Clinical trial NCT00420641: MDD POC Study GSK372475 Subjects Depressive Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder
Keywords: MDD
flexible-dose
Major Depressive Disorder
paroxetine
GSK372475
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Mean Change From Randomization at the End of the Treatment Phase in the MADRS Total Score
timeFrame: Week 0 (Randomization) and Week 10
measure: 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
measure: 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:
measure: Mean Change From Randomization in IDS- Self-Rated Version (SR) Total Score Over Week 10
timeFrame: Week 0 (Randomization) up to Week 10
measure: 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
measure: 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
measure: Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10
timeFrame: Week 0 (Randomization) up to Week 10
measure: Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10
timeFrame: Week 0 (Randomization) up to Week 10
measure: 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
measure: Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10
timeFrame: Week 0 (Randomization) up to Week 10
measure: Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10
timeFrame: Week 0 (Randomization) up to Week 10
measure: 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
measure: 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
measure: 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
measure: Mean Change From Randomization in the MADRS Total Score Over Week 8
timeFrame: Week 0 (Randomization) up to Week 8
measure: Mean Change From Randomization in IDS-CR Total Score Over Week 8
timeFrame: Week 0 (Randomization) up to Week 8
measure: 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
measure: Percentage of Responders and Remitters of MADRS Over Week 10
timeFrame: Up to Week 10
measure: Percentage of Responders and Remitters of IDS-CR Over Week 10
timeFrame: Up to Week 10
measure: Percentage of Responders and Remitters of HAMD-17 Over Week 10
timeFrame: Up to Week 10
measure: Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10
timeFrame: Up to Week 10
measure: Percentage of Participants Satisfied With Study Medication at Week 10
timeFrame: Week 10
measure: 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
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Miramichi
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Burlington
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Markham
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Providencia / Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Los Yoses, San José
country: Costa Rica
facility: GSK Investigational Site
state: San José
city: San José
country: Costa Rica
facility: GSK Investigational Site
city: Split
country: Croatia
facility: GSK Investigational Site
city: Zagreb
country: Croatia
facility: GSK Investigational Site
city: Angoulême
country: France
facility: GSK Investigational Site
city: Dole
country: France
facility: GSK Investigational Site
city: Elancourt
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Toulouse
country: France
facility: GSK Investigational Site
city: Toulouse
country: France
facility: GSK Investigational Site
city: Nuernberg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Huettenberg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Lucknow
country: India
facility: GSK Investigational Site
city: Mangalore
country: India
facility: GSK Investigational Site
city: Manipal,
country: India
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Pisa
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Chelmno
country: Poland
facility: GSK Investigational Site
city: Leszno
country: Poland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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;
citation: Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell JG, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. Efficacy, safety, and tolerability of a triple reuptake inhibitor GSK372475 in the treatment of patients with major depressive disorder: two randomized, placebo- and active-controlled clinical trials. J Psychopharmacol. 2012 May;26(5):653-62. doi: 10.1177/0269881111424931. Epub 2011 Nov 2.