Trials / Completed
CompletedNCT04597450
Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)
Interventional, Randomized, Double-Blind, Crossover, Placebo-Controlled, Exploratory Study Investigating the Effects of Lu AG06466 on BOLD fMRI Signals and Sleep Parameters in Patients With PTSD
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- H. Lundbeck A/S · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lu AG06466 | Lu AG06466 - 30 mg/day, capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period |
| DRUG | Placebo | Placebo - capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period |
Timeline
- Start date
- 2020-09-30
- Primary completion
- 2023-02-13
- Completion
- 2023-02-13
- First posted
- 2020-10-22
- Last updated
- 2023-03-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04597450. Inclusion in this directory is not an endorsement.