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

Completed · Phase 1 · Has a placebo group

Conditions studied: PTSD

In brief

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

Key facts

Study ID

NCT04597450

Run by

H. Lundbeck A/S

People needed

35

Starts

2020-09-30

Expected to finish

2023-02-13

Last updated by the study team

2023-03-24

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Collaborative NeuroScience Network LLC — Long Beach, California, United States

Full record on ClinicalTrials.gov

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