI
Placebo
-0.1
± 4.33
GSK163090 1 mg
1.0
± 5.51
GSK163090 3 mg
1.1
± 6.53
Systolic BP ,Day 2AM dose,6 h
Group
Value
95% CI
Placebo
-1.2
± 3.80
GSK163090 1 mg
0.2
± 4.34
GSK163090 3 mg
2.1
± 8.53
Systolic BP ,Day 2PM dose,1 h
Group
Value
95% CI
Placebo
-0.5
± 4.42
GSK163090 1 mg
0.3
± 4.80
GSK163090 3 mg
0.4
± 8.35
Systolic BP ,Day 3AM dose,pre dose
Group
Value
95% CI
Placebo
-1.6
± 9.23
GSK163090 1 mg
0.4
± 5.84
GSK163090 3 mg
-1.1
± 6.01
Systolic BP ,Day 3AM dose,3 h
Group
Value
95% CI
Placebo
-1.2
± 6.98
GSK163090 1 mg
0.5
± 7.10
GSK163090 3 mg
-0.8
± 5.32
Mean of Change From Baseline in Heart RatePrimary· Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 14, 21, 28 and 42
Heart rate is the speed of the heartbeat measured by the number of contractions of the heart per minute, (beats per minute). Heart rate was assessed at the specified time points. Measurements were taken after the participant has been semi-supine for at least 5 minutes. Day 1 was Baseline and change from Baseline was difference between the value at the time point analyzed and baseline value.
Heart rate, Day 1PM dose,pre dose
Group
Value
95% CI
Placebo
73.0
± 7.54
GSK163090 1 mg
73.3
± 10.67
GSK163090 3 mg
71.8
± 7.43
Heart rate, Day 1PM dose,2 h
Group
Value
95% CI
Placebo
1.4
± 6.83
GSK163090 1 mg
1.0
± 4.63
GSK163090 3 mg
1.1
± 5.12
Heart rate,Day 2AM dose,pre dose
Group
Value
95% CI
Placebo
-0.8
± 5.73
GSK163090 1 mg
0.4
± 8.27
GSK163090 3 mg
1.3
± 6.63
Heart rate,Day 2AM dose,3 h
Group
Value
95% CI
Placebo
0.8
± 5.19
GSK163090 1 mg
0.8
± 7.99
GSK163090 3 mg
2.5
± 6.47
Heart rate,Day 2AM dose,6 h
Group
Value
95% CI
Placebo
0.2
± 6.08
GSK163090 1 mg
1.9
± 7.27
GSK163090 3 mg
2.8
± 6.56
Heart rate,Day 2PM dose,1 h
Group
Value
95% CI
Placebo
0.6
± 7.02
GSK163090 1 mg
1.0
± 6.72
GSK163090 3 mg
2.4
± 7.28
Heart rate,Day 3AM dose,pre dose
Group
Value
95% CI
Placebo
-0.7
± 8.49
GSK163090 1 mg
1.2
± 6.49
GSK163090 3 mg
1.3
± 6.85
Heart rate,Day 3AM dose,3 h
Group
Value
95% CI
Placebo
0.1
± 8.26
GSK163090 1 mg
2.6
± 6.70
GSK163090 3 mg
2.0
± 5.38
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Day 52.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 19 March 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00896363.