Major Depressive DisorderPhase 4UB ECTNCT00870805
Ultrabrief Pulsewidth Electroconvulsive Therapy (ECT)
A Phase 4 study testing bilateral ultrabrief ECT, bilateral standard ECT and right-unilateral ultrabrief ECT in people with Major Depressive Disorder, run by The University of New South Wales at 3 sites in Australia.
Trial summary
Electroconvulsive Therapy (ECT) remains essential to contemporary psychiatric practice and is one of the safest and most effective treatments available for depression. Despite modern advances in pharmacotherapy, about 15-20 per cent of all hospitalised patients receive treatment with ECT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- bilateral ultrabrief ECT, bilateral standard ECT and right-unilateral ultrabrief ECT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesAustralia
- Study dates
- Jan 2009to Jan 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meet criteria for a DSM-IV-TR Major Depressive Episode
- Total MADRS score >/= 25
- Age >/= 18 years
- Educated or working in an English medium setting
Who cannot join
- Diagnosis (as defined by DSM-IV-TR) of any psychotic disorder (lifetime with exception of Major Depressive Episode with psychotic features); rapid cycling bipolar disorder, eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year).
- history of drug or alcohol abuse or dependence (as per DSM-IV-TR) in the last 6 months (except nicotine and caffeine).
- ECT in last 3 months
- Subject requires an urgent clinical response due to inanition, psychosis or high suicide risk
- unable to give informed consent
- score < 24 on Mini Mental State Examination
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
St George Hospital
Kogarah, New South Wales, 2217
Wandene Private Hospital
Kogarah, New South Wales, 2217
The Melbourne Clinic
Melbourne, Victoria
About this study
Official title: A Controlled Study of Ultrabrief Pulsewidth ECT (Electroconvulsive Therapy)
Electroconvulsive Therapy (ECT) remains essential to contemporary psychiatric practice and is one of the safest and most effective treatments available for depression. Despite modern advances in pharmacotherapy, about 15-20 per cent of all hospitalised patients receive treatment with ECT. Its use, however, is limited by concerns over associated cognitive side effects.
Recent research has suggested that using an ultrabrief pulsewidth with ECT may greatly reduce cognitive side effects, while maintaining efficacy (Sackeim et al 2008). Preliminary results were positive for unilateral ECT, however, suggest that for bilateral ECT, dosing may need to be adjusted to preserve efficacy while reducing side effects. This study will examine the relative cognitive side effects and efficacy of right unilateral and bilateral ECT given with a standard pulsewidth or an ultrabrief pulsewidth. Some participants will also receive an MRI scan before and after ECT.
- Conditions
- Major Depressive Disorder
- Being tested
- bilateral ultrabrief ECT, bilateral standard ECT, right-unilateral ultrabrief ECT, right-unilateral standard ECT
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral ultrabrief ECTProcedure or surgery
Bilateral ECT at 3-4 times seizure threshold with an ultrabrief pulse (0.3ms)
bilateral standard ECTProcedure or surgery
Bilateral ECT with at 1.5 times seizure threshold with a standard pulse (1.0ms)
right-unilateral ultrabrief ECTProcedure or surgery
Right-unilateral ECT at 6 times seizure threshold with an ultrabrief pulse (0.3ms)
right-unilateral standard ECTProcedure or surgery
Right-unilateral ECT with at 5 times seizure threshold with a standard pulse (1.0ms)
| Study group | Role | What they receive |
|---|---|---|
| bilateral-ultrabrief ECT | Experimental | Patients will be treated with an ultrabrief (0.3ms) pulse with a bilateral placement at 3-4 times seizure threshold. Receives: Procedure: bilateral ultrabrief ECT |
| bilateral standard ECT | Active comparator | Patients will be treated with a standard (1.0ms) pulse with a bilateral placement at 1.5 times seizure threshold. Receives: Procedure: bilateral standard ECT |
| right-unilateral ultrabrief ECT | Experimental | Patients will be treated with an ultrabrief (0.3ms) pulse with a right unilateral placement at 8 times seizure threshold. Receives: Procedure: right-unilateral ultrabrief ECT |
| right-unilateral standard ECT | Active comparator | Patients will be treated with a standard (1.0ms) pulse with a right unilateral placement at 5 times seizure threshold. Receives: Procedure: right-unilateral standard ECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores on Memory Tests
Measured: Before ECT, after 6 ECT treatments, after final ECT treatment, one month and six month follow-up
Secondary outcomes (1)
Change in scores on Depression Rating Scale
Measured: Before ECT, after each week of treatment, at the end of the ECT course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Major Depressive 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- Northside Clinic, Australia, The Melbourne Clinic, Australia, St George Hospital, Australia, Wandene Private Hospital, Australia
- Investigators
- Assoc/Prof Colleen K Loo, MBBS, FRANZCP, MD, Principal investigator, University of New South WalesProf Isaac Schweitzer, MBBS, FRANZCP, MD, Principal investigator, The Melbourne Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870805
- Sponsor's protocol ID
- UNSW HREC 08322
- Acronym
- UB ECT
- Status last verified
- Sep 2011
- First submitted
- 26 Mar 2009
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Loo CK, Schweitzer I, Pratt C. Recent advances in optimizing electroconvulsive therapy. Aust N Z J Psychiatry. 2006 Aug;40(8):632-8. doi: 10.1080/j.1440-1614.2006.01862.x.
PubMed 16866758Loo C, Sheehan P, Pigot M, Lyndon W. A report on mood and cognitive outcomes with right unilateral ultrabrief pulsewidth (0.3 ms) ECT and retrospective comparison with standard pulsewidth right unilateral ECT. J Affect Disord. 2007 Nov;103(1-3):277-81. doi: 10.1016/j.jad.2007.06.012. Epub 2007 Aug 16.
PubMed 17706790Loo CK, Sainsbury K, Sheehan P, Lyndon B. A comparison of RUL ultrabrief pulse (0.3 ms) ECT and standard RUL ECT. Int J Neuropsychopharmacol. 2008 Nov;11(7):883-90. doi: 10.1017/S1461145708009292. Epub 2008 Aug 28.
PubMed 18752719Sackeim HA, Prudic J, Nobler MS, Fitzsimons L, Lisanby SH, Payne N, Berman RM, Brakemeier EL, Perera T, Devanand DP. Effects of pulse width and electrode placement on the efficacy and cognitive effects of electroconvulsive therapy. Brain Stimul. 2008 Apr;1(2):71-83. doi: 10.1016/j.brs.2008.03.001.
PubMed 19756236Sienaert, P., Vansteelandt, K., Demyttenaere, K., & Peuskens, J. (2006). Comparison of bifrontal and unilateral ultra-brief pulse electroconvulsive therapy for depression. European Neuropsychopharmacology, 16 (suppl 4), S28.
Martin D, Katalinic N, Hadzi-Pavlovic D, Ingram A, Ingram N, Simpson B, McGoldrick J, Dowling N, Loo C. Cognitive effects of brief and ultrabrief pulse bitemporal electroconvulsive therapy: a randomised controlled proof-of-concept trial. Psychol Med. 2020 May;50(7):1121-1128. doi: 10.1017/S0033291719000989. Epub 2019 May 2.
PubMed 31056081Loo CK, Katalinic N, Smith DJ, Ingram A, Dowling N, Martin D, Addison K, Hadzi-Pavlovic D, Simpson B, Schweitzer I. A randomized controlled trial of brief and ultrabrief pulse right unilateral electroconvulsive therapy. Int J Neuropsychopharmacol. 2014 Dec 5;18(1):pyu045. doi: 10.1093/ijnp/pyu045.
PubMed 25522389
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Study of Ultrabrief Pulsewidth ECT (Electroconvulsive Therapy)
- ClinicalTrials.gov ID
- NCT00870805
- Acronym / sponsor ID
- UB ECT / UNSW HREC 08322
- Conditions
- Major Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- Northside Clinic, Australia, The Melbourne Clinic, Australia, St George Hospital, Australia, Wandene Private Hospital, Australia
- Study start
- Jan 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 27 Mar 2009 (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.
Electroconvulsive Therapy (ECT) remains essential to contemporary psychiatric practice and is one of the safest and most effective treatments available for depression. Despite modern advances in pharmacotherapy, about 15-20 per cent of all hospitalised patients receive treatment with ECT. Its use, however, is limited by concerns over associated cognitive side effects.
Recent research has suggested that using an ultrabrief pulsewidth with ECT may greatly reduce cognitive side effects, while maintaining efficacy (Sackeim et al 2008). Preliminary results were positive for unilateral ECT, however, suggest that for bilateral ECT, dosing may need to be adjusted to preserve efficacy while reducing side effects. This study will examine the relative cognitive side effects and efficacy of right unilateral and bilateral ECT given with a standard pulsewidth or an ultrabrief pulsewidth. Some participants will also receive an MRI scan before and after ECT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| bilateral-ultrabrief ECT | Experimental | Procedure: bilateral ultrabrief ECTPatients will be treated with an ultrabrief (0.3ms) pulse with a bilateral placement at 3-4 times seizure threshold. |
| bilateral standard ECT | Active comparator | Procedure: bilateral standard ECTPatients will be treated with a standard (1.0ms) pulse with a bilateral placement at 1.5 times seizure threshold. |
| right-unilateral ultrabrief ECT | Experimental | Procedure: right-unilateral ultrabrief ECTPatients will be treated with an ultrabrief (0.3ms) pulse with a right unilateral placement at 8 times seizure threshold. |
| right-unilateral standard ECT | Active comparator | Procedure: right-unilateral standard ECTPatients will be treated with a standard (1.0ms) pulse with a right unilateral placement at 5 times seizure threshold. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects meet criteria for a DSM-IV-TR Major Depressive Episode
- Total MADRS score >/= 25
- Age >/= 18 years
- Educated or working in an English medium setting
Key exclusion criteria (6 listed)
- Diagnosis (as defined by DSM-IV-TR) of any psychotic disorder (lifetime with exception of Major Depressive Episode with psychotic features); rapid cycling bipolar disorder, eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year).
- history of drug or alcohol abuse or dependence (as per DSM-IV-TR) in the last 6 months (except nicotine and caffeine).
- ECT in last 3 months
- Subject requires an urgent clinical response due to inanition, psychosis or high suicide risk
- unable to give informed consent
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 |
|---|---|---|
| bilateral ultrabrief ECTBilateral ECT at 3-4 times seizure threshold with an ultrabrief pulse (0.3ms) | Procedure or surgery | bilateral-ultrabrief ECT |
| bilateral standard ECTBilateral ECT with at 1.5 times seizure threshold with a standard pulse (1.0ms) | Procedure or surgery | bilateral standard ECT |
| right-unilateral ultrabrief ECTRight-unilateral ECT at 6 times seizure threshold with an ultrabrief pulse (0.3ms) | Procedure or surgery | right-unilateral ultrabrief ECT |
| right-unilateral standard ECTRight-unilateral ECT with at 5 times seizure threshold with a standard pulse (1.0ms) | Procedure or surgery | right-unilateral standard ECT |
Primary outcome
Change in scores on Memory Tests
Time frame: Before ECT, after 6 ECT treatments, after final ECT treatment, one month and six month follow-up
1 secondary outcome
Change in scores on Depression Rating Scale
Time frame: Before ECT, after each week of treatment, at the end of the ECT course
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 27 Feb 2013.
- Background: PubMed 16866758Loo CK, Schweitzer I, Pratt C. Recent advances in optimizing electroconvulsive therapy. Aust N Z J Psychiatry. 2006 Aug;40(8):632-8. doi: 10.1080/j.1440-1614.2006.01862.x.
- Background: PubMed 17706790Loo C, Sheehan P, Pigot M, Lyndon W. A report on mood and cognitive outcomes with right unilateral ultrabrief pulsewidth (0.3 ms) ECT and retrospective comparison with standard pulsewidth right unilateral ECT. J Affect Disord. 2007 Nov;103(1-3):277-81. doi: 10.1016/j.jad.2007.06.012. Epub 2007 Aug 16.
- Background: PubMed 18752719Loo CK, Sainsbury K, Sheehan P, Lyndon B. A comparison of RUL ultrabrief pulse (0.3 ms) ECT and standard RUL ECT. Int J Neuropsychopharmacol. 2008 Nov;11(7):883-90. doi: 10.1017/S1461145708009292. Epub 2008 Aug 28.
- Background: PubMed 19756236Sackeim HA, Prudic J, Nobler MS, Fitzsimons L, Lisanby SH, Payne N, Berman RM, Brakemeier EL, Perera T, Devanand DP. Effects of pulse width and electrode placement on the efficacy and cognitive effects of electroconvulsive therapy. Brain Stimul. 2008 Apr;1(2):71-83. doi: 10.1016/j.brs.2008.03.001.
- BackgroundSienaert, P., Vansteelandt, K., Demyttenaere, K., & Peuskens, J. (2006). Comparison of bifrontal and unilateral ultra-brief pulse electroconvulsive therapy for depression. European Neuropsychopharmacology, 16 (suppl 4), S28.
- Derived from this study: PubMed 31056081Martin D, Katalinic N, Hadzi-Pavlovic D, Ingram A, Ingram N, Simpson B, McGoldrick J, Dowling N, Loo C. Cognitive effects of brief and ultrabrief pulse bitemporal electroconvulsive therapy: a randomised controlled proof-of-concept trial. Psychol Med. 2020 May;50(7):1121-1128. doi: 10.1017/S0033291719000989. Epub 2019 May 2.
- Derived from this study: PubMed 25522389Loo CK, Katalinic N, Smith DJ, Ingram A, Dowling N, Martin D, Addison K, Hadzi-Pavlovic D, Simpson B, Schweitzer I. A randomized controlled trial of brief and ultrabrief pulse right unilateral electroconvulsive therapy. Int J Neuropsychopharmacol. 2014 Dec 5;18(1):pyu045. doi: 10.1093/ijnp/pyu045.
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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.
Assoc/Prof Colleen K Loo, MBBS, FRANZCP, MD principal investigator
University of New South Wales
Prof Isaac Schweitzer, MBBS, FRANZCP, MD principal investigator
The Melbourne Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bilateral ultrabrief ECT, bilateral standard ECT and right-unilateral ultrabrief ECT in people with Major Depressive Disorder, run by The University of New South Wales at 3 sites in Australia.
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 6 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 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in scores on Memory Tests (time frame: Before ECT, after 6 ECT treatments, after final ECT treatment, one month and six month follow-up). 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 NCT00870805, which also lists 7 linked publications.
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 27 Feb 2013.