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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Ewha Womans University
Sponsor:
Information provided by (Responsible Party):
In Kyoon Lyoo, Ewha Womans University
ClinicalTrials.gov Identifier:
NCT01664260
First received: August 10, 2012
Last updated: March 4, 2015
Last verified: March 2015
  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 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.


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:


Further study details as provided by Ewha Womans University:

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 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 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 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: 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: November 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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 - 8 week: 10 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 - 8 week: 10 mg escitalopram a day + 1200 mg Placebo twice 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., 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 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., epilepsy, uncontrolled narrow-angle glaucoma, etc.)
  • Allergy of intolerence to the study drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Jihee H Son, RN 82-2-3277-6554 jihee.h.son@gmail.com

Locations
Korea, Republic of
Ewha Womans University Medical Center Recruiting
Seoul, Korea, Republic of, 158-710
Contact: Jieun E Kim, MD, PhD    82-2-3277-6550    jieunekim@gmail.com   
Principal Investigator: Inkyoon Lyoo, MD, PhD, MMS         
Sponsors and Collaborators
Ewha Womans University
Investigators
Principal Investigator: Inkyoon Lyoo, MD, PhD, MMS Ewha Womans University
  More Information

No publications provided

Responsible Party: In Kyoon Lyoo, Professor, Ewha Womans University
ClinicalTrials.gov Identifier: NCT01664260     History of Changes
Other Study ID Numbers: iklnac
Study First Received: August 10, 2012
Last Updated: March 4, 2015
Health Authority: South Korea: The Ministry of Food and Drug Safety(MFDS)

Keywords provided by Ewha Womans University:
Posttraumatic Stress Disorder
N-acetylcysteine
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Acetylcysteine
Citalopram
Dexetimide
N-monoacetylcystine
Anti-Dyskinesia Agents
Anti-Infective Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antidotes
Antioxidants
Antiparkinson Agents
Antiviral Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Expectorants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 05, 2015