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Orexin Receptor Antagonist

New Treatments for PTSD

Phase 2
Recruiting
Research Sponsored by U.S. Army Medical Research and Development Command
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For males, adequate birth control methods include double barrier contraception
Participant is male or female, aged ≥18 and <65 years at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial is testing new treatments for PTSD. People will be randomly assigned to receive the new treatments or a placebo. Results will be compared to see if any treatments work better.

Who is the study for?
This trial is for US military service members or veterans aged 18-65 with PTSD diagnosed by DSM-5 criteria, having a CAPS-5-R score of ≥26. Participants must have experienced trauma over 3 months ago and agree to use approved birth control methods. Exclusions include heavy alcohol use, psychotic features, unmanaged sleep apnea, recent cancer treatment (except certain skin cancers), high suicide risk, pregnancy/breastfeeding, prohibited medication use without washout period compliance.Check my eligibility
What is being tested?
The study tests Fluoxetine HCl, Daridorexant, Vilazodone HCl against placebos in a Phase 2 randomized double-blind setup. It's an adaptive platform trial where participants are assigned to cohorts; each cohort may have specific additional procedures or endpoints detailed in appendices.See study design
What are the potential side effects?
Potential side effects from the medications could include mood changes, sleep disturbances for Daridorexant; sexual dysfunction and nervous system effects like headache or tremors for Fluoxetine; and gastrointestinal issues or insomnia for Vilazodone. Placebo groups should not experience active drug side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am using two forms of birth control.
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I am between 18 and 64 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit).
Incidence of new or worsening suicidal thoughts or behaviors as measured by change in Columbia Suicide Severity Rating Scale (C-SSRS) score from baseline.
Secondary outcome measures
Frequency of serious adverse events (SAEs)
Frequency of treatment-emergent adverse events (TEAEs).
Number of participants Achieving Remission
+5 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention C DaridorexantExperimental Treatment1 Intervention
Daridorexant will be administered 50 mg once daily within 30 minutes of going to bed at least 2 hours after the last meal.
Group II: Intervention B VilazodoneExperimental Treatment1 Intervention
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. A televisit will be conducted by site personnel 1 week after each increase in dose to determine tolerability. 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.
Group III: Intervention A: Fluoxetine HClExperimental Treatment1 Intervention
Fluoxetine will be administered at 10 to 60 mg daily. The initial dose for all subjects 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 subject's dose is decreased due to tolerability, the dose will not be increased.
Group IV: Intervention C PlaceboPlacebo Group1 Intervention
A matching placebo will be administered at 50 mg daily in the same regimen as the intervention.
Group V: Intervention A PlaceboPlacebo Group1 Intervention
A matching placebo will be administered at 10 to 60 mg daily in the same regimen as the intervention.
Group VI: Intervention B PlaceboPlacebo Group1 Intervention
A matching placebo will be administered at 10 to 40 mg daily in the same regimen as the intervention.

Find a Location

Who is running the clinical trial?

CitelineUNKNOWN
3 Previous Clinical Trials
600 Total Patients Enrolled
U.S. Army Medical Research and Development CommandLead Sponsor
286 Previous Clinical Trials
245,159 Total Patients Enrolled
PPDIndustry Sponsor
159 Previous Clinical Trials
36,265 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies to partake in this trial?

"Per the clinicaltrials.gov database, this medical experiment is still open for enrollment of patients. The trial was initially announced on November 1st 2023 and recently updated on November 3rd 2023."

Answered by AI

What is the maximum number of participants accepted into this research study?

"Affirmative. According to information available on clinicaltrials.gov, this medical experiment is actively looking for participants and was initially posted in November 1st of 2023. 600 individuals need to be recruited from one site for the research to proceed."

Answered by AI

Does this research endeavor have an age limit?

"This medical trial is seeking participants who are of legal age and below the retirement threshold."

Answered by AI

What is this research endeavor's ultimate goal?

"This clinical trial will span 12 weeks and its primary outcome is to evaluate the changes in Columbia Suicide Severity Rating Scale (C-SSRS) score from baseline. As secondary outcomes, this experiment seeks to identify Frequency of treatment-emergent adverse events (TEAEs), grade their Severity, as well as record Frequency of serious adverse events (SAEs)."

Answered by AI

How can I become involved in this medical experiment?

"This trial is searching for 600 individuals aged 18 to 65 who have been diagnosed with post-traumatic stress disorder through DSM-5 criteria and a CAPS-5 screening. Additionally, participants must provide written consent along with HIPAA authorization, be affiliated with the United States military in some capacity, and use an acceptable form of birth control if they are sexually active and reproductive potential."

Answered by AI

Has the US Food and Drug Administration cleared Vilazodone as Intervention B?

"Due to the lack of information surrounding Intervention B Vilazodone efficacy, it was scored a 2 on our team's safety scale. Nevertheless, there is some data that suggests this drug could be safe for use in Phase 2 trials."

Answered by AI

Who else is applying?

What site did they apply to?
Advanced Discovery Research
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Department of Defense PTSD Adaptive Platform Trial - Master Protocol
2023. "Department of Defense PTSD Adaptive Platform Trial - Master Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05422612.
All > Prozac
~400 spots leftby Mar 2026
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