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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 17, 2015
Last verified: September 2015

August 10, 2012
September 17, 2015
November 2012
December 2016   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT01664260 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
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Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder
Elucidation of Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder: An 8-week Multimodal Neuroimaging and Neurocognitive Study

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Posttraumatic Stress Disorder
  • Drug: N-acetylcysteine
    0 - 8 week: 10 mg escitalopram a day + 1200 mg N-acetylcysteine twice a day
  • Drug: Placebo
    0 - 8 week: 10 mg escitalopram a day + 1200 mg Placebo twice a day
  • Experimental: N-acetylcysteine + Escitalopram
    The subjects with posttraumatic stress disorder, treated with N-acetylcysteine in addition to escitalopram
    Intervention: Drug: N-acetylcysteine
  • Placebo Comparator: Placebo + Escitalopram
    The subjects with posttraumatic stress disorder, treated with placebo in addition to escitalopram
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
96
December 2016
December 2016   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years   (Adult)
No
Contact: Jihee H Son, RN 82-2-3277-6558 jihee.h.son@gmail.com
Korea, Republic of
 
NCT01664260
iklnac
Yes
Not Provided
Not Provided
In Kyoon Lyoo, Ewha Womans University
Ewha Womans University
Not Provided
Principal Investigator: Inkyoon Lyoo, MD, PhD, MMS Ewha Womans University
Ewha Womans University
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP