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

Study Overview
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Brief Summary
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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.

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

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Drug: N-acetylcysteine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic Stress Disorder, N-acetylcysteine, Magnetic Resonance Imaging