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

PTSD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597450
• Other study ID #: 19364A
• Status: Completed
• Phase: Phase 1
• Start date: September 30, 2020
• Est. completion date: February 13, 2023

Study information

• Verified date: March 2023
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 13, 2023
• Est. primary completion date: February 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• PTSD

Intervention

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

Locations

Country	Name	City	State
United States	Collaborative NeuroScience Network LLC	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Facial Affect Recognition Task	fMRI parameter estimates (ß-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
Primary	Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Threat Processing Task	fMRI parameter estimates (ß-contrasts) will be extracted per participant/treatment period from task-related regions of interest (ROIs) under task-specific contrast, Threat Processing Task	Day 15
Primary	Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Card Guessing Task	fMRI parameter estimates (ß-contrasts) will be extracted per participant/treatment period from task-related regions of interest (ROIs) under task-specific contrast, Card Guessing Task	Day 15
Primary	Skin Conductance Response (SCR) During fMRI Tasks	SCR in micro-Siemens	Day 15
Primary	Skin Conductance Response (SCR) During the Threat Processing Task	SCR in micro-Siemens	Day 14
Primary	Behavioural Measures During fMRI Tasks	Behavioural Response: behavioural measures rated on a 3-point scale	Day 15
Primary	Behavioural Measures During the Threat Processing Task	Behavioural Response: behavioural measures rated on a 3-point scale	Day 14
Primary	Sleep, Polysomnography (PSG) Parameters: Total Sleep Time (TST)	TST in minutes	Day 12-13
Primary	Sleep, Polysomnography (PSG) Parameters: Sleep Efficiency (SE)	SE in percent	Day 12-13
Primary	Sleep, Polysomnography (PSG) Parameters: Wake-Time After Sleep-Onset (WASO)	WASO in minutes	Day 12-13
Primary	Sleep, Polysomnography (PSG) Parameters: Sleep Onset Latency (SOL)	SOL in minutes	Day 12-13