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

This study has been completed.
Sponsor:
Collaborator:
Government Psychiatric Diseases Hospital, Srinagar
Information provided by:
Government Medical College Srinagar
ClinicalTrials.gov Identifier:
NCT00739856
First received: August 20, 2008
Last updated: August 21, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Posttraumatic Stress Disorder
Procedure: Electroconvulsive Therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of ECT in Chronic, Severe, Antidepressant- And CBT-Refractory Posttraumatic Stress Disorder: An Open, Prospective Study

Resource links provided by NLM:


Further study details as provided by Government Medical College Srinagar:

Primary Outcome Measures:
  • Clinician-Administered Posttraumatic Stress Disorder Scale (CAPS) SCORE [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale score [ Time Frame: baseline, 48 hrs post 3rd, 6th ECT ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Electroconvulsive Therapy
    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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739856

Locations
India
Government Hospital for Psychiatric Disease
Srinagar, Jammu & Kashmir, India, 190003
Sponsors and Collaborators
Government Medical College Srinagar
Government Psychiatric Diseases Hospital, Srinagar
Investigators
Principal Investigator: Mushtaq Margoob, MD Government Medical College Srinagar
  More Information

No publications provided by Government Medical College Srinagar

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00739856     History of Changes
Other Study ID Numbers: GMCPTSD_ECT2005
Study First Received: August 20, 2008
Last Updated: August 21, 2008
Health Authority: India: Indian Council of Medical Research

Keywords provided by Government Medical College Srinagar:
posttraumatic stress disorder
electroconvulsive therapy
medication refractoriness

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014