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
Study complete
Study complete
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:
Enrollment:
396
Primary completion date:
2008-03-12
Observational study model:
Not applicable
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)
Showing 1 - 6 of 42 Results
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
Study complete
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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