Last updated: 11/04/2018 09:41:06
Study Of GW679769 In Major Depressive Disorder
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Evaluating the Efficacy and Safety of GW679769 in Subjects with Major Depressive Disorder.
Trial description: This is a placebo-controlled, fixed dose study that will evaluate the efficacy and safety of GW679769 in subjects with major depressive disorder.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Change from Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) total score at Week 8, Last Observation Carried Forward (LOCF)
Timeframe: Baseline (Visit 2) and Week 8
Secondary outcomes:
Number of participants with a greater than or equal to 50 percent reduction from Baseline in HAM-D total score
Timeframe: Up to Week 8
Number of participants with HAM-D total score less than or equal to 7
Timeframe: Up to Week 8
Number of participants with Clinical Global Impression- Global Improvement (CGI-I) score
Timeframe: Up to Week 8
Change from Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) score
Timeframe: Baseline (Visit 2) up to Week 8
Change from Baseline in the HAM-D item 1 (depressed mood) score
Timeframe: Baseline (Visit 2) to Week 8
Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score
Timeframe: Baseline (Visit 2) to Week 8
Change from Baseline on the HAM-A psychic anxiety subscale score
Timeframe: Baseline (Visit 2) to Week 8
Change from Baseline on the HAM-A somatic anxiety subscale score
Timeframe: Baseline (Visit 2) to Week 8
Change from Baseline in the HAM-D anxiety factor score over 8 Weeks
Timeframe: Baseline (Visit 2) to Week 8
Change from Baseline in the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR 16)
Timeframe: Baseline (Visit 2) to Week 8
Change from Baseline in item 5 (feeling sad) of the QIDS-SR 16
Timeframe: Baseline (Visit 2) to Week 8
Change from Baseline in the Sheehan Disability Scale (SDS) total score at Week 4 and Week 8
Timeframe: Baseline (Visit 2), Week 4 and Week 8
Change from Baseline in the SDS Work item score
Timeframe: Baseline (Visit 2) to Week 8
Change from Baseline in the SDS Family item score
Timeframe: Baseline (Visit 2) to Week 8
Change from Baseline in the SDS Social item score
Timeframe: Baseline (Visit 2) to Week 8
Change from Baseline on the Medical Outcomes Study (MOS) 12-item Sleep Module at Weeks 1, 2, 4 and 8
Timeframe: Baseline (Visit 2) to Week 8
Change on the Leeds Sleep Evaluation Questionnaire (LSEQ) “Getting to Sleep (GTS)” subscale score at Week 8
Timeframe: Week 8
Change on the LSEQ "QOS” subscale score at Week 8
Timeframe: Week 8
Change on the LSEQ “AFS” subscale score at Week 8
Timeframe: Week 8
Change on the LSEQ “BFW” subscale score at Week 8
Timeframe: Week 8
Number of participants withdrawing due to an adverse event (AE)
Timeframe: Up to 28-Day Follow-up visit
Number of participants who reported at least one serious adverse event (SAE)
Timeframe: Up to 28-Day Follow-up visit
Number of participants with clinical chemistry data outside the reference range of potential clinical concern (PCC) at any time on-treatment
Timeframe: Up to Week 8
Number of participants with hematology data outside the reference range of PCC at any time on-treatment
Timeframe: Up to Week 8
Number of participants with positive results (findings) during urinalysis dipstick test
Timeframe: Up to Week 8
Number of participants with on-treatment ALT or AST>= 2 or 3 Times upper level of normal (ULN), ALT>=3 Times ULN, Total Bilirubin >=1.5 times ULN, Creatine Kinase >=5 or 8 times ULN
Timeframe: Up to Week 8
Number of participants with on-treatment troponin I Increase > 1 Times ULN or >= 2 Times their Baseline Value and Serum Pepsinogen I < Lower Level Reference Range (LLRR)
Timeframe: Up to Week 8
Number of participants with change from Baseline in electrocardiogram (ECG) of Potential clinical importance (PCI) at any time on-treatment
Timeframe: Baseline (Visit 2) to Week 8
Number of participants with change from Baseline in Systolic blood pressure (SBP), diastolic blood pressure (DBP), HR, and body weight of PCI at any time on treatment
Timeframe: Up to Week 8
Area under the plasma drug concentration curve at steady state over dosing time (AUC(0-T))
Timeframe: Up to Week 8
PK and PK/Pharmacodynamic (PD) assessments
Timeframe: Up to Week 8
Maximum concentration (Cmax) and Plasma trough concentration (Ctrough)
Timeframe: Up to Week 8
Interventions:
Drug: GW679769
Enrollment:
356
Observational study model:
Not applicable
Primary completion date:
2006-12-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Major Depressive Disorder (MDD)
Product
casopitant, paroxetine
Collaborators
Not applicable
Study date(s)
October 2004 to September 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
Yes
- Subjects must have the ability to comprehend the key components of the consent form.
- Subject must have met DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria for current MDE (major depressive episode) for at least 8 weeks prior to the Screening Visit.
- Subjects whose symptoms of the MDE are better accounted for by another diagnosis.
- Subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects must have the ability to comprehend the key components of the consent form.
- Subject must have met DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria for current MDE (major depressive episode) for at least 8 weeks prior to the Screening Visit.
- If female, subjects must be practicing an acceptable method of birth control.
- Subjects must have rating scores as outlined.
Exclusion criteria:
- Subjects whose symptoms of the MDE are better accounted for by another diagnosis.
- Subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder.
- Subjects have a positive urine test for illicit drug use and/or a history of substance abuse or alcohol dependence within the past 12 months.
- Subjects with an unstable medical disorder.
- If female, pregnant or lactating.
- Subjects who have received ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation) within the 6 months preceding screening or who have ever been homicidal.
Trial location(s)
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32806
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, New York, United States, 11235
Status
Study Complete
Location
GSK Investigational Site
Winter Park, Florida, United States, 32789
Status
Study Complete
Location
GSK Investigational Site
Lake Jackson, Texas, United States, 77566
Status
Study Complete
Location
GSK Investigational Site
Oakbrook Terrace, Illinois, United States, 60181
Status
Study Complete
Location
GSK Investigational Site
Rockville, Maryland, United States, 20852
Status
Study Complete
Location
GSK Investigational Site
Bellevue, Washington, United States, 98004
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72223
Status
Study Complete
Location
GSK Investigational Site
Farmington Hills, Michigan, United States, 48336
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97209
Status
Study Complete
Location
GSK Investigational Site
St. Charles, Missouri, United States, 63301
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30060
Status
Study Complete
Location
GSK Investigational Site
Clementon, New Jersey, United States, 08021
Status
Study Complete
Location
GSK Investigational Site
Miramichi, New Brunswick, Canada, E1V 3G5
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10024
Status
Study Complete
Location
GSK Investigational Site
Beverly Hills, California, United States, 90210
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33301
Status
Study Complete
Location
GSK Investigational Site
North Miami, Florida, United States, 33161
Status
Study Complete
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71104
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38119
Status
Study Complete
Location
GSK Investigational Site
Brown Deer, Wisconsin, United States, 53223
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
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
2006-12-09
Actual study completion date
2006-12-09
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
Additional information
Not applicable
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