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

March 23, 2023 updated by: H. Lundbeck A/S

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90806
        • Collaborative NeuroScience Network LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo - capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period
Experimental: Lu AG06466
Drug: Lu AG06466
Lu AG06466 - 30 mg/day, capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 15
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
Day 15
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
Day 15
Skin Conductance Response (SCR) During fMRI Tasks
Time Frame: Day 15
SCR in micro-Siemens
Day 15
Skin Conductance Response (SCR) During the Threat Processing Task
Time Frame: Day 14
SCR in micro-Siemens
Day 14
Behavioural Measures During fMRI Tasks
Time Frame: Day 15
Behavioural Response: behavioural measures rated on a 3-point scale
Day 15
Behavioural Measures During the Threat Processing Task
Time Frame: Day 14
Behavioural Response: behavioural measures rated on a 3-point scale
Day 14
Sleep, Polysomnography (PSG) Parameters: Total Sleep Time (TST)
Time Frame: Day 12-13
TST in minutes
Day 12-13
Sleep, Polysomnography (PSG) Parameters: Sleep Efficiency (SE)
Time Frame: Day 12-13
SE in percent
Day 12-13
Sleep, Polysomnography (PSG) Parameters: Wake-Time After Sleep-Onset (WASO)
Time Frame: Day 12-13
WASO in minutes
Day 12-13
Sleep, Polysomnography (PSG) Parameters: Sleep Onset Latency (SOL)
Time Frame: Day 12-13
SOL in minutes
Day 12-13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
H. Lundbeck A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19364A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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