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Completed

NCT Number: NCT04597450

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

The purpose of this study is to investigate the effect of Lu AG06466 after multiple doses of 30 milligrams (mg) in participants with PTSD.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Collaborative NeuroScience Network LLC

Long Beach, California, 90806, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lu AG06466

Drug

Lu AG06466 - 30 mg/day, capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period

Placebo

Drug

Placebo - capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period

Primary outcomes

  1. Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Facial Affect Recognition Task

    Time frame: 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

  2. Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Threat Processing Task

    Time frame: 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

  3. Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Card Guessing Task

    Time frame: 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

  4. Skin Conductance Response (SCR) During fMRI Tasks

    Time frame: Day 15

    SCR in micro-Siemens

  5. Skin Conductance Response (SCR) During the Threat Processing Task

    Time frame: Day 14

    SCR in micro-Siemens

  6. Behavioural Measures During fMRI Tasks

    Time frame: Day 15

    Behavioural Response: behavioural measures rated on a 3-point scale

  7. Behavioural Measures During the Threat Processing Task

    Time frame: Day 14

    Behavioural Response: behavioural measures rated on a 3-point scale

  8. Sleep, Polysomnography (PSG) Parameters: Total Sleep Time (TST)

    Time frame: Day 12-13

    TST in minutes

  9. Sleep, Polysomnography (PSG) Parameters: Sleep Efficiency (SE)

    Time frame: Day 12-13

    SE in percent

  10. Sleep, Polysomnography (PSG) Parameters: Wake-Time After Sleep-Onset (WASO)

    Time frame: Day 12-13

    WASO in minutes

  11. Sleep, Polysomnography (PSG) Parameters: Sleep Onset Latency (SOL)

    Time frame: Day 12-13

    SOL in minutes

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2020
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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