Clinical trial NCT04597450: Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: PTSD
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Facial Affect Recognition Task
timeFrame: Day 15
measure: Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Threat Processing Task
timeFrame: Day 15
measure: Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Card Guessing Task
timeFrame: Day 15
measure: Skin Conductance Response (SCR) During fMRI Tasks
timeFrame: Day 15
measure: Skin Conductance Response (SCR) During the Threat Processing Task
timeFrame: Day 14
measure: Behavioural Measures During fMRI Tasks
timeFrame: Day 15
measure: Behavioural Measures During the Threat Processing Task
timeFrame: Day 14
measure: Sleep, Polysomnography (PSG) Parameters: Total Sleep Time (TST)
timeFrame: Day 12-13
measure: Sleep, Polysomnography (PSG) Parameters: Sleep Efficiency (SE)
timeFrame: Day 12-13
measure: Sleep, Polysomnography (PSG) Parameters: Wake-Time After Sleep-Onset (WASO)
timeFrame: Day 12-13
measure: Sleep, Polysomnography (PSG) Parameters: Sleep Onset Latency (SOL)
timeFrame: Day 12-13
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Collaborative NeuroScience Network LLC
state: California
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: