NCT01723033

Brief Summary

Comparison of the neurophysiological response of OCD and PTSD patients (both considered anxiety syndromes) in error processing. The patients will perform three computerized tasks while a net of electrodes (for EEG measurement) will be placed on their head. This data will then be compared to a previously collected healthy control sample.

Trial Health

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Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

November 8, 2012

Status Verified

November 1, 2012

Enrollment Period

1 year

First QC Date

November 5, 2012

Last Update Submit

November 7, 2012

Conditions

Keywords

PTSDOCD

Outcome Measures

Primary Outcomes (1)

  • Yale Brown Obsessive Compulsive Scale (Y-BOCS)

Secondary Outcomes (1)

  • Montgomery Asberg Depression Rating Scale (MADRAS)

Other Outcomes (1)

  • Clinician rating scale for assessing current and lifetime PTSD (CAPS)

Study Arms (2)

EEG acquisition

15 PTSD patients and 15 OCD patients who will, while wearing a net of electrodes for EEG acquisition on their heads, perform three error detection tasks.

Control

Previously collected healthy student's data

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from the outpatient clinic of the Beersheva Mental Health Center. 15 OCT and 15 PTSD patients

You may qualify if:

  • Diagnosis of PTSD or OCD by DSM-IV criteria;
  • For OCD subjects a Y-BOCS score larger than 16 composted form both obsession and compulsion patient's responses;
  • For PTSD population a CAPS score larger than 40.
  • Either no medicated patients or a combination of anti-anxiety, anti-depressant and tranquilizers.
  • Patients with minimum depression symptoms (MDRAS \< 18)

You may not qualify if:

  • A medical history of other major psychiatric disorder.
  • A known ailment of the central nervous system.
  • No history of loss of consciousness.
  • No history of head injury or abnormal head trauma upon routine imaging.
  • No anti-psychotic or anti-epileptic and tricyclic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Doron Todder, MD

    Beersheva Mental Health Center and Ben Gurion University of the Negev

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 7, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Last Updated

November 8, 2012

Record last verified: 2012-11