Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00733980 | A Study of the Effects of a New Antidepressant Treatment (GSK561679) in Females With Major Depressive Disorder | PHASE2 | COMPLETED | 150 | — | — | Oct 2, 2008 | Jun 18, 2010 | Nov 17, 2017 | 18 | United States |
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 |
| Name | Type | Description |
|---|---|---|
| GSK561679 | DRUG | GSK561679 |
| Placebo | OTHER | Placebo |
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...