Posttraumatic Stress DisorderNCT00739856
Use of Electroconvulsive Therapy (ECT) in Chronic, Severe, Treatment Resistant Posttraumatic Stress Disorder
A study testing Electroconvulsive Therapy in people with Posttraumatic Stress Disorder, run by Government Medical College Srinagar at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Electroconvulsive Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2005to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PTSD
- Treatment resistance to 4 different antidepressants from 3 different classes
- Treatment resistance to CBT
- Severe PTSD
Who cannot join
- Significant substance abuse
- Pregnancy
- History of Traumatic Brain Injury
- Unstable comorbid medical illness
- Organic brain syndrome
Trial locations and contacts
1 site in 1 country.
India1 site
Government Hospital for Psychiatric Disease
Srinagar, Jammu and Kashmir, 190003
About this study
Official title: 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Electroconvulsive Therapy
- Keywords
- posttraumatic stress disorder, electroconvulsive therapy, medication refractoriness
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive TherapyProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered Posttraumatic Stress Disorder Scale (CAPS) SCORE
Secondary outcomes (1)
Montgomery-Asberg Depression Rating Scale score
Measured: baseline, 48 hrs post 3rd, 6th ECT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startJan 2005
- Primary completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Medical College Srinagar
- Sponsor type
- Other government
- Collaborators
- Government Psychiatric Diseases Hospital, Srinagar
- Investigators
- Mushtaq Margoob, MD, Principal investigator, Government Medical College Srinagar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739856
- Sponsor's protocol ID
- GMCPTSD_ECT2005
- Status last verified
- Aug 2008
- First submitted
- 20 Aug 2008
- Last updated
- 22 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/j.brs.2009.04.005. Epub 2009 May 27.
PubMed 20633428
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of ECT in Chronic, Severe, Antidepressant- And CBT-Refractory Posttraumatic Stress Disorder: An Open, Prospective Study
- ClinicalTrials.gov ID
- NCT00739856
- Acronym / sponsor ID
- GMCPTSD_ECT2005
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- posttraumatic stress disorder, electroconvulsive therapy, medication refractoriness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Government Medical College SrinagarOther government
- Collaborators
- Government Psychiatric Diseases Hospital, Srinagar
- Study start
- Jan 2005
- Primary completion
- Dec 2005 (actual)
- First posted
- 22 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of PTSD
- Treatment resistance to 4 different antidepressants from 3 different classes
- Treatment resistance to CBT
- Severe PTSD
Key exclusion criteria (5 listed)
- Significant substance abuse
- Pregnancy
- History of Traumatic Brain Injury
- Unstable comorbid medical illness
- Organic brain syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroconvulsive TherapyECT 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 | Procedure or surgery | – |
Primary outcome
Clinician-Administered Posttraumatic Stress Disorder Scale (CAPS) SCORE
1 secondary outcome
Montgomery-Asberg Depression Rating Scale score
Time frame: baseline, 48 hrs post 3rd, 6th ECT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2008.
- Derived from this study: PubMed 20633428Margoob 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. doi: 10.1016/j.brs.2009.04.005. Epub 2009 May 27.
Related trials for Posttraumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mushtaq Margoob, MD principal investigator
Government Medical College Srinagar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroconvulsive Therapy in people with Posttraumatic Stress Disorder, run by Government Medical College Srinagar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered Posttraumatic Stress Disorder Scale (CAPS) SCORE. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00739856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2008.