Xenon Inhalation for Treatment of Posttraumatic Stress Disorder

N

Nobilis Therapeutics

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Post Traumatic Stress Disorder

Treatments

Combination Product: Placebo
Combination Product: NBTX-001 Xenon Inhaler

Study type

Interventional

Funder types

Industry

Identifiers

NCT03635827
NBTX-001

Details and patient eligibility

About

This study is a double-blind, randomized, placebo-controlled, clinical trial in parallel groups in patients with PTSD.

Enrollment

190 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with a current diagnosis of PTSD (documented diagnosis of PTSD based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [DSM-5] criteria and a Clinician Administered PTSD Scale [CAPS-5] total severity score of >30).
  • Male and female patients between the ages of 18 and 85 years.

Exclusion criteria

  • History of schizophrenia, bipolar and other psychotic disorders.
  • Patients with underlying pulmonary disease, chronic obstructive pulmonary disease (COPD), asthma or any other respiratory conditions / diseases that may affect the respiratory function.
  • Currently undergoing PTSD-targeted psychotherapy.
  • Currently undergoing exposure-based psychotherapy for any condition.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

190 participants in 2 patient groups, including a placebo group

NBTX-001
Active Comparator group
Treatment:
Combination Product: NBTX-001 Xenon Inhaler
Placebo
Placebo Comparator group
Treatment:
Combination Product: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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