Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)
NCT ID: NCT04597450
Last Updated: 2023-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2020-09-30
2023-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Lu AG06466
Lu AG06466
Lu AG06466 - 30 mg/day, capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period
Placebo
Placebo
Placebo - capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period
Interventions
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Lu AG06466
Lu AG06466 - 30 mg/day, capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period
Placebo
Placebo - capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
55 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Collaborative NeuroScience Network LLC
Long Beach, California, United States
Countries
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Other Identifiers
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19364A
Identifier Type: -
Identifier Source: org_study_id
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