Back to resultsSafety and Efficacy Study in Patients With Major Depressive Disorder
Primary Purpose
Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
GSK163090 1 mg
GSK163090 Placebo
GSK163090 3 mg
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder focused on measuring anti-depressant, Severe Depression, Efficacy, Major Depressive Disorder, Major Depressive Episode
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
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
Parallel Group - High Dose Arm, Low Dose Arm
Parallel Group
Outcomes
Primary Outcome Measures
Change From Baseline in the Hamilton Depression Rating Scale (HAMD17), on Day 14 and 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 lowest possible score was 0, which represents an absence of depression. Baseline was defined as the assessment done on Day 1 (pre-dose). Change from baseline in total Score was the difference between HAMD total score at the time point being analyzed to Day 1.
Change From Baseline in Bech Melancholia Subscale (BECH 6) Scale, on Day 14 and 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 from baseline was the difference between BECH 6 scale at the time point being analyzed to randomization.
Change From Baseline in Quick Inventory of Depressive Symtomatology - Self Rated (QIDS-SR) Scale, on Day 14 and 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, which represents an absence of depression. Baseline was defined as the assessment done on Day 1. Change from Randomization in total score was the difference between QIDS total score at the time point being analyzed to randomization.
Number of Participants With Suicidal Behavior and Suicidal Ideation Subscales of the Columbia Suicide Severity Rating Scale (C-SSRS)
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 to be dead-1, non-specific active suicidal thoughts-2, active suicidal ideation with associated thoughts of methods without intent-3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan-4, active suicidal ideation with plan and intent-5. The score ranges from 0-5, where 0 was absence of suicidal ideation and 5 being the most severe form of suicidal ideation.
Number of Participants With Abnormal Hematology Values of Clinical Concern Range (CCR).
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
Number of Participants With Abnormal Chemistry Values of CCR
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.
Change From Baseline in Liver Chemistry -Alkaline Phosphatase (ALP), ALT, AST and GGT
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.
Change From Baseline in Liver Chemistry- Direct Bilirubin and Total Bilirubin
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.
Number of Participant of Urinanalysis Assessment Over Period
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 were in milimole per liter, urine protein dipstick results were in gram per liter.
Change From Baseline in Electrocardiogram (ECG) Values -PR Interval, QRS Duration, QT Interval, QTcB, QTcF, RR Interval
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 value.
Mean of Change From Baseline in Systolic and Diastolic Blood Pressure (BP)
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.
Mean of Change From Baseline in Heart Rate
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.
Number of Participants With All Adverse Events (AEs), and Serious Adverse Events (SAEs)
Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Secondary Outcome Measures
Mean Last Observed Quantifiable Concentration (Ct) of GSK163090 Over the Period
Ctrough is defined as trough plasma concentration (measured concentration at the end of a dosing interval at steady state [taken directly before next administration]). Concentration was reported at specified time points.
Area Under Concentration-time Curve (AUC) at Steady State
PK samples were supposed to be collected to estimate individual specific parameters like AUC however data for this outcome was not collected.
Average Concentration (Cave) at Steady State
PK samples were supposed to be collected to estimate individual specific parameters like Cave however data for this outcome was not collected.
Preliminary Pharmacokinetic/ Pharmacodynamic (PK/PD)Relationships for GSK163090 in Participants With MDD.
PK/PD relationships for GSK163090 in participants with MDD data was not collected.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00896363
Brief Title
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 23, 2009 (Actual)
Primary Completion Date
February 9, 2010 (Actual)
Study Completion Date
February 9, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
anti-depressant, Severe Depression, Efficacy, Major Depressive Disorder, Major Depressive Episode
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Active Comparator
Arm Description
Parallel Group - High Dose Arm, Low Dose Arm
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Parallel Group
Intervention Type
Drug
Intervention Name(s)
GSK163090 1 mg
Intervention Description
Developed for the treatment of Major Depressive Disorder
Intervention Type
Drug
Intervention Name(s)
GSK163090 Placebo
Intervention Description
Developed for the treatment of Major Depressive Disorder
Intervention Type
Drug
Intervention Name(s)
GSK163090 3 mg
Intervention Description
Developed for the treatment of Major Depressive Disorder
Primary Outcome Measure Information:
Title
Change From Baseline in the Hamilton Depression Rating Scale (HAMD17), on Day 14 and 42
Description
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 lowest possible score was 0, which represents an absence of depression. Baseline was defined as the assessment done on Day 1 (pre-dose). Change from baseline in total Score was the difference between HAMD total score at the time point being analyzed to Day 1.
Time Frame
Baseline (Day 1, pre-dose), Day 14 and Day 42
Title
Change From Baseline in Bech Melancholia Subscale (BECH 6) Scale, on Day 14 and 42
Description
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 from baseline was the difference between BECH 6 scale at the time point being analyzed to randomization.
Time Frame
Baseline (Day 1, pre-dose), Day 14 and Day 42
Title
Change From Baseline in Quick Inventory of Depressive Symtomatology - Self Rated (QIDS-SR) Scale, on Day 14 and 42
Description
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, which represents an absence of depression. Baseline was defined as the assessment done on Day 1. Change from Randomization in total score was the difference between QIDS total score at the time point being analyzed to randomization.
Time Frame
Baseline (Day 1, pre-dose), Day 14 and Day 42
Title
Number of Participants With Suicidal Behavior and Suicidal Ideation Subscales of the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
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 to be dead-1, non-specific active suicidal thoughts-2, active suicidal ideation with associated thoughts of methods without intent-3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan-4, active suicidal ideation with plan and intent-5. The score ranges from 0-5, where 0 was absence of suicidal ideation and 5 being the most severe form of suicidal ideation.
Time Frame
Up to Day 52
Title
Number of Participants With Abnormal Hematology Values of Clinical Concern Range (CCR).
Description
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
Time Frame
Up to Day 42
Title
Number of Participants With Abnormal Chemistry Values of CCR
Description
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.
Time Frame
Up to Day 42
Title
Change From Baseline in Liver Chemistry -Alkaline Phosphatase (ALP), ALT, AST and GGT
Description
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.
Time Frame
Baseline (screening) up to Day 42
Title
Change From Baseline in Liver Chemistry- Direct Bilirubin and Total Bilirubin
Description
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.
Time Frame
Baseline (screening) up to Day 42
Title
Number of Participant of Urinanalysis Assessment Over Period
Description
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 were in milimole per liter, urine protein dipstick results were in gram per liter.
Time Frame
Screening (Day -10 to -2), Day 14 and Day 42
Title
Change From Baseline in Electrocardiogram (ECG) Values -PR Interval, QRS Duration, QT Interval, QTcB, QTcF, RR Interval
Description
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 value.
Time Frame
Baseline (Day 1) and up to Day 42
Title
Mean of Change From Baseline in Systolic and Diastolic Blood Pressure (BP)
Description
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.
Time Frame
Baseline (Day 1) , Day 2, 3, 4, 5, 6, 7, 8, 14, 21, 28 and 42
Title
Mean of Change From Baseline in Heart Rate
Description
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.
Time Frame
Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 14, 21, 28 and 42
Title
Number of Participants With All Adverse Events (AEs), and Serious Adverse Events (SAEs)
Description
Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Time Frame
Up to Day 52
Secondary Outcome Measure Information:
Title
Mean Last Observed Quantifiable Concentration (Ct) of GSK163090 Over the Period
Description
Ctrough is defined as trough plasma concentration (measured concentration at the end of a dosing interval at steady state [taken directly before next administration]). Concentration was reported at specified time points.
Time Frame
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)
Title
Area Under Concentration-time Curve (AUC) at Steady State
Description
PK samples were supposed to be collected to estimate individual specific parameters like AUC however data for this outcome was not collected.
Time Frame
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)
Title
Average Concentration (Cave) at Steady State
Description
PK samples were supposed to be collected to estimate individual specific parameters like Cave however data for this outcome was not collected.
Time Frame
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)
Title
Preliminary Pharmacokinetic/ Pharmacodynamic (PK/PD)Relationships for GSK163090 in Participants With MDD.
Description
PK/PD relationships for GSK163090 in participants with MDD data was not collected.
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620030
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Kemerovo
ZIP/Postal Code
650036
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Lipetsk Region
ZIP/Postal Code
399083
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Nizhny Novgorod
ZIP/Postal Code
603107
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saint Petersburg
ZIP/Postal Code
190005
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saint Petersburg
ZIP/Postal Code
191180
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saint-Petersburg
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saratov
ZIP/Postal Code
410060
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Smolensk
ZIP/Postal Code
214 019
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St.Petersburg
ZIP/Postal Code
193167
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Tomsk
ZIP/Postal Code
634014
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109035
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109035
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109035
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109035
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109035
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109035
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109035
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Safety and Efficacy Study in Patients With Major Depressive Disorder
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