ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01664260
Recruitment Status : Withdrawn (The research project has been cancelled before any participants were enrolled.)
First Posted : August 14, 2012
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
In Kyoon Lyoo, Ewha Womans University

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.


Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Drug: N-acetylcysteine Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Elucidation of Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder: An 8-week Multimodal Neuroimaging and Neurocognitive Study
Estimated Study Start Date : November 1, 2012
Estimated Primary Completion Date : December 1, 2016
Estimated Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: N-acetylcysteine + Escitalopram
The subjects with posttraumatic stress disorder, treated with N-acetylcysteine in addition to escitalopram
Drug: N-acetylcysteine
0 - 8 week: 10 mg escitalopram a day + 1200 mg N-acetylcysteine twice a day
Placebo Comparator: Placebo + Escitalopram
The subjects with posttraumatic stress disorder, treated with placebo in addition to escitalopram
Drug: Placebo
0 - 8 week: 10 mg escitalopram a day + 1200 mg Placebo twice a day



Primary Outcome Measures :
  1. Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach [ Time Frame: Baseline, 8th weeks ]
  2. Change from baseline in Clinician-administered PTSD scale scores at 4th weeks [ Time Frame: Baseline, 4th weeks ]
  3. Change from baseline in Clinician-administered PTSD scale scores at 8th weeks [ Time Frame: Baseline, 8th weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Hamilton depression rating scale scores at 4th weeks [ Time Frame: Baseline, 4th weeks ]
  2. Change from baseline in Hamilton depression rating scale scores at 8th weeks [ Time Frame: Baseline, 8th weeks ]
  3. Change from baseline in Hamilton anxiety rating scale scores at 4th weeks [ Time Frame: Baseline, 4th weeks ]
  4. Change from baseline in Hamilton anxiety rating scale scores at 8th weeks [ Time Frame: Baseline, 8th weeks ]
  5. Number of participants with adverse events [ Time Frame: 4th weeks ]
  6. Number of participants with adverse events [ Time Frame: 8th weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01664260


Locations
Korea, Republic of
Ewha Womans University Medical Center
Seoul, Korea, Republic of, 158-710
Sponsors and Collaborators
Ewha Womans University
Investigators
Principal Investigator: Inkyoon Lyoo, MD, PhD, MMS Ewha Womans University

Responsible Party: In Kyoon Lyoo, Professor, Ewha Womans University
ClinicalTrials.gov Identifier: NCT01664260     History of Changes
Other Study ID Numbers: iklnac
First Posted: August 14, 2012    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Keywords provided by In Kyoon Lyoo, Ewha Womans University:
Posttraumatic Stress Disorder
N-acetylcysteine
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Citalopram
Dexetimide
Acetylcysteine
N-monoacetylcystine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Antiviral Agents
Anti-Infective Agents