NCT04597450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2023

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

2.4 years

First QC Date

October 2, 2020

Last Update Submit

March 23, 2023

Conditions

PTSD

Outcome Measures

Primary Outcomes (11)

  • 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

Study Arms (2)

Lu AG06466

EXPERIMENTAL
Drug: Lu AG06466

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Lu AG06466DRUG

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

Lu AG06466
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • The index traumatic event that led to development of PTSD took place \>15 years or \<6 months before screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Collaborative NeuroScience Network LLC

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2020

First Posted

October 22, 2020

Study Start

September 30, 2020

Primary Completion

February 13, 2023

Study Completion

February 13, 2023

Last Updated

March 24, 2023

Record last verified: 2023-03

Locations

US(1)