Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
323U66 · 3 trials · 3 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. Change from Baseline in the total score was calculated as the value at Week 8/Withdrawal minus the value at Baseline. The least squared means were estimated based on the Analysis of Covariance (ANCOVA) model including Baseline MADRS score and region as covariates.
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).
The Hamilton Rating Scale for Depression (HAM D) contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).
| Arm | Type | Description |
|---|---|---|
| 323U66 SR 150 mg cohort | EXPERIMENTAL | 323U66 SR 150 mg tablet is orally administered once in the morning and 323U66 SR 150 mg placebo tablet is orally administered once in the evening throughout the treatment phase. |
| 323U66 SR 300 mg cohort | EXPERIMENTAL | 323U66 SR 150 mg tablet is orally administered once in the morning and 323U66 SR 150 mg placebo tablet is orally administered once in the evening during the first week of the treatment phase. At the second week, 323U66 SR 300mg cohort is up-titrated to a daily dose of 323U66 SR 300 mg, administered as 323U66 SR 150 mg tablet twice daily in the morning and in the evening, and the same daily dose is maintained to administer until the end of the treatment phase. |
| Placebo cohort | PLACEBO_COMPARATOR | 323U66 SR placebo tablet is orally administered twice daily throughout the treatment phase. |
| Placebo | PLACEBO_COMPARATOR | Subjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period. |
| Bupropion SR | EXPERIMENTAL | Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg. |
| Name | Type | Description |
|---|---|---|
| 323U66 SR 150 mg tablet | DRUG | 323U66 SR 150 mg tablet is orally administered once in the morning and/or once in the evening during the teatment phase. |
| 323U66 SR 150 mg placebo tablet | DRUG | 323U66 SR 150 mg placebo tablet is orally administered once in the evening and/or once in the morning during the teatment phase. |
| 323U66 (Bupropion Hydrochloride Sustained Release) | DRUG | Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg. |
| Placebo | DRUG | Subjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period. |
| 323U66 SR | DRUG | - |
Inclusion Criteria: \[At the start time of the run-in phase\] * Subject must have a primary diagnosis of major depressive disorder as classified by the DSM-IV-TR criteria as below (however, to exclude those accompanied by comorbid psychiatric disorders), and be showing currently a symptom of depre...
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323U66 is an investigational small molecule being studied for the treatment of major depressive disorder (MDD), also referred to as depressive disorder. It is being developed by GSK plc (ticker: GSK) and has been evaluated in clinical trials in Japan and South Korea.
The specific molecular target of 323U66 is not disclosed in the available information. The drug is being studied for its effects on depressive disorders, but its mechanism of action has not been publicly detailed.
323U66 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is in clinical development for the treatment of major depressive disorder.
323U66 has completed Phase 3 clinical trials for the treatment of major depressive disorder. It is not approved by regulatory authorities and remains an investigational drug. The completed Phase 3 studies were conducted in Japan and South Korea.
323U66 has been studied in three completed clinical trials: NCT00296517, a Phase 3 study in patients with depression not responding to selective serotonin re-uptake inhibitors; NCT00330616, a Phase 2 study in Japanese patients with major depressive disorder; and NCT01138007, a Phase 3 fixed-dose study in major depressive disorder.
323U66 is also known as bupropion SR, as indicated in the clinical trial title for NCT00330616. This name is used in studies evaluating the drug for the treatment of major depressive disorder.