Phase 2
N=504
MDD POC Study GSK372475 Subjects Depressive Disease
Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00420641 ↗Enrolled (actual)
504
Serious AEs
2.6%
Results posted
Feb 2018
Primary outcome: Primary: Mean Change From Randomization at the End of the Treatment Phase in the MADRS Total Score — -16.9; -19.0; -20.5 Score on scale — p=0.485
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GSK372475 (Drug); Paroxetine (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Randomization at the End of the Treatment Phase in the MADRS Total Score |
-16.9; -19.0; -20.5 | 0.485 |
| PRIMARY 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 |
-6.2; -7.2; -7.9 | 0.252 |
| PRIMARY Mean Change From Randomization at the End of the Treatment Phase (Week 10) in Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Total Score |
-22.3; -25.1; -26.8 | 0.279 |
| SECONDARY Mean Change From Randomization in IDS- Self-Rated Version (SR) Total Score Over Week 10 |
-7.6; -7.6; -8.6; -16.8; -15.5; -19.1 | 0.287 |
| SECONDARY Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 |
-1.5; -1.8; -1.8; -3.3; -3.6; -3.4 | 0.352 |
| SECONDARY Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Self-rated Version (QIDS-SR16) Total Score Over Week 10 |
-2.7; -3.1; -2.9; -6.4; -5.7; -6.9 | 0.168 |
| SECONDARY Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 |
-0.4; -0.5; -0.4; -0.8; -0.9; -0.9 | 0.257 |
| SECONDARY Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 |
-0.2; -0.3; -0.3; -0.5; -0.5; -0.6 | 0.096 |
| SECONDARY Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score |
-1.9; -1.9; -2.3; -4.3; -4.2; -4.8 | 0.576 |
| SECONDARY Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 |
-0.3; -0.4; -0.3; -0.6; -0.7; -0.7 | 0.209 |
| SECONDARY Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 |
-0.8; -1.2; -0.8; -1.6; -2.5; -2.0 | 0.175 |
| SECONDARY Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 |
-0.2; -0.3; -0.2; -0.5; -0.5; -0.6 | 0.208 |
| SECONDARY Mean Change From Randomization in the Motivation and Energy Inventory (MEI) 18-Item Short Form (SF) Total Score Over Week 10 |
3.8; 5.7; 4.9; 16.1; 15.4; 18.4 | 0.516 |
| SECONDARY Mean Change From Randomization in the Changes in Sexual Functioning Questionnaire 14-item Short Form (CSFQ-14SF) Over Week 10 |
2.4; 3.1; 1.3; 4.6; 6.1; 4.4 | 0.126 |
| SECONDARY Mean Change From Randomization in the MADRS Total Score Over Week 8 |
-2.9; -2.8; -2.8; -6.3; -5.7; -6.6 | — |
| SECONDARY Mean Change From Randomization in IDS-CR Total Score Over Week 8 |
-4.4; -4.9; -5.1; -8.8; -9.7; -9.8 | — |
| SECONDARY Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 |
-0.8; -1.0; -1.2; -2.0; -2.2; -2.6 | — |
| SECONDARY Percentage of Responders and Remitters of MADRS Over Week 10 |
3; 3; 4; 8; 11; 13 | 0.5061 |
| SECONDARY Percentage of Responders and Remitters of IDS-CR Over Week 10 |
4; 3; 5; 8; 11; 14 | 0.5072 |
| SECONDARY Percentage of Responders and Remitters of HAMD-17 Over Week 10 |
3; 2; 4; 8; 10; 14 | 0.5057 |
| SECONDARY Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 |
3; 4; 5; 12; 17; 20 | 0.6928 |
| SECONDARY Percentage of Participants Satisfied With Study Medication at Week 10 |
45; 46; 64 | 0.8782 |
| SECONDARY 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 |
150; 168; 166; 144; 154; 154 | — |
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
Data sourced from ClinicalTrials.gov (NCT00420641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.