Last updated: 11/04/2018 12:28:42
A Study Of New Medicine (GSK 372475) For The Treatment Of Depression
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/day to 2.0 mg/day) or Extended Release Venlafaxine XR (150 mg/day to 225 mg/day) Compared to Placebo in adult s
Trial description: To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects with Major Depressive Disorder (MDD)
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from randomization (Baseline) at the end of the Treatment Phase (Week 10) in the 6-item Bech scale (Items 1, 2, 7, 8, 10, 13) extracted from the Hamilton Depression (HAMD-17)
Timeframe: Baseline (Day 0) and Week 10
Change From Randomization at End of the Treatment Phase (Week 10) in the Inventory of Depressive Symptomatology–Clinician Rated (IDS-CR) total score
Timeframe: Baseline (Day 0) and Week 10
Secondary outcomes:
Change from randomization at Weeks 1, 2, 4, 6 and 8 in the IDS-CR total score
Timeframe: Baseline (Day 0) and up to Week 8
Change from randomization at Weeks 1, 4 and 10 in the IDS – Self-rated version (IDS-SR) total score.
Timeframe: Baseline (Day 0) and Weeks 1, 4 and 10
Change from randomization at Weeks 1, 2, 4, 6, 8 and 10 in the 16-item Quick Inventory of Depressive Symptomatology – CR (QIDS-CR 16) total score.
Timeframe: Baseline (Day 0) and up to Week 10
Change from randomization at Weeks 1, 4 and 10 in the 16-item QIDS-SR 16 total score
Timeframe: Baseline (Day 0) and Weeks 1, 4, 10
Change from randomization at Weeks 1, 2, 4, 6, 8, and 10 in item 5 (feeling sad) of the IDS-CR
Timeframe: Baseline (Day 0) and up to Week 10
Change from randomization to End of treatment phase (Week 10) in the HAMD-17 total score
Timeframe: Baseline (Day 0) and Week 10
Change from randomization at Weeks 1, 2, 4, 6 and 8 in the 6-item Bech scale extracted from the HAMD-17.
Timeframe: Baseline (Day 0) and up to Week 8
Change from randomization at Weeks 1, 2, 4, 6, 8, and 10 in item 1 (depressed mood) of the HAMD-17
Timeframe: Baseline (Day 0) and up to Week 10
Number of participants who were responders on IDS-CR scale at Weeks 1, 2, 4, 6, 8, and 10
Timeframe: Upto Week 10
Number of participants who were responders on HAMD-17 scale at Weeks 1, 2, 4, 6, 8
Timeframe: Upto Week 8
Number of participants who were remitters on IDS-CR scale at Weeks 1, 2, 4, 6, 8, and 10
Timeframe: Up to Week 10
Number of participants who were remitters on HAMD-17 scale at Weeks 1, 2, 4, 6, 8 and 10
Timeframe: Up to Week 10
Change from randomization to End of treatment phase (Week 10) in Analysis of 5 item IDS-subscale consisting of item 19, 20, 21, 22 and 30 (Pleasure, Interest, Energy)
Timeframe: Baseline (Day 0) and Week 10
Change from randomization at Weeks 1, 2, 3, 4, 5, 6 and 8 in Analysis of 5 item IDS-subscale consisting of item 19, 20 , 21, 22 and 30 (PIE)
Timeframe: Baseline (Day 0) and Up to Week 8
Change from randomization in the Clinical Global Impression - Severity of Illness (CGI-S) at Weeks 1, 2, 4, 6, 8, and 10
Timeframe: Baseline (Day 0) and Up to Week 10
Number of participants who were responders on CGI-I scale at Weeks 1, 2, 4, 6, 8, and 10.
Timeframe: Upto Week 10
Participant Satisfaction with Study Medication Question score at Week 10
Timeframe: Week 10
Change from randomization at Weeks 1, 4 and 10 in the Motivation and Energy Inventory (MEI) 18-Item Short Form (SF) total score
Timeframe: Baseline (Randomization, Day 0) and Weeks 1, 4, 10
Change from randomization at Weeks 4 and 10 in the Changes in Sexual Functioning Questionnaire (CSFQ) 14-item SF.
Timeframe: Baseline (Day 0) and Weeks 4, 10
Interventions:
Drug: GSK372475
Drug: venlafaxine
Drug: placebo
Enrollment:
396
Observational study model:
Not applicable
Primary completion date:
2008-03-12
Time perspective:
Not applicable
Clinical publications:
Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell J, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. Results of Two Double-Blind, Placebo- and Active-Controlled Studies of GSK372475, a Triple Monoamine Reuptake Inhibitor, in the Treatment of Major Depressive Disorder. [J Psychopharmacol EPublication ahead of print. DOI 10.1177/0269881111424931]. 2011;
Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell J, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. with major depressive disorder: two randomized, placebo- and active-controlled clinical trials Efficacy, safety, and tolerability of a triple reuptake inhibitor GSK372475 in the treatment of patients. J Psychopharmacol. 2012;26(5):653-662.
Medical condition
Depressive Disorder
Product
GSK372475
Collaborators
Not applicable
Study date(s)
April 2007 to December 2008
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
No
- Major depressive episode (MDE) associated with Major Depressive Disorder (DSM-IV-TR criteria)
- Duration of current episode is at least 12 weeks duration and less than 2 years
- Current diagnosis of Panic Disorder, or symptoms of generalized anxiety or panic attacks that could interfere with their ability to complete the trial
- Symptoms of MDE better accounted for by another diagnosis
Inclusion and exclusion criteria
Inclusion criteria:
- Major depressive episode (MDE) associated with Major Depressive Disorder (DSM-IV-TR criteria)
- Duration of current episode is at least 12 weeks duration and less than 2 years
- Symptoms of decreased energy, pleasure, and interest
- Female subjects who agree to use acceptable methods of birth control throughout the study
Exclusion criteria:
- Current diagnosis of Panic Disorder, or symptoms of generalized anxiety or panic attacks that could interfere with their ability to complete the trial
- Symptoms of MDE better accounted for by another diagnosis
- Diagnosis of Bipolar, schizophrenia, other psychotic disorder(s), borderline or antisocial personality disorder, or dementia.
- Started psychotherapy within 3 months prior to the Screening
- Received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening -Received psychoactive drugs within 4 weeks of randomization
- Positive urine drug screen or positive blood alcohol
- Suicidal risk or has had any previous suicide attempt, a family history of suicide attempt
- Positive pregnancy test
- History of seizure disorder, myocardial infarction (< 1yr), or unstable medical condition
- Failed to respond to an adequate course of pharmacotherapy of at least 2 different antidepressants
Trial location(s)
Location
GSK Investigational Site
Montreal, Québec, Canada, H2T 2N6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Status
Study Complete
Location
GSK Investigational Site
Westerstede, Niedersachsen, Germany, 26655
Status
Study Complete
Location
GSK Investigational Site
Kelowna, British Columbia, Canada, V1Y 2H4
Status
Study Complete
Location
GSK Investigational Site
Auchenflower, Queensland, Australia, 4066
Status
Study Complete
Location
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19053
Status
Study Complete
Location
GSK Investigational Site
Heidelberg West, Victoria, Australia, 3081
Status
Study Complete
Location
GSK Investigational Site
Observatory ,Cape Town, South Africa, 7925
Status
Study Complete
Study documents
Scientific result summary
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
2008-03-12
Actual study completion date
2008-03-12
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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