Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the effect of Lu AG06466 after multiple doses of 30 milligrams (mg) in participants with PTSD.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AG06466 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG06466 | Drug | Lu AG06466 - 30 mg/day, capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative NeuroScience Network LLC | Long Beach | California | 90806 | United States |
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo - capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period |
|
| 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 |