Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)
- Conditions
- PTSD
- Interventions
- Drug: PlaceboDrug: Lu AG06466
- Registration Number
- NCT04597450
- Lead Sponsor
- H. Lundbeck A/S
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo - Lu AG06466 Lu AG06466 -
- Primary Outcome Measures
Name Time Method Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Facial Affect Recognition Task Day 15 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
Skin Conductance Response (SCR) During the Threat Processing Task Day 14 SCR in micro-Siemens
Behavioural Measures During fMRI Tasks Day 15 Behavioural Response: behavioural measures rated on a 3-point scale
Sleep, Polysomnography (PSG) Parameters: Total Sleep Time (TST) Day 12-13 TST in minutes
Skin Conductance Response (SCR) During fMRI Tasks Day 15 SCR in micro-Siemens
Sleep, Polysomnography (PSG) Parameters: Wake-Time After Sleep-Onset (WASO) Day 12-13 WASO in minutes
Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Threat Processing Task Day 15 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
Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Card Guessing Task Day 15 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
Sleep, Polysomnography (PSG) Parameters: Sleep Efficiency (SE) Day 12-13 SE in percent
Sleep, Polysomnography (PSG) Parameters: Sleep Onset Latency (SOL) Day 12-13 SOL in minutes
Behavioural Measures During the Threat Processing Task Day 14 Behavioural Response: behavioural measures rated on a 3-point scale
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Collaborative NeuroScience Network LLC
🇺🇸Long Beach, California, United States