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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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PTSD

Intervention / Treatment
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* Drug: Lu AG06466
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lu AG06466<br> | Drug: Lu AG06466<br>* Lu AG06466 - 30 mg/day, capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo - capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Facial Affect Recognition Task | fMRI parameter estimates (β-contrasts) will be extracted per participant/treatment period from task-related regions of interest (ROIs) under task-specific contrast, Facial Affect Recognition Task | Day 15 | 
| Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Threat Processing Task | fMRI parameter estimates (β-contrasts) will be extracted per participant/treatment period from task-related regions of interest (ROIs) under task-specific contrast, Threat Processing Task | Day 15 | 
| Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Card Guessing Task | fMRI parameter estimates (β-contrasts) will be extracted per participant/treatment period from task-related regions of interest (ROIs) under task-specific contrast, Card Guessing Task | Day 15 | 
| Skin Conductance Response (SCR) During fMRI Tasks | SCR in micro-Siemens | Day 15 | 
| Skin Conductance Response (SCR) During the Threat Processing Task | SCR in micro-Siemens | Day 14 | 
| Behavioural Measures During fMRI Tasks | Behavioural Response: behavioural measures rated on a 3-point scale | Day 15 | 
| Behavioural Measures During the Threat Processing Task | Behavioural Response: behavioural measures rated on a 3-point scale | Day 14 | 
| Sleep, Polysomnography (PSG) Parameters: Total Sleep Time (TST) | TST in minutes | Day 12-13 | 
| Sleep, Polysomnography (PSG) Parameters: Sleep Efficiency (SE) | SE in percent | Day 12-13 | 
| Sleep, Polysomnography (PSG) Parameters: Wake-Time After Sleep-Onset (WASO) | WASO in minutes | Day 12-13 | 
| Sleep, Polysomnography (PSG) Parameters: Sleep Onset Latency (SOL) | SOL in minutes | Day 12-13 |