Clinical trial NCT01664260: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Posttraumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder
N-acetylcysteine
Magnetic Resonance Imaging
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2012-08-14
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach
timeFrame: Baseline, 8th weeks
measure: Change from baseline in Clinician-administered PTSD scale scores at 4th weeks
timeFrame: Baseline, 4th weeks
measure: Change from baseline in Clinician-administered PTSD scale scores at 8th weeks
timeFrame: Baseline, 8th weeks
Secondary outcomes:
measure: Change from baseline in Hamilton depression rating scale scores at 4th weeks
timeFrame: Baseline, 4th weeks
measure: Change from baseline in Hamilton depression rating scale scores at 8th weeks
timeFrame: Baseline, 8th weeks
measure: Change from baseline in Hamilton anxiety rating scale scores at 4th weeks
timeFrame: Baseline, 4th weeks
measure: Change from baseline in Hamilton anxiety rating scale scores at 8th weeks
timeFrame: Baseline, 8th weeks
measure: Number of participants with adverse events
timeFrame: 4th weeks
measure: Number of participants with adverse events
timeFrame: 8th weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Medical Center
Study officials:
affiliation: Ewha Womans University
name: Inkyoon Lyoo, MD, PhD, MMS
role: PRINCIPAL_INVESTIGATOR
References: