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

Posttraumatic Stress Disorder Clinical Trial

Official title:

Efficacy of ECT in Chronic, Severe, Antidepressant- And CBT-Refractory Posttraumatic Stress Disorder: An Open, Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739856
• Other study ID #: GMCPTSD_ECT2005
• Status: Completed
• Phase: N/A
• First received: August 20, 2008
• Last updated: August 21, 2008
• Start date: January 2005

Study information

• Verified date: August 2008
• Source: Government Medical College Srinagar
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
India	Government Hospital for Psychiatric Disease	Srinagar	Jammu & Kashmir

Sponsors (2)

Lead Sponsor	Collaborator
Government Medical College Srinagar	Government Psychiatric Diseases Hospital, Srinagar

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician-Administered Posttraumatic Stress Disorder Scale (CAPS) SCORE			No
Secondary	Montgomery-Asberg Depression Rating Scale score		baseline, 48 hrs post 3rd, 6th ECT	No