MDD POC Study GSK372475 Subjects Depressive Disease

NCT00420641 | Completed Phase 2 Results

• 1 other identifier: SND 103288
• Study Type: interventional
• Target: 492
• Locations: 10 countries
• Sites: 33

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.

Conditions

Depressive Disorder

Keywords

MDD; flexible-dose; Major Depressive Disorder; paroxetine; GSK372475

Outcome Measures

Primary Outcomes (3)

• Mean Change From Randomization at the End of the Treatment Phase in the MADRS Total Score

  The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between MADRS total score at the time point being analyzed (Week 10) to Randomization.

  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

  The HAMD is a rating instrument for evaluating severity of symptoms of depression, was completed by the participant. The rating instrument used in this study was the 17-item version (HAM-D17). The Bech scale of the HAMD-17 is composed of 6 identified items out of the 17 items rated in HAMD-17 scale. Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4). The following symptoms were rated on a 5-point scale (0-4): depressed mood, feeling of guilt, work and interests, psychomotor retardation, and anxiety (psychic). The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general). Total score ranged from 0 to 22, with 0 indicating absence of symptoms and a higher score indicating greater severity of symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between Bech total score at the time point being analyzed (Week 10) to Randomization.

  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

  The IDS-CR is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. In order to calculate the total score of IDS-CR, the following procedures were used: either item 11 or 12 were scored; either item 13 or 14 were scored; if both items 11 and 12 (or 13 and 14) were scored, the highest of the items was scored. The total score was obtained by adding the scores of 28 items of the 30 items. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between IDS-CR total score at the time point being analyzed (Week 10) to Randomization.

  Week 0 (Randomization) and Week 10

Secondary Outcomes (20)

• Mean Change From Randomization in IDS- Self-Rated Version (SR) Total Score Over Week 10

  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

  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

  Week 0 (Randomization) up to Week 10

• Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10

  Week 0 (Randomization) up to Week 10

• Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10

  Week 0 (Randomization) up to Week 10

Study Arms (3)

GSK372475 Arm

EXPERIMENTAL

GSK372475 1.0- 1.5 mg/day

Drug: GSK372475

Paroxetine Arm

EXPERIMENTAL

Paroxetine 20-30 mg/day

Drug: Paroxetine

Placebo

OTHER

Placebo to Match

Other: Placebo

Interventions

GSK372475 DRUG

GSK372475 1.0-1.5 mg/day

GSK372475 Arm

Paroxetine DRUG

Paroxetine 20-30 mg/day

Paroxetine Arm

Placebo OTHER

Placebo to Match

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (33)

GSK Investigational Site

Plovdiv, 4000, Bulgaria

Location

GSK Investigational Site

Sofia, 1000, Bulgaria

Location

GSK Investigational Site

Miramichi, New Brunswick, E1V 3G5, Canada

Location

GSK Investigational Site

Burlington, Ontario, L7R 4E2, Canada

Location

GSK Investigational Site

Markham, Ontario, L6B 1A1, Canada

Location

GSK Investigational Site

Mississauga, Ontario, L5M 4N4, Canada

Location

GSK Investigational Site

Providencia / Santiago, Región Metro de Santiago, 7500710, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7510186, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7580208, Chile

Location

GSK Investigational Site

Los Yoses, San José, Provincia de San José, Costa Rica

Location

GSK Investigational Site

San José, Costa Rica

Location

GSK Investigational Site

Split, 21000, Croatia

Location

GSK Investigational Site

Zagreb, 10000, Croatia

Location

GSK Investigational Site

Angoulême, 16000, France

Location

GSK Investigational Site

Dole, 39100, France

Location

GSK Investigational Site

Élancourt, 78990, France

Location

GSK Investigational Site

Paris, 75014, France

Location

GSK Investigational Site

Toulouse, 31000, France

Location

GSK Investigational Site

Toulouse, 31200, France

Location

GSK Investigational Site

Nuremberg, Bavaria, 90402, Germany

Location

GSK Investigational Site

Hüttenberg, Hesse, 35625, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01097, Germany

Location

GSK Investigational Site

Berlin, 10629, Germany

Location

GSK Investigational Site

Bangalore, 560029, India

Location

GSK Investigational Site

Bangalore, 560034, India

Location

GSK Investigational Site

Lucknow, 226003, India

Location

GSK Investigational Site

Mangalore, 575018, India

Location

GSK Investigational Site

Manipal, 576 104, India

Location

GSK Investigational Site

Milan, Lombardy, 20127, Italy

Location

GSK Investigational Site

Pisa, Tuscany, 56126, Italy

Location

GSK Investigational Site

Bialystok, 15-879, Poland

Location

GSK Investigational Site

Chełmno, 86-200, Poland

Location

GSK Investigational Site

Leszno, 64-100, Poland

Location

Related Publications (2)

• 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;

  BACKGROUND

• 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.

  PMID: 22048884 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Depressive Disorder, Major

Interventions

GSK372475; Paroxetine

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2007
• First Posted: January 11, 2007
• Study Start: December 19, 2006
• Primary Completion: June 1, 2008
• Study Completion: October 15, 2008
• Last Updated: February 5, 2018
• Results First Posted: February 5, 2018

Record last verified: 2014-10

Locations

CA (4); IN (5); CR (2); DE (4); BU (2); PL (3); CO (2); CL (3); FR (6); IT (2)