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Use of Electroconvulsive Therapy (ECT) in Chronic, Severe, Treatment Resistant Posttraumatic Stress Disorder

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Electroconvulsive Therapy
Sponsored by
Government Medical College Srinagar
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring posttraumatic stress disorder, electroconvulsive therapy, medication refractoriness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Government Hospital for Psychiatric Disease

Outcomes

Primary Outcome Measures

Clinician-Administered Posttraumatic Stress Disorder Scale (CAPS) SCORE

Secondary Outcome Measures

Montgomery-Asberg Depression Rating Scale score

Full Information

First Posted
August 20, 2008
Last Updated
August 21, 2008
Sponsor
Government Medical College Srinagar
Collaborators
Government Psychiatric Diseases Hospital, Srinagar
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1. Study Identification

Unique Protocol Identification Number
NCT00739856
Brief Title
Use of Electroconvulsive Therapy (ECT) in Chronic, Severe, Treatment Resistant Posttraumatic Stress Disorder
Official Title
Efficacy of ECT in Chronic, Severe, Antidepressant- And CBT-Refractory Posttraumatic Stress Disorder: An Open, Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Government Medical College Srinagar
Collaborators
Government Psychiatric Diseases Hospital, Srinagar

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
posttraumatic stress disorder, electroconvulsive therapy, medication refractoriness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Electroconvulsive Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinician-Administered Posttraumatic Stress Disorder Scale (CAPS) SCORE
Secondary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale score
Time Frame
baseline, 48 hrs post 3rd, 6th ECT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of PTSD Treatment resistance to 4 different antidepressants from 3 different classes Treatment resistance to CBT Severe PTSD Exclusion Criteria: Significant substance abuse Pregnancy History of Traumatic Brain Injury Unstable comorbid medical illness Organic brain syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mushtaq Margoob, MD
Organizational Affiliation
Government Medical College Srinagar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Government Hospital for Psychiatric Disease
City
Srinagar
State/Province
Jammu & Kashmir
ZIP/Postal Code
190003
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
20633428
Citation
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.
Results Reference
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Use of Electroconvulsive Therapy (ECT) in Chronic, Severe, Treatment Resistant Posttraumatic Stress Disorder

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