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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01664260
• Other study ID #: iklnac
• Status: Withdrawn
• Phase: Phase 2
• First received: August 10, 2012
• Last updated: February 8, 2018
• Start date: November 1, 2012
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2018
• Source: Ewha Womans University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach		Baseline, 8th weeks
Primary	Change from baseline in Clinician-administered PTSD scale scores at 4th weeks		Baseline, 4th weeks
Primary	Change from baseline in Clinician-administered PTSD scale scores at 8th weeks		Baseline, 8th weeks
Secondary	Change from baseline in Hamilton depression rating scale scores at 4th weeks		Baseline, 4th weeks
Secondary	Change from baseline in Hamilton depression rating scale scores at 8th weeks		Baseline, 8th weeks
Secondary	Change from baseline in Hamilton anxiety rating scale scores at 4th weeks		Baseline, 4th weeks
Secondary	Change from baseline in Hamilton anxiety rating scale scores at 8th weeks		Baseline, 8th weeks
Secondary	Number of participants with adverse events		4th weeks
Secondary	Number of participants with adverse events		8th weeks