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

NCT ID: NCT01664260

Last Updated: 2018-02-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-01
• Study Completion Date: 2016-12-31

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

N-acetylcysteine + Escitalopram

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

Group Type: EXPERIMENTAL

N-acetylcysteine

Intervention Type: DRUG

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

Placebo + Escitalopram

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

N-acetylcysteine

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ewha Womans University

OTHER

Sponsor Role: lead

Responsible Party

In Kyoon Lyoo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Inkyoon Lyoo, MD, PhD, MMS

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University

Locations

Ewha Womans University Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

iklnac

Identifier Type: -

Identifier Source: org_study_id