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Also known as Intervention B Vilazodone Hydrochloride (HCl)
Intervention B Vilazodone · 1 trial · 1 indication
A change in PTSD symptom severity from baseline as measured by CAPS-5-R Past Month. The range of the scale is 0-200. The higher the score at baseline, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome.
The C-SSRS is an assessment of suicidal ideation and behavior in clinical and research settings. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). This 5-item subscale ranges from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent).
| Arm | Type | Description |
|---|---|---|
| Intervention B Vilazodone | EXPERIMENTAL | - |
| Intervention B Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Intervention B Vilazodone Hydrochloride (HCl) | DRUG | Vilazodone HCl will be administered at 10 mg once daily for 7 days, followed by 20 mg for 7 days, followed by 40 mg for the remainder of the trial. There must be a minimum of 7 days between dosage increases. One reduction in dose due to tolerability will be allowed. After Week 8, dose reduction for tolerability is allowed, but dose increase is not allowed. |
| Intervention B Placebo | DRUG | A matching placebo will be administered at 10 to 40 mg daily in the same regimen as the intervention. |
Inclusion Criteria: No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612). Exclusion Criteria: The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612). 1\. History of treatme...
Intervention B Vilazodone is an investigational small molecule being studied for the treatment of Post Traumatic Stress Disorder (PTSD). It is currently in Phase 2 clinical development as part of a Department of Defense adaptive platform trial. The drug is being evaluated in a randomized, double-blind, placebo-controlled study.
Intervention B Vilazodone is being developed by Adaptive Biotechnologies Corporation, a company listed on the NASDAQ under the ticker symbol ADPT. The company is conducting a Phase 2 clinical trial to evaluate the drug's safety and efficacy in patients with Post Traumatic Stress Disorder.
Intervention B Vilazodone is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied in a Phase 2 trial for Post Traumatic Stress Disorder, with an enrollment target of 200 participants.
Intervention B Vilazodone is being evaluated in a single Phase 2 clinical trial registered as NCT05948579. This trial is titled "Department of Defense PTSD Adaptive Platform Trial - Intervention B - Vilazodone" and is designed as a randomized, double-blind, placebo-controlled study. The trial is not yet recruiting participants and aims to enroll 200 individuals with Post Traumatic Stress Disorder.
Yes, Intervention B Vilazodone is also known as Intervention B Vilazodone Hydrochloride (HCl). Both names refer to the same investigational drug being developed for Post Traumatic Stress Disorder. The drug is currently in Phase 2 clinical trials and has not yet received regulatory approval.