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Label indication Wellbutrin XL is an aminoketone antidepressant, indicated for: • treatment of major depressive disorder (MDD) ( 1.1 ) • prevention of seasonal affective disorder (SAD) ( 1.2 ) 1.1 Major Depressive Disorder (MDD) Wellbutrin XL ® (bupropion hydrochloride extended-release) tablets is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). FDA label
Also known as Extended-release Bupropion Hydrochloride, Extended-release bupropion (HCl)
Bupropion · 7 trials · 6 indications
HAMD-17 is used to assess the severity of depression and symptom improvement. It consisted of 17 questions. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Change from Baseline was calculated by subtracting the Baseline total score (at Day 0, Week 0) from Week 8 observed total score. The Per Protocol (PP) Population is defined as all randomized participants in the Intent-To-Treat (ITT) Population who do not meet criteria of a major protocol deviation, with overall compliance of active drug for acute treatment phase in the range of 75%-125% and complete the first 6 weeks treatment and has HAMD-17 assessment at/after week 6 (that is \>=35 days). All participants in the PP population were included in the mixed model repeated measures analysis. Only those participants with data available at the specified time point were analyzed.
| Arm | Type | Description |
|---|---|---|
| Bupropion Treatment Arm | EXPERIMENTAL | Subject will receive bupropion in 3 dose levels along with escitalopram matching placebo to maintain the blind in acute treatment phase. At dose level 1 (Week 0 to Week 1), Subjects will receive bupropion XL 150 milligram (mg) per day for a week. At dose level 2 (Week 1 to Week 4), bupropion XL dose will be increased to 300mg/day for further 3 weeks. At dose level 3 (Week 4 to Week 8), bupropion XL dose will be maintained at 300mg/day. Subjects intolerable to dose level 3 will be allowed to down titrate to dose level 2 at anytime, and maintain the dose until the end of acute treatment phase (Week 8, Visit 7). At the end of acute treatment phase, the dose of bupropion XL will be reduced to 150mg/day for 1 week before discontinuation. |
| Escitalopram Treatment Arm | ACTIVE_COMPARATOR | Subject will receive escitalopram in 3 dose levels along with bupropion matching placebo to maintain the blind in acute treatment phase. At dose level 1 (Week 0 to Week 1), Subjects will receive escitalopram 10mg/day for a week. At dose level 2 (Week 1 to Week 4), escitalopram dose will be maintained at 10mg/day for further 3 weeks. At dose level 3 (Week 4 to Week 8), escitalopram dose will be increased to 20mg/day. Subjects intolerable to dose level 3 will be allowed to down titrate to dose level 2 at anytime, and maintain the dose until the end of acute treatment phase (Week 8, Visit 7). At the end of acute treatment phase, the dose of escitalopram 20mg/day, the dose will be reduced to 10 mg/day for 1 week before discontinuation, while those receiving 10mg/day will discontinuation directly. |
| Extended-release Bupropion Hydrochloride | OTHER | Extended-release Bupropion Hydrochloride |
| Name | Type | Description |
|---|---|---|
| Bupropion | DRUG | Bupropion is an extended-release plain creamy white colored tablet which contains bupropion hydrochloride equivalent to 150 mg of bupropion. |
| Bupropion Matching Placebo | DRUG | Bupropion hydrochloride matching placebo tablets will be supplied to maintain blinding |
| Escitalopram | DRUG | Escitalopram is available as a Swedish orange capsule containing escitalopram oxalate equivalent to 10 mg of escitalopram. |
| Escitalopram Matching Placebo | DRUG | Escitalopram oxalate matching placebo tablets will be supplied to maintain blinding |
| Extended-release bupropion (HCl) | DRUG | - |
| Extended-Release Bupropion Hydrochloride | DRUG | - |
Inclusion Criteria: * Subjects must have the ability to effectively communicate with investigator, complete study related documents, comprehend the key components of the consent form and must provide written informed consent to participate in the study prior to any study-specific assessments or pro...
Extended-release bupropion hydrochloride is a small molecule drug developed by GSK plc (ticker GSK). It is studied in psychiatry across several conditions, including major depressive disorder, seasonal affective disorder, attention deficit disorder, epilepsy, and depressive disorder. The program has completed Phase 3 trials, with two completed studies and no active trials currently listed.
Bupropion is studied for major depressive disorder, seasonal affective disorder, attention deficit disorder, epilepsy, and depressive disorder. Its clinical program includes completed Phase 1 and Phase 3 studies in adults with depressive disorders and major depressive disorder. It is an investigational therapy in these indications rather than a confirmed approved treatment based on this program data.
Bupropion targets SLC6A3 and SLC6A2, and it acts as an inhibitor of these targets. SLC6A3 is the dopamine transporter and SLC6A2 is the norepinephrine transporter, so the drug inhibits reuptake of dopamine and norepinephrine. This target profile underlies its study in psychiatric and neurological conditions.
GSK plc, which trades under the ticker GSK, is the developer of extended-release bupropion hydrochloride. The company has sponsored the clinical program, including completed Phase 1 and Phase 3 trials in depressive disorders and major depressive disorder conducted in the United States.
Bupropion is in Phase 3 development. Its program includes two completed trials, one Phase 1 study and one Phase 3 study, with no active trials listed. The Phase 3 trial NCT00064467 enrolled 268 participants and studied epilepsy and major depressive disorder in adults.
Completed bupropion trials include NCT00069459, a Phase 1 seasonal affective depression study with 250 participants, and NCT00064467, a Phase 3 lethargic depression study with 268 participants. Two additional completed Phase 3 studies, NCT00051272 and NCT00051259, examined antidepressant effects on sexual functioning in adults with major depressive disorder.