Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)

  • STATUS
    Recruiting
  • End date
    Mar 14, 2023
  • participants needed
    30
  • sponsor
    H. Lundbeck A/S
Updated on 29 June 2022

Summary

The purpose of this study is to investigate the effect of Lu AG06466 after multiple doses of 30 milligrams (mg) in participants with PTSD.

Description

The crossover study consists of two treatment periods of 15 days duration. On Day -1 or Day 1 of Treatment Period 1, eligible participants will be randomized (1:1) to a sequence of treatments (either Lu AG06466-placebo or placebo-Lu AG06466) with 15 participants are planned per sequence. Each treatment period will be separated by a washout period of ≥7 and ≤14 days.

Details
Condition PTSD
Treatment Placebo, Lu AG06466
Clinical Study IdentifierNCT04597450
SponsorH. Lundbeck A/S
Last Modified on29 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The participant has PTSD, diagnosed according to Diagnostic and Statistical Manual Diploma in Social Medicine-5 (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview (MINI)
The participant has a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score ≥28 at screening and baseline
The participant has alterations in arousal and reactivity, confirmed on CAPS-5
The participant has ongoing sleep disturbances, confirmed on CAPS-5
The participant is willing to discontinue all prohibited medications during the study and to complete a washout of psychotropic medication during the washout period
The participant does not have any magnetic resonance imaging (MRI) contraindications

Exclusion Criteria

The index traumatic event that led to development of PTSD took place >15 years or <6 months before screening
Other inclusion and exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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