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Label indication Sertraline hydrochloride oral solution is indicated for the treatment of the following [See Clinical Studies (14) ] : • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD) Sertraline hydrochloride oral solution is a selective serotonin reuptake inhibitor (SSRI)… FDA label
Also known as sertraline hydrochloride
sertraline · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Sertraline/[S,S]-Reboxetine-satellite150/4 | EXPERIMENTAL | - |
| Sertraline/[S,S]-Reboxetine-satellite150/6 | EXPERIMENTAL | - |
| sertraline-satellite | ACTIVE_COMPARATOR | - |
| sertraline-main | ACTIVE_COMPARATOR | - |
| Sertraline/[S,S]-Reboxetine-satellite150/2 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Sertraline/[S,S]-Reboxetine-main | EXPERIMENTAL | - |
| [S,S]-reboxetine-main | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | Sertraline Hydrochloride Tablets 100 mg |
| 2 | ACTIVE_COMPARATOR | Zoloft® Tablets 100 mg |
| Name | Type | Description |
|---|---|---|
| sertraline/[S,S]-reboxetine | DRUG | Tablets, 50mg sertraline/2mg \[S,S\]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg \[S,S\]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/4mg \[S,S\]-reboxetine for 5 and one half weeks. |
| sertraline | DRUG | Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks. |
| Placebo | DRUG | Tablets, orally once per day for 8 weeks |
| [S,S]-reboxetine monotherapy | DRUG | Tablets, 2 mg/day orally for 3 days, followed by 4 mg/day orally for 4 and one half weeks, followed by 6mg/day for 3 weeks |
| Sertraline Hydrochloride Tablets 100 mg | DRUG | 100mg, single dose fed |
| Zoloft® Tablets 100 mg | DRUG | 100mg, single dose fed |
Inclusion Criteria: * Subjects must fulfill the criteria for MDD without psychotic features as defined by DSMIV, based on clinical assessment and confirmed by Structural Clinical Interview for DSM-IV Axis I Disorder-Clinical Version (SCID-I) plus the MDD Specifiers included in the Research Version ...
Sertraline is a small molecule drug developed by Viatris Inc. (ticker: VTRS). It is also known as Sertraline Hydrochloride Tablets 100 mg. The drug is in Phase 1 clinical development, with two completed trials in healthy volunteers.
Sertraline targets SLC6A4, also known as the serotonin transporter. It acts as an inhibitor of this target. This mechanism is characteristic of selective serotonin reuptake inhibitors.
Sertraline is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the clinical development of Sertraline Hydrochloride Tablets 100 mg.
Sertraline is in Phase 1 clinical development. Two Phase 1 trials have been completed, and there are currently no active trials. The drug is investigational and has not been approved by the FDA for any indication.
Sertraline has been studied in two completed Phase 1 trials: NCT00650325 and NCT00648856. Both trials enrolled healthy adult volunteers in the United States and compared Sertraline Hydrochloride Tablets 100 mg with Zoloft tablets 100 mg.