Lu AG06466 for Post Traumatic Stress Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Post Traumatic Stress DisorderLu AG06466 - Drug
Eligibility
18 - 55
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the effects of a new drug, Lu AG06466, on people with PTSD. The drug will be given in doses of 30mg.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

11 Primary · 0 Secondary · Reporting Duration: Day 12-13

Day 12-13
Sleep, Polysomnography (PSG) Parameters: Sleep Efficiency (SE)
Sleep, Polysomnography (PSG) Parameters: Sleep Onset Latency (SOL)
Sleep, Polysomnography (PSG) Parameters: Total Sleep Time (TST)
Sleep, Polysomnography (PSG) Parameters: Wake-Time After Sleep-Onset (WASO)
Day 14
Behavioural Measures During the Threat Processing Task
Skin Conductance Response (SCR) During the Threat Processing Task
Day 15
Behavioural Measures During fMRI Tasks
Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Card Guessing Task
Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Facial Affect Recognition Task
Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Threat Processing Task
Skin Conductance Response (SCR) During fMRI Tasks

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Lu AG06466
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: Lu AG06466 · Has Placebo Group · Phase 1

Lu AG06466
Drug
Experimental Group · 1 Intervention: Lu AG06466 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lu AG06466
2020
Completed Phase 1
~60

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 12-13

Who is running the clinical trial?

H. Lundbeck A/SLead Sponsor
317 Previous Clinical Trials
76,649 Total Patients Enrolled
Email contact via H. Lundbeck A/SStudy DirectorLundbeckClinicalTrials@Lundbeck.com
184 Previous Clinical Trials
57,958 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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).
You have a CAPS-5 total score ≥28 at screening and baseline.
You have alterations in arousal and reactivity, confirmed on CAPS-5.
The participant has ongoing sleep disturbances, confirmed on CAPS-5.
You are willing to discontinue all medications and washout of psychotropic medication during the study.
You do not have any MRI contraindications.

Who else is applying?

What state do they live in?
Ohio50.0%
Oregon50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Collaborative Neuroscience Network100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%