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

Purpose

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 an 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.

Condition	Intervention	Phase
Posttraumatic Stress Disorder	Drug: N-acetylcysteine Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Elucidation of Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder: An 8-week Multimodal Neuroimaging and Neurocognitive Study

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Post-Traumatic Stress Disorder

Drug Information available for: Acetylcysteine Citalopram hydrobromide Citalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach [ Time Frame: Baseline, 8th weeks ] [ Designated as safety issue: No ]
Change from baseline in Clinician-administered PTSD scale scores at 1st week [ Time Frame: Baseline, 1st week ] [ Designated as safety issue: No ]
Change from baseline in Clinician-administered PTSD scale scores at 4th weeks [ Time Frame: Baseline, 4th weeks ] [ Designated as safety issue: No ]
Change from baseline in Clinician-administered PTSD scale scores at 8th weeks [ Time Frame: Baseline, 8th weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in Hamilton depression rating scale scores at 1st week [ Time Frame: Baseline, 1st week ] [ Designated as safety issue: No ]
Change from baseline in Hamilton depression rating scale scores at 4th weeks [ Time Frame: Baseline, 4th weeks ] [ Designated as safety issue: No ]
Change from baseline in Hamilton depression rating scale scores at 8th weeks [ Time Frame: Baseline, 8th weeks ] [ Designated as safety issue: No ]
Change from baseline in Hamilton anxiety rating scale scores at 1st week [ Time Frame: Baseline, 1st week ] [ Designated as safety issue: No ]
Change from baseline in Hamilton anxiety rating scale scores at 4th weeks [ Time Frame: Baseline, 4th weeks ] [ Designated as safety issue: No ]
Change from baseline in Hamilton anxiety rating scale scores at 8th weeks [ Time Frame: Baseline, 8th weeks ] [ Designated as safety issue: No ]
Number of participants with adverse events [ Time Frame: 1st week ] [ Designated as safety issue: Yes ]
Number of participants with adverse events [ Time Frame: 4th weeks ] [ Designated as safety issue: Yes ]
Number of participants with adverse events [ Time Frame: 8th weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	96
Study Start Date:	September 2012
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: N-acetylcysteine + Escitalopram The subjects with posttraumatic stress disorder, treated with N-acetylcysteine in addition to escitalopram	Drug: N-acetylcysteine 0 - 4 week: 10 mg escitalopram a day + 1200 mg N-acetylcysteine twice a day / 5 - 8 week: 20 mg escitalopram a day + 1200 mg N-acetylcysteine twice a day
Placebo Comparator: Placebo + Escitalopram The subjects with posttraumatic stress disorder, treated with placebo in addition to escitalopram	Drug: Placebo 0 - 4 week: 10 mg escitalopram a day / 5 - 8 week: 20 mg escitalopram a day

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

20-65 year-old male or female
Posttraumatic stress disorder diagnosed by SCID-IV
Written informed consent

Exclusion Criteria:

Past or current medication treatment for posttraumatic stress disorder
Neurologic disease (eg., epilepsy, infarct, multiple sclerosis, brain tumor)
Any other axis I psychiatric disorder
IQ below 80
Contraindications to magnetic resosnance imaging (e.g., pacemaker implantation, claustrophobia, etc.)
Any current psychotropic medication
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., allerge, intolerance, etc.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664260

Contacts

Contact: Junghyun H Lee, MD, MS

82-10-3453-1744

leejunghyun1@gmail.com

Locations

Korea, Republic of
Seoul National University Hospital	Not yet recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jeong-Hwa Hong, MD 82-2-740-8096 jhhong@snu.ac.kr
Principal Investigator: Inkyoon Lyoo, MD, PhD, MMS

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator:

Inkyoon Lyoo, MD, PhD, MMS

Seoul National University Hospital

More Information

No publications provided

Responsible Party:	In Kyoon Lyoo, MD, PhD, MMS, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT01664260 History of Changes
Other Study ID Numbers:	iklnac
Study First Received:	August 10, 2012
Last Updated:	August 10, 2012
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:

Posttraumatic Stress Disorder
N-acetylcysteine
Magnetic Resonance Imaging

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Dexetimide
Citalopram
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers

Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on June 17, 2013