Back to resultsEfficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder
Primary Purpose
Posttraumatic Stress Disorder
Status
Withdrawn
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
N-acetylcysteine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, N-acetylcysteine, Magnetic Resonance Imaging
Eligibility Criteria
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
Sites / Locations
- Ewha Womans University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
N-acetylcysteine + Escitalopram
Placebo + Escitalopram
Arm Description
The subjects with posttraumatic stress disorder, treated with N-acetylcysteine in addition to escitalopram
The subjects with posttraumatic stress disorder, treated with placebo in addition to escitalopram
Outcomes
Primary Outcome Measures
Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach
Change from baseline in Clinician-administered PTSD scale scores at 4th weeks
Change from baseline in Clinician-administered PTSD scale scores at 8th weeks
Secondary Outcome Measures
Change from baseline in Hamilton depression rating scale scores at 4th weeks
Change from baseline in Hamilton depression rating scale scores at 8th weeks
Change from baseline in Hamilton anxiety rating scale scores at 4th weeks
Change from baseline in Hamilton anxiety rating scale scores at 8th weeks
Number of participants with adverse events
Number of participants with adverse events
Full Information
NCT ID
NCT01664260
First Posted
August 10, 2012
Last Updated
February 8, 2018
Sponsor
Ewha Womans University
1. Study Identification
Unique Protocol Identification Number
NCT01664260
Brief Title
Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder
Official Title
Elucidation of Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder: An 8-week Multimodal Neuroimaging and Neurocognitive Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The research project has been cancelled before any participants were enrolled.
Study Start Date
November 1, 2012 (Anticipated)
Primary Completion Date
December 1, 2016 (Anticipated)
Study Completion Date
December 31, 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Posttraumatic Stress Disorder, N-acetylcysteine, Magnetic Resonance Imaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-acetylcysteine + Escitalopram
Arm Type
Experimental
Arm Description
The subjects with posttraumatic stress disorder, treated with N-acetylcysteine in addition to escitalopram
Arm Title
Placebo + Escitalopram
Arm Type
Placebo Comparator
Arm Description
The subjects with posttraumatic stress disorder, treated with placebo in addition to escitalopram
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Description
0 - 8 week: 10 mg escitalopram a day + 1200 mg N-acetylcysteine twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0 - 8 week: 10 mg escitalopram a day + 1200 mg Placebo twice a day
Primary Outcome Measure Information:
Title
Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach
Time Frame
Baseline, 8th weeks
Title
Change from baseline in Clinician-administered PTSD scale scores at 4th weeks
Time Frame
Baseline, 4th weeks
Title
Change from baseline in Clinician-administered PTSD scale scores at 8th weeks
Time Frame
Baseline, 8th weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Hamilton depression rating scale scores at 4th weeks
Time Frame
Baseline, 4th weeks
Title
Change from baseline in Hamilton depression rating scale scores at 8th weeks
Time Frame
Baseline, 8th weeks
Title
Change from baseline in Hamilton anxiety rating scale scores at 4th weeks
Time Frame
Baseline, 4th weeks
Title
Change from baseline in Hamilton anxiety rating scale scores at 8th weeks
Time Frame
Baseline, 8th weeks
Title
Number of participants with adverse events
Time Frame
4th weeks
Title
Number of participants with adverse events
Time Frame
8th weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inkyoon Lyoo, MD, PhD, MMS
Organizational Affiliation
Ewha Womans University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ewha Womans University Medical Center
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder
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