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Major DepressionPhase 4NCT01559324

Electroconvulsive Therapy (ECT) for Elderly Patients With Major Depression

A Phase 4 study testing ECT in people with Major Depression, run by Diakonhjemmet Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

ECT (electroconvulsive therapy) is mostly given to patients between the age of 60 - 85 years. There is limited evidence on the efficacy and cognitive side-effects of right unilateral (RU) and bifrontal (BF) electrode positions, the placements that are considered safe for the elderly. Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Major Depression
What is being tested?
ECT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteNorway
Study dates
Aug 2009to Nov 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 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Major depression, either unipolar or bipolar.
  • Competent to give informed consent.
  • Passing a thorough physical examination

Who cannot join

  • Previous ECT non - response
  • ECT given during last 6 months
  • Ongoing substance abuse
  • Rapid cycling bipolar or schizoaffective disorder
  • Parkinsons disease
  • Cognitive impairment (MMSE < 24/30)

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Diakonhjemmet Hospital, Department of Old Age Psychiatry

    Oslo, 0854

Other trials in Norway

About this study

Official title: Randomized Controlled Comparison of Bifrontal and Right Unilateral ECT as to Effects on Depression, Global Cognitive Function and Biomarkers.

ECT (electroconvulsive therapy) is mostly given to patients between the age of 60 - 85 years. There is limited evidence on the efficacy and cognitive side-effects of right unilateral (RU) and bifrontal (BF) electrode positions, the placements that are considered safe for the elderly. As far as the investigators know no randomized controlled trials (RCTs) have yet been published describing this population treated with BF or RU ECT. Non-demented depressed patients will be randomized to either method (n = 2x36). Symptom intensity, global cognitive function and biomarkers will be related to 20 healthy comparators. Testing, evaluation of depression and blood-tests are done before ECT-treatment, after a series of 6-16 ECT and 3 months after terminated ECT-treatment.

Read the detailed description

Patients are assessed with Mini Mental Status Examination. Postictal reorientation time is measured. There is also a weekly rating of depression depth during the series. After the 6th ECT; Mini Mental Status Examination For a subgroup of patients; extensive blood-test samples are taken on the day of the 6th ECT.

Some of the patients receive continuation-ECT once monthly after the series. In these months patients receive treatment as usual (naturalistic observation).

Being tested
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.

  • ECTDevice

    Bifrontal ECT, low dosage

  • ECTDevice

    Right unilateral electrode position, high dosage

Study groups in NCT01559324
Study groupRoleWhat they receive
Bifrontal ECT (BF)ExperimentalFormula-based low dose BF ECT
Receives: Device: ECT
Right unilateral ECT (RU)ExperimentalFormula-based high-dose RU ECT
Receives: Device: ECT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depression

    Hamilton depression Scale 17 items (HAM-D-17), Montgomery Åsberg Depression Rating Scale (MADRS)

    Measured: 5 months

Secondary outcomes (2)

  1. Cognitive function

    Measured: 5 months

  2. Blood-tests

    Cytokines, complement factors, BDNF, S-100-beta among others

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2012 (estimated)
  2. Study startAug 2009
  3. Primary completionJul 2013
  4. Study completionNov 2013

Resources

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
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01559324
Sponsor's protocol ID
6.2009.06 2011/02/0009
Status last verified
Jul 2015
First submitted
19 Mar 2012
Last updated
9 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • van der Wurff FB, Stek ML, Hoogendijk WJ, Beekman AT. The efficacy and safety of ECT in depressed older adults: a literature review. Int J Geriatr Psychiatry. 2003 Oct;18(10):894-904. doi: 10.1002/gps.944.

    PubMed 14533122

  • Tielkes CE, Comijs HC, Verwijk E, Stek ML. The effects of ECT on cognitive functioning in the elderly: a review. Int J Geriatr Psychiatry. 2008 Aug;23(8):789-95. doi: 10.1002/gps.1989.

    PubMed 18311845

  • Gardner BK, O'Connor DW. A review of the cognitive effects of electroconvulsive therapy in older adults. J ECT. 2008 Mar;24(1):68-80. doi: 10.1097/YCT.0b013e318165c7b0.

    PubMed 18379338

  • Kellner CH, Tobias KG, Wiegand J. Electrode placement in electroconvulsive therapy (ECT): A review of the literature. J ECT. 2010 Sep;26(3):175-80. doi: 10.1097/YCT.0b013e3181e48154.

    PubMed 20562639

  • Kellner CH, Knapp R, Husain MM, Rasmussen K, Sampson S, Cullum M, McClintock SM, Tobias KG, Martino C, Mueller M, Bailine SH, Fink M, Petrides G. Bifrontal, bitemporal and right unilateral electrode placement in ECT: randomised trial. Br J Psychiatry. 2010 Mar;196(3):226-34. doi: 10.1192/bjp.bp.109.066183.

    PubMed 20194546

  • Gaarden TL, Engedal K, Benth JS, Larsen M, Lorentzen B, Mollnes TE, Bjolseth TM, Castellheim A. Exploration of 27 plasma immune markers: a cross-sectional comparison of 64 old psychiatric inpatients having unipolar major depression and 18 non-depressed old persons. BMC Geriatr. 2018 Jun 25;18(1):149. doi: 10.1186/s12877-018-0836-x.

    PubMed 29940870

  • Bjolseth TM, Engedal K, Benth JS, Dybedal GS, Gaarden TL, Tanum L. Clinical efficacy of formula-based bifrontal versus right unilateral electroconvulsive therapy (ECT) in the treatment of major depression among elderly patients: a pragmatic, randomized, assessor-blinded, controlled trial. J Affect Disord. 2015 Apr 1;175:8-17. doi: 10.1016/j.jad.2014.12.054. Epub 2014 Dec 31.

    PubMed 25590761

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ECT in people with Major Depression, run by Diakonhjemmet Hospital at 1 site in Norway.

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 3 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 9 Jul 2015. 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 Norway. 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?

Depression (time frame: 5 months). 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 NCT01559324, 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 9 Jul 2015.

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