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The research project has been cancelled before any participants were enrolled.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-acetylcysteine + Escitalopram | Experimental | The subjects with posttraumatic stress disorder, treated with N-acetylcysteine in addition to escitalopram |
|
| Placebo + Escitalopram | Placebo Comparator | The subjects with posttraumatic stress disorder, treated with placebo in addition to escitalopram |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine | Drug | 0 - 8 week: 10 mg escitalopram a day + 1200 mg N-acetylcysteine twice a day |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Hamilton depression rating scale scores at 4th weeks | Baseline, 4th weeks | |
| Change from baseline in Hamilton depression rating scale scores at 8th weeks | Baseline, 8th weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Inkyoon Lyoo, MD, PhD, MMS | Ewha Womans University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewha Womans University Medical Center | Seoul | 158-710 | South Korea |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | 0 - 8 week: 10 mg escitalopram a day + 1200 mg Placebo twice a day |
|
| Change from baseline in Hamilton anxiety rating scale scores at 4th weeks | Baseline, 4th weeks |
| Change from baseline in Hamilton anxiety rating scale scores at 8th weeks | Baseline, 8th weeks |
| Number of participants with adverse events | 4th weeks |
| Number of participants with adverse events | 8th weeks |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |