Last updated: 11/04/2018 12:28:52
MDD POC Study GSK372475 Subjects Depressive Disease
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, Paralleled-Group, Flexible-Dose study Evaluating the Efficacy, Safety and Tolerability of GSK372475 or Paroxetine Compared to Placebo in Adult Subjects Diagnosed with Major Depressive Disorder
Trial description: To evaluate the efficacy, safety and tolerability of GSK372475 compared with placebo in the treatment of outpatients subjects with major depressive disorder to exhibit decreased pleasure, interest and energy.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from Randomization at the end of the Treatment Phase in the MADRS total score
Timeframe: Week 0 (Randomization) and Week 10
Change from Randomization at the end of the Treatment Phase (Week 10) in Bech scale (6-item of 17-item Hamilton depression rating [HAMD-17] scale) score
Timeframe: Week 0 (Randomization) and Week 10
Mean change from Randomization at the end of the Treatment Phase (Week 10) in Inventory of Depressive Symptomatology–Clinician Rated (IDS-CR) total score
Timeframe: Week 0 (Randomization) and Week 10
Secondary outcomes:
Mean change from Randomization in IDS– Self-Rated version (SR) total score over Week 10
Timeframe: Week 0 (Randomization) up to Week 10
Mean change from Randomization in the 16-item Quick Inventory of Depressive Symptomatology–Clinician-rated version (QIDS-CR16) total score over Week 10
Timeframe: Week 0 (Randomization) up to Week 10
Mean change from Randomization in the 16-item Quick Inventory of Depressive Symptomatology–Self-rated version (QIDS-SR16) total score over Week 10
Timeframe: Week 0 (Randomization) up to Week 10
Mean change from Randomization in the MADRS Item 2 score (Reported Sadness) over Week 10
Timeframe: Week 0 (Randomization) up to Week 10
Mean change from Randomization in the IDS-CR scale Item 5 (Feeling Sad) over Week 10
Timeframe: Week 0 (Randomization) up to Week 10
Mean change from Randomization at the end of the Treatment Phase (Week 10) in the HAMD-17 total score
Timeframe: Week 0 (Randomization) and Week 10
Mean change from Randomization in the HAMD-17 scale Item 1 (Depressed Mood) over Week 10
Timeframe: Week 0 (Randomization) up to Week 10
Mean change from Randomization in IDS-CR and IDS-SR 5 Item subscale over Week 10
Timeframe: Week 0 (Randomization) up to Week 10
Mean change from Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) scale over Week 10
Timeframe: Week 0 (Randomization) up to Week 10
Mean change from Randomization in the Motivation and Energy Inventory (MEI) 18-Item Short Form (SF) total score over Week 10
Timeframe: Week 0 (Randomization) up to Week 10
Mean change from Randomization in the Changes in Sexual Functioning Questionnaire 14-item Short Form (CSFQ-14SF) over Week 10
Timeframe: Week 0 (Randomization) up to Week 10
Mean change from Randomization in the MADRS total score over Week 8
Timeframe: Week 0 (Randomization) up to Week 8
Mean Change from Randomization in IDS-CR total score over Week 8
Timeframe: Week 0 (Randomization) up to Week 8
Mean change from Randomization in the in Bech scale (6-item of HAMD-17 scale) score over Week 8
Timeframe: Week 0 (Randomization) up to Week 8
Percentage of responders and remitters of MADRS over Week 10
Timeframe: Up to Week 10
Percentage of responders and remitters of IDS-CR over Week 10
Timeframe: Up to Week 10
Percentage of responders and remitters of HAMD-17 over Week 10
Timeframe: Up to Week 10
Percentage of participants with Clinical Global Impression - Global Improvement (CGI-I) over Week 10
Timeframe: Up to Week 10
Percentage of participants satisfied with study medication at Week 10
Timeframe: Week 10
Number of participants with most severe suicidal behaviour and ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) subscales of the Columbia Suicide Severity Rating Scale (CSSRS) over Week 10
Timeframe: Up to Week 10
Interventions:
Drug: GSK372475
Drug: Paroxetine
Other: Placebo
Enrollment:
492
Observational study model:
Not applicable
Primary completion date:
2008-15-10
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, paroxetine
Collaborators
Not applicable
Study date(s)
December 2006 to October 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 panic disorder / attacks, generalised anxiety, borderline or antisocial personality disorder, dementia, anorexia nervosa / bulimia (within 6 months of screening), bipolar disorder, schizophrenia or any other psychotic disorder(s).
- 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
Miramichi, New Brunswick, Canada, E1V 3G5
Status
Study Complete
Location
GSK Investigational Site
Providencia / Santiago, Región Metro De Santiago, Chile, 7500710
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7580208
Status
Study Complete
Location
GSK Investigational Site
Los Yoses, San José, San José, Costa Rica
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
2008-15-10
Actual study completion date
2008-15-10
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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