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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Seoul National University Hospital.
Recruitment status was  Not yet recruiting
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
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: 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 August 20, 2014