Approval Probability
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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 being developed by GSK plc for the treatment of depressive disorder. It is currently in Phase 2 clinical development, with studies conducted in healthy subjects as well as patients with depressive disorder. The drug has not been approved by regulatory authorities and remains in clinical trials.
GSK372475 is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating depressive disorder.
GSK372475 is in Phase 2 clinical development. It has completed three clinical trials, including two Phase 2 studies and one Phase 1 study, with a total enrollment of 954 participants. The drug is investigational and has not yet received regulatory approval.
GSK372475 has completed three clinical trials: NCT00420641, a Phase 2 proof-of-concept study in 492 patients with depressive disorder; NCT00448058, a Phase 2 study in 396 patients with depression; and NCT00488098, a Phase 1 bioequivalence study in 66 healthy subjects. All trials are completed.
GSK372475 is also known by the name GSK 372475, as referenced in clinical trial titles. No other alternative names have been established for this investigational drug, which is being studied for the treatment of depressive disorder.