Posttraumatic Stress Disorder
Conditions
Keywords
Posttraumatic Stress Disorder, N-acetylcysteine, Magnetic Resonance Imaging
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.
Interventions
DRUGN-acetylcysteine
0 - 8 week: 10 mg escitalopram a day + 1200 mg N-acetylcysteine twice a day
DRUGPlacebo
0 - 8 week: 10 mg escitalopram a day + 1200 mg Placebo twice a day
Sponsors
Ewha Womans University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach | Baseline, 8th weeks |
| Change from baseline in Clinician-administered PTSD scale scores at 4th weeks | Baseline, 4th weeks |
| Change from baseline in Clinician-administered PTSD scale scores at 8th weeks | Baseline, 8th weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Hamilton anxiety rating scale scores at 8th weeks | Baseline, 8th weeks |
| Change from baseline in Hamilton depression rating scale scores at 4th weeks | Baseline, 4th weeks |
| Number of participants with adverse events | 4th weeks |
| Change from baseline in Hamilton depression rating scale scores at 8th weeks | Baseline, 8th weeks |
| Change from baseline in Hamilton anxiety rating scale scores at 4th weeks | Baseline, 4th weeks |
Countries
South Korea
Outcome results
None listed