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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

Must not have

Participant has a current diagnosis of obstructive sleep apnea considered not well-managed

Participant has undergone or plans to undergo gender reassignment surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My sleep apnea is currently not well-managed.

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I have had or plan to have gender reassignment surgery.

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I have had cancer or finished cancer treatment within the last 5 years.

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My recent tests show my kidneys or liver are not working well.

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I am not taking any medication that is not allowed in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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.

0 / 7Eligibility criteria met