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

This study is not yet open for participant recruitment.
Verified August 2012 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01664260
First received: August 10, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  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:


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 April 17, 2014