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

Elucidation of Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder: An 8-week Multimodal Neuroimaging and Neurocognitive Study

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 Overview

• Status: Withdrawn
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Drug: N-acetylcysteine; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 158-710
    • Ewha Womans University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: N-acetylcysteine + Escitalopram; The subjects with posttraumatic stress disorder, treated with N-acetylcysteine in addition to escitalopram	Drug: N-acetylcysteine; 0 - 8 week: 10 mg escitalopram a day + 1200 mg N-acetylcysteine twice a day
Placebo Comparator: Placebo + Escitalopram; The subjects with posttraumatic stress disorder, treated with placebo in addition to escitalopram	Drug: Placebo; 0 - 8 week: 10 mg escitalopram a day + 1200 mg Placebo twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach	Baseline, 8th weeks
Change from baseline in Clinician-administered PTSD scale scores at 4th weeks	Baseline, 4th weeks
Change from baseline in Clinician-administered PTSD scale scores at 8th weeks	Baseline, 8th weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Hamilton depression rating scale scores at 4th weeks	Baseline, 4th weeks
Change from baseline in Hamilton depression rating scale scores at 8th weeks	Baseline, 8th weeks
Change from baseline in Hamilton anxiety rating scale scores at 4th weeks	Baseline, 4th weeks
Change from baseline in Hamilton anxiety rating scale scores at 8th weeks	Baseline, 8th weeks
Number of participants with adverse events	4th weeks
Number of participants with adverse events	8th weeks

Collaborators and Investigators

• Sponsor: Ewha Womans University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2012
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 31, 2016

Study Registration Dates

• First Submitted: August 10, 2012
• First Submitted That Met QC Criteria: August 10, 2012
• First Posted (Estimate): August 14, 2012

Study Record Updates

• Last Update Posted (Actual): February 9, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Posttraumatic Stress Disorder; N-acetylcysteine
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: iklnac