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Also known as Paroxetine hydrochloride, Paroxetine CR
Paroxetine · 8 trials · 7 indications
A standard 12-lead electrocardiogram (ECG) were recorded in a participant using an ECG machine after 10 minutes rest in the supine position. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value.
Blood samples were collected at indicated time points for the analysis of Cmax of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Blood samples were collected at indicated time points for the analysis of AUC(0-t) of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Blood samples were collected at indicated time points for the analysis of AUC(0-inf) of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Blood samples were collected at indicated time points for the analysis of %AUCex of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Blood samples were collected at indicated time points for the analysis of Tmax of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Blood samples were collected at indicated time points for the analysis of t1/2 of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Blood samples were collected at indicated time points for the analysis of Kel of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
| Arm | Type | Description |
|---|---|---|
| Paroxetine | OTHER | A 52-week, non-comparative, uncontrolled study (However, the baseline phase is single blind) |
| Placebo | PLACEBO_COMPARATOR | - |
| Paroxetine hydrochloride followed by PAXIL | EXPERIMENTAL | - |
| PAXIL followed by paroxetine hydrochloride | EXPERIMENTAL | - |
| Open label treatment with 2-period crossover design | EXPERIMENTAL | Group 1: Paroxetine CR 25 mg/day for 14 days / Paroxetine IR 20 mg/day for 14 days. Group 2: Paroxetine IR 20 mg/day for 14 days / Paroxetine CR 25 mg/day for 14 days., PK results will be compared between the Paroxetine CR treatment period and the Paroxetine IR treatment period. |
| Name | Type | Description |
|---|---|---|
| Paroxetine CR | DRUG | - |
| Paroxetine IR | DRUG | - |
| Paroxetine | DRUG | Subjects will take the treatment phase medication once daily after an evening meal. All subjects will be maintained at Dose Level II (20 mg/day) for the first 2 weeks. If a sufficient clinical response ("1. Very much improved" or "2. Much improved" based on the CGI Global Improvement) is achieved, the subject will continue on the same dose level. When the clinical response is not sufficient but the investigational product is well tolerated, the dose will be increased to Dose Level III (30 mg/day) and then to Dose Level IV (40 mg/day) at intervals of at least 2 weeks until a sufficient response is reached. Once a sufficient response is obtained, the treatment will be continued at that dose. The treatment phase will last for a total of 52 weeks. In those patients receiving Dose Level III or IV, dosage reductions to the next lowest level (Dose Level II or III) consequent to an adverse event are permitted. Dosage adjustment will be made at the discretion of the PI or Sub-PI |
| Placebo | DRUG | Placebo |
| Paroxetine hydrochloride | DRUG | Paroxetine hydrochloride will be administered. |
| PAXIL (Paroxetine hydrochloride ) | DRUG | PAXIL will be administered. |
| Paroxetine CR and Paroxetine IR | DRUG | Randomized, 2-period crossover repeat dosing of Paroxetine CR at 25 mg/day for 14 days and Paroxetine IR at 20 mg/day for 14 days in Japanese healthy male volunteers |
Inclusion Criteria: * Patients with Major Depressive Disorder,score on depression rating scale reach a specific point(17 item Hamilton Depression Scale\>18). Exclusion criteria: * patients use monoamine oxidase inhibitors (MAOIs), benzodiazepines, Chinese herbal medicines, acupuncture, moxibustio...
Paroxetine is a small molecule drug developed by GSK plc (ticker GSK) for psychiatric conditions including anxiety disorder, depressive disorder, major depressive disorder, post-traumatic stress disorder, and social anxiety disorder. It is an inhibitor of the serotonin transporter SLC6A4 and is studied in both controlled-release and immediate-release tablet forms.
Paroxetine is used for anxiety disorder, depressive disorder, major depressive disorder, post-traumatic stress disorder, and social anxiety disorder. It is a small molecule developed by GSK plc and has been evaluated in clinical trials for these psychiatric indications, including a Phase 3 study in post-traumatic stress disorder.
Paroxetine targets SLC6A4, the serotonin transporter, and acts as an inhibitor of this target. By inhibiting SLC6A4, paroxetine affects serotonergic signaling in the central nervous system, which is the basis for its study in anxiety and depressive disorders.
Paroxetine is developed by GSK plc, which trades under the ticker GSK. GSK is the company associated with the clinical development program for paroxetine across anxiety, depressive, and stress-related psychiatric indications.
Paroxetine is in Phase 2 development according to its current development stage, and it is investigational. Clinical trials of paroxetine have been conducted across Phase 1 and Phase 3, including completed studies in healthy volunteers and a completed Phase 3 trial in post-traumatic stress disorder.
Paroxetine has been studied in completed trials including NCT06065735, a concentration-QT study in healthy adults; NCT04311463, a bioequivalence study in healthy Mexican participants; NCT01000857, a repeat-dose study in healthy Japanese male subjects; and NCT00839397, a Phase 3 trial in post-traumatic stress disorder.
Yes, Paroxetine is also known as paroxetine hydrochloride, and it is marketed and studied in formulations including paroxetine CR and paroxetine IR, with a paroxetine CR 12.5 mg tablet also referenced. These names refer to the same active drug developed by GSK plc.