Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder

Ewha Womans University

Overview

It has been suggested that N-acetylcysteine exerts neuroprotective effects by regulating neurotransmitters and cell signaling pathways. We hypothesize that oral N-acetylcysteine augmentation will help reduce symptoms in patients with posttraumatic stress disorder as well as improve cognitive functions. We also expect that the N-acetylcysteine augmentation will induce change in structural, functional, and neurochemical aspects of the brain. In this study, we plan to conduct a randomized, double-blind, placebo-controlled augmentation study with N-acetylcysteine in addition to escitalopram. We will assess the efficacy and safety of the N-acetylcysteine augmentation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Posttraumatic Stress Disorder

Interventions

N-acetylcysteineDRUG

0 - 8 week: 10 mg escitalopram a day + 1200 mg N-acetylcysteine twice a day

PlaceboDRUG

0 - 8 week: 10 mg escitalopram a day + 1200 mg Placebo twice a day

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 20-65 year-old male or female * Posttraumatic stress disorder diagnosed by SCID-IV * Written informed consent Exclusion Criteria: * Medication treatment for posttraumatic stress disorder within 2 weeks * Neurologic disease (eg., penetrating or open head injury, epilepsy, multiple sclerosis, brain tumor, cerebrovascular diseases) * Any other axis I psychiatric disorder * IQ below 80 * Contraindications to magnetic resosnance imaging (e.g., pacemaker implantation, claustrophobia, etc.) * Any psychotropic medication within 2 weeks * Unstable medical illness or severe abnormality in laboratory test at screening assessment * Women who are pregnant, breastfeeding, or planning pregnancy * History of myocardial infarction within 6 months * Current diagnosis of duodenal ulcer or asthma * Contraindications to drugs used in the study (e.g., epilepsy, uncontrolled narrow-angle glaucoma, etc.) * Allergy or intolerance to the study drug

Locations (1)

Ewha Womans University Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach

Time frame: Baseline, 8th weeks

Change from baseline in Clinician-administered PTSD scale scores at 4th weeks

Time frame: Baseline, 4th weeks

Change from baseline in Clinician-administered PTSD scale scores at 8th weeks

Time frame: Baseline, 8th weeks

Secondary Outcomes

Change from baseline in Hamilton depression rating scale scores at 4th weeks

Time frame: Baseline, 4th weeks

Change from baseline in Hamilton depression rating scale scores at 8th weeks

Time frame: Baseline, 8th weeks

Change from baseline in Hamilton anxiety rating scale scores at 4th weeks

Time frame: Baseline, 4th weeks

Change from baseline in Hamilton anxiety rating scale scores at 8th weeks

Time frame: Baseline, 8th weeks

Number of participants with adverse events

Time frame: 4th weeks

Number of participants with adverse events

Time frame: 8th weeks

Data from ClinicalTrials.gov

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