Clinical trial

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

Name

19364A

Description

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 arms

Trial start

2020-09-30

Estimated PCD

2023-02-13

Trial end

2023-02-13

Status

Completed

Phase

Early phase I

Treatment

Lu AG06466

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

Arms:

Lu AG06466

Placebo

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

Arms:

Placebo

Size

Primary endpoint

Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During 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

Day 15

Functional Magnetic Resonance Imaging (fMRI) Data: Mean Blood Oxygen Level Dependent (BOLD) Percent Signal Change During Card Guessing Task

Day 15

Skin Conductance Response (SCR) During fMRI Tasks

Day 15

Skin Conductance Response (SCR) During the Threat Processing Task

Day 14

Behavioural Measures During fMRI Tasks

Day 15

Behavioural Measures During the Threat Processing Task

Day 14

Sleep, Polysomnography (PSG) Parameters: Total Sleep Time (TST)

Day 12-13

Sleep, Polysomnography (PSG) Parameters: Sleep Efficiency (SE)

Day 12-13

Sleep, Polysomnography (PSG) Parameters: Wake-Time After Sleep-Onset (WASO)

Day 12-13

Sleep, Polysomnography (PSG) Parameters: Sleep Onset Latency (SOL)

Day 12-13

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 35, 'type': 'ACTUAL'}}

Updated at

2023-03-24

1 organization

2 products

1 indication

Organization

Product

Indication

Product