NCT00739856

Brief Summary

Post Traumatic Stress Disorder is a chronic debilitating illness and few treatment options have demonstrated effectiveness. The study will look at the use of electroconvulsive therapy for the treatment of Post Traumatic Stress disorder in patients who have not responded to multiple antidepressants or cognitive behavioral therapy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2008

Completed
Last Updated

August 22, 2008

Status Verified

August 1, 2008

Enrollment Period

11 months

First QC Date

August 20, 2008

Last Update Submit

August 21, 2008

Conditions

Posttraumatic Stress Disorder

Keywords

posttraumatic stress disorderelectroconvulsive therapymedication refractoriness

Outcome Measures

Primary Outcomes (1)

  • Clinician-Administered Posttraumatic Stress Disorder Scale (CAPS) SCORE

Secondary Outcomes (1)

  • Montgomery-Asberg Depression Rating Scale score

    baseline, 48 hrs post 3rd, 6th ECT

Interventions

Electroconvulsive TherapyPROCEDURE

ECT was administered using the MECTA-SR1 apparatus. The current amplitude was 800 mA, pulse width was 1.5 ms, and pulse frequency was 50 Hz. Stimulus duration was increased as required to elicit an adequate seizure, defined as at least 25 s with EEG monitoring. The ECT course was fixed, and comprised 6 treatments administered with bitemporal electrode placement at a twice-weekly frequency

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of PTSD
  • Treatment resistance to 4 different antidepressants from 3 different classes
  • Treatment resistance to CBT
  • Severe PTSD

You may not qualify if:

  • Significant substance abuse
  • Pregnancy
  • History of Traumatic Brain Injury
  • Unstable comorbid medical illness
  • Organic brain syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Government Hospital for Psychiatric Disease

Srinagar, Jammu and Kashmir, 190003, India

Location

Related Publications (1)

  • Margoob MA, Ali Z, Andrade C. Efficacy of ECT in chronic, severe, antidepressant- and CBT-refractory PTSD: an open, prospective study. Brain Stimul. 2010 Jan;3(1):28-35. doi: 10.1016/j.brs.2009.04.005. Epub 2009 May 27.

    PMID: 20633428DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Electroconvulsive Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Convulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Mushtaq Margoob, MD

    Government Medical College Srinagar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 22, 2008

Study Start

January 1, 2005

Primary Completion

December 1, 2005

Last Updated

August 22, 2008

Record last verified: 2008-08

Locations

IN(1)