Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK561679 · 2 trials · 2 indications
The Bech Melancholia Sub-scale is extracted from the HAMD-17 and is comprised of the following 6 items: Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic, and Somatic Symptoms General. The items Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic are scored on a 5-point scale from 0 to 4 except for Somatic Symptoms General which is scored on a 3-point scale from 0 to 2 where the higher scores reflecting greater severity. The Bech Melancholia Scale total score is calculated by summing the individual response scores. The highest possible score is 22 (indicative of greater severity) and the lowest possible score is 0 (indicating absence of symptoms). Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0.
| Arm | Type | Description |
|---|---|---|
| GSK561679 arm | EXPERIMENTAL | Double blind GSK561679 |
| placebo arm | PLACEBO_COMPARATOR | Double blind placebo |
| GW876008 | EXPERIMENTAL | The subjects will be randomized to one of the six sequences A/B/D A/D/B B/A/D B/D/A D/A/B D/B/A across three treatment periods where A represents placebo, B represents GW876008 and D represents alprazolam. |
| GSK561679 | EXPERIMENTAL | The subjects will be randomized to one of the six sequences A/C/D A/D/C C/A/D C/D/A D/A/C D/C/A across three treatment periods where A represents placebo, C represents GSK561679 and D represents alprazolam. |
| Name | Type | Description |
|---|---|---|
| GSK561679 | DRUG | GSK561679 |
| Placebo | OTHER | Placebo |
| GSK561679 tablet | DRUG | GSK561679 tablets are white film-coated tablets, containing 200 (milligrams) mg of the free base, GSK561679A. |
| GW876008 tablet | DRUG | GW876008 tablets are white to off-white round film-coated tablets, containing 100 mg of GW876008X (free base). |
| alprazolam | DRUG | Alprazolam capsules 0.25 mg are hard gelatine capsules containing 1 tablet of commercial alprazolam (Xanax 0.25). |
Inclusion criteria: * Female outpatients aged 25-64 years, inclusive. * Subjects must have the ability to comprehend the consent form, and provide informed consent. * Subject currently meets the diagnosis for MDD (without psychotic features), single episode or recurrent, as defined in the DSM-IV-TR...
GSK561679 is an investigational small molecule being studied for psychiatric conditions, including major depressive disorder, social phobia, and use in healthy subjects. It has been evaluated in clinical trials for these indications, with the most advanced study being a Phase 2 trial in females with major depressive disorder.
GSK561679 is a small molecule being developed for psychiatric indications. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for its potential effects on major depressive disorder and social phobia.
GSK561679 is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker symbol GSK. GSK is conducting clinical trials to evaluate the drug's safety and efficacy in psychiatric conditions.
GSK561679 is in Phase 2 clinical development. A Phase 2 trial in females with major depressive disorder has been completed. Earlier Phase 1 studies in healthy subjects and in individuals with social phobia have also been completed.
GSK561679 has been studied in three completed clinical trials. NCT00733980 is a Phase 2 study in females with major depressive disorder. NCT00555139 is a Phase 1 study in social phobia. NCT00539136 is a Phase 1 study in healthy male volunteers.
GSK561679 is the primary name used for this investigational drug in clinical trial registrations. No alternative names have been identified in the available trial information. The drug is being developed by GSK plc under this designation.