Ultrabrief Pulsewidth Electroconvulsive Therapy (ECT)

Major Depressive Disorder Clinical Trial

— UB ECT  

Official title:

A Controlled Study of Ultrabrief Pulsewidth ECT (Electroconvulsive Therapy)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870805
• Other study ID #: UNSW HREC 08322
• Status: Completed
• Phase: Phase 4
• First received: March 26, 2009
• Last updated: February 26, 2013
• Start date: January 2009
• Est. completion date: January 2013

Study information

• Verified date: September 2011
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: National Health and Medical Research Council
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Procedure:
• bilateral ultrabrief ECT
Bilateral ECT at 3-4 times seizure threshold with an ultrabrief pulse (0.3ms)
• bilateral standard ECT
Bilateral ECT with at 1.5 times seizure threshold with a standard pulse (1.0ms)
• right-unilateral ultrabrief ECT
Right-unilateral ECT at 6 times seizure threshold with an ultrabrief pulse (0.3ms)
• right-unilateral standard ECT
Right-unilateral ECT with at 5 times seizure threshold with a standard pulse (1.0ms)

Locations

Country	Name	City	State
Australia	St George Hospital	Kogarah	New South Wales
Australia	Wandene Private Hospital	Kogarah	New South Wales
Australia	The Melbourne Clinic	Melbourne	Victoria

Sponsors (5)

Lead Sponsor	Collaborator
The University of New South Wales	Northside Clinic, Australia, St George Hospital, Australia, The Melbourne Clinic, Australia, Wandene Private Hospital, Australia

Country where clinical trial is conducted

Australia, 

References & Publications (5)

Loo 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. Epub 2007 Aug 16. — View Citation

Loo 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. — View Citation

Loo CK, Schweitzer I, Pratt C. Recent advances in optimizing electroconvulsive therapy. Aust N Z J Psychiatry. 2006 Aug;40(8):632-8. Review. — View Citation

Sackeim 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. Erratum in: Brain Stimul. 2008 Jul;1(3):A2. — View Citation

Sienaert, 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in scores on Memory Tests		Before ECT, after 6 ECT treatments, after final ECT treatment, one month and six month follow-up	No
Secondary	Change in scores on Depression Rating Scale		Before ECT, after each week of treatment, at the end of the ECT course	No