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

Ewha Womans University

Status and phase: Withdrawn; Phase 2

Conditions: Posttraumatic Stress Disorder

Treatments: Drug: N-acetylcysteine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01664260

iklnac

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

N-acetylcysteine + Escitalopram

Experimental group

Description:

The subjects with posttraumatic stress disorder, treated with N-acetylcysteine in addition to escitalopram

Treatment:

Drug: N-acetylcysteine

Placebo + Escitalopram

Placebo Comparator group

Description:

The subjects with posttraumatic stress disorder, treated with placebo in addition to escitalopram

Treatment:

Drug: Placebo