NCT01664260

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

4.1 years

First QC Date

August 10, 2012

Last Update Submit

February 8, 2018

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress DisorderN-acetylcysteineMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • 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

  • 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

  • +1 more secondary outcomes

Study Arms (2)

N-acetylcysteine + Escitalopram

EXPERIMENTAL

The subjects with posttraumatic stress disorder, treated with N-acetylcysteine in addition to escitalopram

Drug: N-acetylcysteine

Placebo + Escitalopram

PLACEBO COMPARATOR

The subjects with posttraumatic stress disorder, treated with placebo in addition to escitalopram

Drug: Placebo

Interventions

N-acetylcysteineDRUG

0 - 8 week: 10 mg escitalopram a day + 1200 mg N-acetylcysteine twice a day

N-acetylcysteine + Escitalopram
PlaceboDRUG

0 - 8 week: 10 mg escitalopram a day + 1200 mg Placebo twice a day

Placebo + Escitalopram

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year-old male or female
  • Posttraumatic stress disorder diagnosed by SCID-IV
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha Womans University Medical Center

Seoul, 158-710, South Korea

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Inkyoon Lyoo, MD, PhD, MMS

    Ewha Womans University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 10, 2012

First Posted

August 14, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 31, 2016

Last Updated

February 9, 2018

Record last verified: 2018-02

Locations

KR(1)