Posttraumatic Stress DisorderPhase 2NCT01664260
Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder
A Phase 2 study testing N-acetylcysteine in people with Posttraumatic Stress Disorder, run by Ewha Womans University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- N-acetylcysteine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2012to 31 Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-65 year-old male or female
- Posttraumatic stress disorder diagnosed by SCID-IV
- Written informed consent
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- N-acetylcysteine, Placebo
- Keywords
- Posttraumatic Stress Disorder, N-acetylcysteine, Magnetic Resonance Imaging
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
0 - 8 week: 10 mg escitalopram a day + 1200 mg N-acetylcysteine twice a day
PlaceboDrug
0 - 8 week: 10 mg escitalopram a day + 1200 mg Placebo twice a day
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine + Escitalopram | Experimental | The subjects with posttraumatic stress disorder, treated with N-acetylcysteine in addition to escitalopram Receives: Drug: N-acetylcysteine |
| Placebo + Escitalopram | Placebo comparator | The subjects with posttraumatic stress disorder, treated with placebo in addition to escitalopram Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach
Measured: Baseline, 8th weeks
Change from baseline in Clinician-administered PTSD scale scores at 4th weeks
Measured: Baseline, 4th weeks
Change from baseline in Clinician-administered PTSD scale scores at 8th weeks
Measured: Baseline, 8th weeks
Secondary outcomes (6)
Change from baseline in Hamilton depression rating scale scores at 4th weeks
Measured: Baseline, 4th weeks
Change from baseline in Hamilton depression rating scale scores at 8th weeks
Measured: Baseline, 8th weeks
Change from baseline in Hamilton anxiety rating scale scores at 4th weeks
Measured: Baseline, 4th weeks
Change from baseline in Hamilton anxiety rating scale scores at 8th weeks
Measured: Baseline, 8th weeks
Number of participants with adverse events
Measured: 4th weeks
Number of participants with adverse events
Measured: 8th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study start1 Nov 2012 (estimated)
- Primary completion1 Dec 2016 (estimated)
- Study completion31 Dec 2016 (estimated)
Why it stopped: The research project has been cancelled before any participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Kyoon Lyoo, Ewha Womans University
- Investigators
- Inkyoon Lyoo, MD, PhD, MMS, Principal investigator, Ewha Womans University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664260
- Sponsor's protocol ID
- iklnac
- Status last verified
- Feb 2018
- First submitted
- 10 Aug 2012
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidation of Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder: An 8-week Multimodal Neuroimaging and Neurocognitive Study
- ClinicalTrials.gov ID
- NCT01664260
- Acronym / sponsor ID
- iklnac
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, N-acetylcysteine, Magnetic Resonance Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The research project has been cancelled before any participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- 1 Nov 2012 (estimated)
- Primary completion
- 1 Dec 2016 (estimated)
- Study completion
- 31 Dec 2016 (estimated)
- First posted
- 14 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine + Escitalopram | Experimental | Drug: N-acetylcysteineThe subjects with posttraumatic stress disorder, treated with N-acetylcysteine in addition to escitalopram |
| Placebo + Escitalopram | Placebo comparator | Drug: PlaceboThe subjects with posttraumatic stress disorder, treated with placebo in addition to escitalopram |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20-65 year-old male or female
- Posttraumatic stress disorder diagnosed by SCID-IV
- Written informed consent
Key exclusion criteria (12 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteine0 - 8 week: 10 mg escitalopram a day + 1200 mg N-acetylcysteine twice a day | Drug | N-acetylcysteine + Escitalopram |
| Placebo0 - 8 week: 10 mg escitalopram a day + 1200 mg Placebo twice a day | Drug | Placebo + Escitalopram |
Primary outcome
Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach
Time frame: Baseline, 8th weeks
Change from baseline in Clinician-administered PTSD scale scores at 4th weeks
Time frame: Baseline, 4th weeks
Change from baseline in Clinician-administered PTSD scale scores at 8th weeks
Time frame: Baseline, 8th weeks
6 secondary outcomes
Change from baseline in Hamilton depression rating scale scores at 4th weeks
Time frame: Baseline, 4th weeks
Change from baseline in Hamilton depression rating scale scores at 8th weeks
Time frame: Baseline, 8th weeks
Change from baseline in Hamilton anxiety rating scale scores at 4th weeks
Time frame: Baseline, 4th weeks
Change from baseline in Hamilton anxiety rating scale scores at 8th weeks
Time frame: Baseline, 8th weeks
Number of participants with adverse events
Time frame: 4th weeks
Number of participants with adverse events
Time frame: 8th weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inkyoon Lyoo, MD, PhD, MMS principal investigator
Ewha Womans University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-acetylcysteine in people with Posttraumatic Stress Disorder, run by Ewha Womans University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach (time frame: Baseline, 8th weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.