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Also known as 323U66 SR, 323U66 (Bupropion Hydrochloride Sustained Release)
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 sustained-release formulation of bupropion hydrochloride developed by GSK plc for depressive disorders, including major depressive disorder. It is a small molecule studied in placebo-controlled, randomized, double-blind clinical trials in Japan and South Korea.
323U66 is being studied for the treatment of depressive disorders, including major depressive disorder (MDD). Clinical trials have also evaluated it in patients with depression who did not respond to selective serotonin reuptake inhibitors. It is not approved and remains in clinical development.
323U66 is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical trials evaluating the sustained-release bupropion formulation in patients with major depressive disorder and related depressive disorders in Japan and South Korea.
323U66 has reached Phase 3 development. Two Phase 3 trials have been completed, along with a Phase 2 study in patients with major depressive disorder in Japan. No trials are currently active, and the drug is investigational rather than approved.
323U66 has been studied in completed trials including NCT01138007, a Phase 3 fixed-dose study in major depressive disorder with 572 patients in Japan and South Korea, and NCT00296517, a Phase 3 study in depression not responding to SSRIs. A Phase 2 trial, NCT00330616, enrolled 35 patients in Japan.
Yes. 323U66 SR, 323U66 (bupropion hydrochloride sustained release), and the 323U66 SR 150 mg tablet all refer to the same asset. 323U66 is the sustained-release bupropion hydrochloride formulation developed by GSK plc for depressive disorders.