Use of Electroconvulsive Therapy (ECT) in Chronic, Severe, Treatment Resistant Posttraumatic Stress Disorder
This study has been completed.
Sponsor:
Government Medical College Srinagar
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 20, 2008 | ||||
| Last Updated Date | August 21, 2008 | ||||
| Start Date ICMJE | January 2005 | ||||
| Primary Completion Date | December 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Clinician-Administered Posttraumatic Stress Disorder Scale (CAPS) SCORE [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00739856 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Montgomery-Asberg Depression Rating Scale score [ Time Frame: baseline, 48 hrs post 3rd, 6th ECT ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Use of Electroconvulsive Therapy (ECT) in Chronic, Severe, Treatment Resistant Posttraumatic Stress Disorder | ||||
| Official Title ICMJE | Efficacy of ECT in Chronic, Severe, Antidepressant- And CBT-Refractory Posttraumatic Stress Disorder: An Open, Prospective Study | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Posttraumatic Stress Disorder | ||||
| Intervention ICMJE | 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 |
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| Study Arm (s) | Not Provided | ||||
| Publications * | 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. Epub 2009 May 27. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | December 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | India | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00739856 | ||||
| Other Study ID Numbers ICMJE | GMCPTSD_ECT2005 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Government Medical College Srinagar | ||||
| Collaborators ICMJE | Government Psychiatric Diseases Hospital, Srinagar | ||||
| Investigators ICMJE |
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| Information Provided By | Government Medical College Srinagar | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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