NCT05948553

Brief Summary

This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design. Intervention A - Fluoxetine will assess the safety and efficacy of fluoxetine in participants with PTSD. Please see NCT05422612 for information on the S-21-02 Master Protocol.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
3mo left

Started Nov 2023

Typical duration for phase_2

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Nov 2023Sep 2026

First Submitted

Initial submission to the registry

July 5, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 2, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

July 5, 2023

Last Update Submit

September 5, 2025

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

  • Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit).

    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.

    12 Weeks

  • Incidence of new or worsening suicidal thoughts or behaviors as measured by change in Columbia Suicide Severity Rating Scale (C-SSRS) score from baseline.

    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).

    12 Weeks

Secondary Outcomes (8)

  • Frequency of treatment-emergent adverse events (TEAEs).

    12 Weeks

  • Severity of treatment-emergent adverse events (TEAEs).

    12 Weeks

  • Frequency of serious adverse events (SAEs).

    12 Weeks

  • Severity of serious adverse events (SAEs).

    12 Weeks

  • Relative change from Baseline to Week 12 in the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score.

    12 Weeks

  • +3 more secondary outcomes

Study Arms (2)

Intervention A: Fluoxetine HCl

EXPERIMENTAL
Drug: Intervention A Fluoxetine Hydrochloride (HCl)

Intervention A Placebo

PLACEBO COMPARATOR
Drug: Intervention A Placebo

Interventions

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: Fluoxetine HCl
Intervention A PlaceboDRUG

A matching placebo will be administered at 10 to 60 mg daily in the same regimen as the intervention.

Intervention A Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsParticipants who have undergone or plans to undergo gender reassignment surgery are not eligible. Participants who are currently undergoing stable hormone replacement therapy are eligible for inclusion in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • \. Recent history of treatment for PTSD with fluoxetine at doses of 20 mg daily, for at least 4 weeks. A remote history of treatment with fluoxetine for non-PTSD symptoms will be discussed on a case-by-case basis with the contract research organization (CRO) Medical Monitor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Phoenix VA Healthcare System

Phoenix, Arizona, 85012-1839, United States

RECRUITING

Homestead Associates in Research, Inc.

Miami, Florida, 33032, United States

RECRUITING

Advanced Discovery Research

Atlanta, Georgia, 30318, United States

RECRUITING

Tripler Army Medical Center (TAMC)

Tripler AMC, Hawaii, 96859, United States

RECRUITING

Cincinnati Veteran's Affairs Medical Center

Fort Thomas, Kentucky, 41075, United States

RECRUITING

Walter Reed National Military Medical Center (WRNMC)

Bethesda, Maryland, 20889-5632, United States

RECRUITING

Upstate Clinical Research Associates, LLC

Williamsville, New York, 14221, United States

RECRUITING

Wilford Hall Ambulatory Surgical Center (WHASC)

San Antonio, Texas, 78236, United States

RECRUITING

Alexander T. Augusta Military Medical Center (ATAMMC):

Fort Belvoir, Virginia, 22060-5285, United States

RECRUITING

Madigan Army Medical Center

Joint Base Lewis McChord, Washington, 98433, United States

RECRUITING

Related Publications (1)

  • Viele K. Allocation in platform trials to maintain comparability across time and eligibility. Stat Med. 2023 Jul 20;42(16):2811-2818. doi: 10.1002/sim.9750. Epub 2023 Apr 23.

    PMID: 37088912BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Central Study Contacts

Please visit the website:

CONTACT

ptsdclinicaltrial.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The overall 2-stage randomization scheme will be implemented by an unblinded statistician who is otherwise uninvolved in study operations. Participants will be assigned a study number at Screening (Subject ID). In the first stage of randomization, eligible participants who complete screening will be randomly assigned to an open platform cohort for which they are eligible (both site PIs and participants are aware of the cohort assignment) and, within that cohort, the second stage of randomization is to intervention vs placebo (double-blind) using Interactive Response Technology (IRT). For this APT, participants assignment to a cohort will not be blinded. The tablets/capsules used in the cohorts may not be visually similar between cohorts and blinding to cohort assignment is not necessary to avoid bias. However, within each cohort, participants, site personnel, contract research personnel and the sponsor will be blind to treatment assignment (intervention vs. placebo).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Fluoxetine is one of multiple interventions that will be tested in this adaptive platform trial (NCT05422612).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2023

First Posted

July 17, 2023

Study Start

November 2, 2023

Primary Completion

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

September 8, 2025

Record last verified: 2025-09

Locations

US(10)