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Also known as Intervention A Fluoxetine Hydrochloride (HCl)
Intervention A Fluoxetine · 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 A: Fluoxetine HCl | EXPERIMENTAL | - |
| Intervention A Placebo | PLACEBO_COMPARATOR | - |
| Intervention B Vilazodone | EXPERIMENTAL | - |
| Intervention B Placebo | PLACEBO_COMPARATOR | - |
| Intervention C Daridorexant | EXPERIMENTAL | - |
| Intervention C Placebo | PLACEBO_COMPARATOR | - |
| Intervention D SLS-002 | EXPERIMENTAL | - |
| Intervention D Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Intervention A Fluoxetine Hydrochloride (HCl) | DRUG | Fluoxetine will be administered at 10 to 60 mg daily. The initial dose for all participants will be 10 mg daily for 1 week, then increased to 20 mg daily for 2 weeks, then increased to 40 mg daily for 2 weeks, then increased to 60 mg daily for the remainder of the trial. One reduction in dose due to tolerability will be allowed. When a participant's dose is decreased due to tolerability, the dose will not be increased. |
| Intervention A Placebo | DRUG | A matching placebo will be administered at 10 to 60 mg daily in the same regimen as the intervention. |
| 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. |
| Intervention C Daridorexant | DRUG | Daridorexant will be administered 50 mg once daily. |
| Intervention C Placebo | DRUG | A matching placebo will be administered at 50 mg daily in the same regimen as the intervention. |
| Intervention D SLS-002 | DRUG | • SLS-002 will be administered via intranasal administration (one spray per nostril, per device) at 78 mg two times per week for the first eight weeks and then once a week for the last four weeks. |
| Intervention D Placebo | DRUG | A matching placebo will be administered via intranasal administration (one spray per nostril, per device) two times per week for the first eight weeks and then once a week for the last four weeks. |
Inclusion Criteria: A participant must meet all the following criteria to be eligible to participate in this study: 1. Is willing and able to provide written informed consent. 2. ≥18 and \<65 years of age at Screening. 3. Meets Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DS...
Intervention A Fluoxetine is an investigational small molecule being studied for the treatment of Post Traumatic Stress Disorder (PTSD). It is currently in Phase 2 clinical development and is not yet approved by the FDA. The drug is being evaluated in a randomized, double-blind, placebo-controlled trial.
Intervention A Fluoxetine is a small molecule being developed for Post Traumatic Stress Disorder. The specific molecular target of this drug has not been disclosed in the available information. It is being studied in a biomarker-selected patient population, suggesting a precision medicine approach to treatment.
Intervention A Fluoxetine is being developed by Adaptive Biotechnologies Corporation, a company traded on the NASDAQ under the ticker symbol ADPT. The company is conducting a Phase 2 clinical trial of this drug for Post Traumatic Stress Disorder.
Intervention A Fluoxetine is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is actively recruiting participants with Post Traumatic Stress Disorder.
Intervention A Fluoxetine is being studied in a single Phase 2 clinical trial registered as NCT05422612, titled "Department of Defense PTSD Adaptive Platform Trial - Master Protocol." This trial is recruiting 800 participants with Post Traumatic Stress Disorder in the United States and is expected to be completed in the future.
Yes, Intervention A Fluoxetine is also known as Intervention A Fluoxetine Hydrochloride (HCl). These names refer to the same investigational drug being developed by Adaptive Biotechnologies Corporation for Post Traumatic Stress Disorder.