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

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: Completed
• Conditions: PTSD
• Intervention / Treatment: Drug: Lu AG06466; Drug: Placebo

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: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	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

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Actual): February 13, 2023
• Study Completion (Actual): February 13, 2023

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID 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