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Daridorexant 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will assess if a new medicine is safe & effective in treating PTSD. Check NCT05422612 for more info.

Who is the study for?
This trial is for individuals with PTSD who meet the criteria outlined in the Master Protocol (NCT05422612). People cannot participate if they have a history of narcolepsy or previous treatment with daridorexant.Check my eligibility
What is being tested?
The study is testing Daridorexant, a potential medication for PTSD, against a placebo. Participants will be randomly assigned to receive either Daridorexant or an inactive substance without knowing which one they are getting.See study design
What are the potential side effects?
While specific side effects for Daridorexant in this trial context aren't listed, common ones may include drowsiness, headache, and dizziness. The exact side effects will be monitored throughout the study.

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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention C DaridorexantExperimental Treatment1 Intervention
Group II: Intervention C PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

U.S. Army Medical Research and Development CommandLead Sponsor
286 Previous Clinical Trials
245,559 Total Patients Enrolled
PPDIndustry Sponsor
159 Previous Clinical Trials
36,665 Total Patients Enrolled
Berry ConsultantsOTHER
14 Previous Clinical Trials
55,981 Total Patients Enrolled

Frequently Asked Questions

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

How many individuals have signed up for the research experiment thus far?

"Affirmative. The clinicaltrial.gov portal states that this research is actively enrolling; it was posted on November 1st 2023 and updated most recently on the 3rd of the same month. 200 volunteers are required from one location to complete the study."

Answered by AI

Are there any opportunities for me to enroll in this clinical experiment?

"This clinical trial is actively looking for 200 volunteers aged 18 to 65 that suffer from post-traumatic stress disorder. Other than the general inclusion criteria outlined in NCT05422612, no additional prerequisites are required."

Answered by AI

Is Intervention C Daridorexant hazardous to people's health?

"We have assessed the safety of Intervention C - Daridorexant to be a 2 on our scale, as there is scientific evidence which indicates its security but no research confirming its efficacy yet."

Answered by AI

Does this trial permit enrolment of persons aged 50 or older?

"Participants must meet the age requirements of this medical trial, which are an 18 year minimum and 65 year maximum."

Answered by AI

What have researchers projected to be the ultimate results of this exploration?

"As per the trial's sponsor PPD, the main study metric which will be tracked for a period of 12 weeks is changes in Columbia Suicide Severity Rating Scale (C-SSRS). Additionally, further analyses on treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) categorised by system organ class and MedDRA terms shall supplement this primary outcome."

Answered by AI

Is this trial still open to new participants?

"Affirmative. According to clinicaltrials.gov, the trial is presently enrolling and has been since its posting on November 1st 2023. The study was recently updated on November 3rd 2023 with a goal of recruiting 200 patients from one site."

Answered by AI

Who else is applying?

What site did they apply to?
Advanced Discovery Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant
2023. "Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05948540.
~133 spots leftby Mar 2026
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