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GSK372475 · 4 trials · 2 indications
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| GSK372475 | EXPERIMENTAL | flexible-dose design from GSK372475 1.0 mg/day to GSK372475 2.0 mg/day |
| Venlafaxine | ACTIVE_COMPARATOR | Flexible- dose design from Venlafaxine XR 75 mg/day to Venlafaxine XR 225 mg/day |
| placebo | PLACEBO_COMPARATOR | - |
| GSK372475 Arm | EXPERIMENTAL | GSK372475 1.0- 1.5 mg/day |
| Paroxetine Arm | EXPERIMENTAL | Paroxetine 20-30 mg/day |
| Name | Type | Description |
|---|---|---|
| GSK372475 | DRUG | daily administration during the 10-week treatment phase |
| venlafaxine | DRUG | daily administration during the 10-week treatment phase |
| placebo | DRUG | daily administration during the 10-week treatment phase |
| Paroxetine | DRUG | Paroxetine 20-30 mg/day |
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 ...
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GSK372475 is an investigational small molecule developed by GSK plc for the treatment of depressive disorder. It has been studied in four completed clinical trials, including two Phase 2 studies in patients with depression and two Phase 1 studies in healthy volunteers. It is not approved and remains in clinical development.
GSK372475 was studied as a treatment for depressive disorder, including major depressive disease. Two Phase 2 trials evaluated it in patients with depression, one titled a study of new medicine for the treatment of depression and one a major depressive disorder proof of concept study. It is investigational and not approved for any use.
GSK372475 is developed by GSK plc, which trades under the ticker GSK. The company sponsored all four registered clinical trials of the compound, spanning Phase 1 pharmacokinetic and bioequivalence work in healthy volunteers and Phase 2 studies in patients with depressive disorder.
GSK372475 reached Phase 2, the most advanced stage recorded for the compound. Two Phase 2 trials were completed in depressive disorder, alongside two completed Phase 1 studies. No active trials are ongoing, and the drug is investigational rather than approved.
Four completed trials are registered for GSK372475. Phase 1 studies include NCT00728208, a pharmacokinetic study in healthy volunteers in Germany, and NCT00488098, a bioequivalence study in Canada. Phase 2 studies include NCT00448058 in depression and NCT00420641, a major depressive disorder proof of concept study.
Across the four completed trials, 1,020 participants were enrolled. The two Phase 2 depression studies accounted for the largest groups, with 396 participants in NCT00448058 and 492 in NCT00420641. The two Phase 1 studies each enrolled 66 healthy volunteers. All trials were randomized and double blind.