- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00739856
Use of Electroconvulsive Therapy (ECT) in Chronic, Severe, Treatment Resistant Posttraumatic Stress Disorder
August 21, 2008 updated by: Government Medical College Srinagar
Efficacy of ECT in Chronic, Severe, Antidepressant- And CBT-Refractory Posttraumatic Stress Disorder: An Open, Prospective Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jammu & Kashmir
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Srinagar, Jammu & Kashmir, India, 190003
- Government Hospital for Psychiatric Disease
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Clinician-Administered Posttraumatic Stress Disorder Scale (CAPS) SCORE
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Montgomery-Asberg Depression Rating Scale score
Time Frame: baseline, 48 hrs post 3rd, 6th ECT
|
baseline, 48 hrs post 3rd, 6th ECT
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mushtaq Margoob, MD, Government Medical College Srinagar
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
August 20, 2008
First Submitted That Met QC Criteria
August 21, 2008
First Posted (Estimate)
August 22, 2008
Study Record Updates
Last Update Posted (Estimate)
August 22, 2008
Last Update Submitted That Met QC Criteria
August 21, 2008
Last Verified
August 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GMCPTSD_ECT2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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