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

Phase 2

Withdrawn

• Conditions: Posttraumatic Stress Disorder
• Interventions: Drug: N-acetylcysteine; Drug: Placebo

• Registration Number: NCT01664260
• Lead Sponsor: Ewha Womans University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-14
• Study Start: 2012-11-01
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-31
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-08
• Last Update Posted: 2018-02-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-acetylcysteine + Escitalopram	N-acetylcysteine	The subjects with posttraumatic stress disorder, treated with N-acetylcysteine in addition to escitalopram
Placebo + Escitalopram	Placebo	The subjects with posttraumatic stress disorder, treated with placebo in addition to escitalopram

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	8th weeks
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

Trial Locations

Locations (1)

Ewha Womans University Medical Center; 🇰🇷 Seoul, Korea, Republic of