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

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ClinicalTrials.gov Identifier: NCT00739856
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : August 22, 2008
Sponsor:
Collaborator:
Government Psychiatric Diseases Hospital, Srinagar
Information provided by:
Government Medical College Srinagar

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Procedure: Electroconvulsive Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of ECT in Chronic, Severe, Antidepressant- And CBT-Refractory Posttraumatic Stress Disorder: An Open, Prospective Study
Study Start Date : January 2005
Actual Primary Completion Date : December 2005

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Clinician-Administered Posttraumatic Stress Disorder Scale (CAPS) SCORE

Secondary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale score [ Time Frame: baseline, 48 hrs post 3rd, 6th ECT ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: August 22, 2008
Last Verified: August 2008

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
Trauma and Stressor Related Disorders
Mental Disorders