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Depressive Disorder, MajorPhase 4NCT00627887

Randomised Controlled Trial of Electroconvulsive Therapy (ECT) in Relapse Prevention of Depression

A Phase 4 study testing Electroconvulsive therapy, venlafaxine and Lithium in people with Depressive Disorder, Major, run by Örebro County Council at 4 sites in Sweden.

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

The purpose of the study is to determine if continuation electroconvulsive therapy (ECT) is safe and effective in relapse prevention of depression. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depressive Disorder, Major
What is being tested?
Electroconvulsive therapy, venlafaxine and Lithium
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
4 sitesSweden
Study dates
Jan 2008to May 2012
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

  • MINI-PLUS verified major depressive episode (unipolar or bipolar).
  • ECT within the last 3 weeks.
  • Either Remission defined as MADRS < 10 or
  • Response defined as MADRS < 15 combined with patient assessed CGI-I of at least much improved

Who cannot join

  • Schizophrenia or Schizoaffective disorder
  • Addiction or Dependence
  • Kidney disease that contraindicates lithium treatment
  • Vascular or heart disease that contraindicates venlafaxine treatment
  • Uncontrolled Epilepsia
  • Age less that 18
  • Pregnancy or Lactation

Trial locations and contacts

4 sites in 1 country.

Sweden4 sites

  • Psychiatric clinic

    Örebro, Örebro County, 70116

  • Psychiatric Clinic

    Säter, Dalarna County, 78327

  • Löwenströmska sjukhuset

    Stockholm, Stockholm County, 11000

  • Psychiatric Clinic

    Uppsala, Uppsala County, 75017

Other trials in Sweden

About this study

Official title: Randomised Controlled Trial of Electroconvulsive Therapy (ECT) With Pharmacotherapy or Pharmacotherapy Alone in Relapse Prevention of Depression

The purpose of the study is to determine if continuation electroconvulsive therapy (ECT) is safe and effective in relapse prevention of depression.

Read the detailed description

Randomized multicenter clinical trial with two parallel groups. Patients with major depression (unipolar or bipolar), who have remitted with electroconvulsive therapy (ECT) are eligible. All patients receive pharmacotherapy (venlafaxine target dose 300mg/day, and lithium target dose 0,5-0,8 mmol/L). The intervention is continuation unilateral ECT weekly for the first 6 weeks thereafter every 2 weeks for one year. Depressive relapse is the primary outcome measure.

Being tested
Electroconvulsive therapy, venlafaxine, Lithium
Keywords
Depressive Disorder, Major, Electroconvulsive Therapy, Lithium Carbonate, venlafaxine
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.

  • Electroconvulsive therapyProcedure or surgery

    Also called ECT

    unilateral briefpulse ECT weekly for the first 6 weeks thereafter every 2 weeks for a total of one year

  • venlafaxineDrug

    Also called Efexor, Effexor

    extended release target dose of 300mg/day duration of one year

  • LithiumDrug

    Also called Lithionit, Lithobid, Eskalith

    serum concentration 0,5-0,8 mmol/L, one year duration

Study groups in NCT00627887
Study groupRoleWhat they receive
ECT+pharmacotherapyExperimentalUnilateral brief pulse ECT weekly for 6 weeks thereafter every 2 weeks; Venlafaxine target dose 300mg/day; Lithium target dose 0,5-0,8 mmol/L.
Receives: Procedure: Electroconvulsive therapy; Drug: venlafaxine; Drug: Lithium
pharmacotherapyActive comparatorVenlafaxine target dose 300mg/day; Lithium 0,5-0,8 mmol/L.
Receives: Drug: venlafaxine; Drug: Lithium

What is being measured

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

  1. MADRS >20, psychiatric hospitalization or suicide

    Measured: 1 year, all patients assessed if MADRS-S > 20 and at 2,6 and 12 months

Secondary outcomes (6)

  1. Mini Mental State Examination

    Measured: 2,6 and 12 months

  2. ADAS-cog

    Measured: 2,6 and 12 months

  3. Autobiographical Memory Inventory -Short Form (AMI-SF)

    Measured: 2,6 and 12 months patients treated in Örebro

  4. Clinical Global Impression-Severity

    Measured: 2,6 and 12 months

  5. Udvalg for Kliniske Undersogelser (UKU)

    Measured: 2, 6 and 12 months

  6. MADRS-S Montgomery Asberg Depression Rating scale- self assessment

    Measured: weekly for 6 weeks thereafter every 2 weeks for a total of one year

Timeline

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

  1. First posted4 Mar 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionMay 2012
  4. Study completionMay 2012

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
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00627887
Sponsor's protocol ID
ISRCTN40355220
Other IDs
ISRCTN40355220
Status last verified
Jun 2012
First submitted
4 Jan 2008
Last updated
22 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • Kellner CH, Knapp RG, Petrides G, Rummans TA, Husain MM, Rasmussen K, Mueller M, Bernstein HJ, O'Connor K, Smith G, Biggs M, Bailine SH, Malur C, Yim E, McClintock S, Sampson S, Fink M. Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE). Arch Gen Psychiatry. 2006 Dec;63(12):1337-44. doi: 10.1001/archpsyc.63.12.1337.

    PubMed 17146008

  • Sackeim HA, Haskett RF, Mulsant BH, Thase ME, Mann JJ, Pettinati HM, Greenberg RM, Crowe RR, Cooper TB, Prudic J. Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a randomized controlled trial. JAMA. 2001 Mar 14;285(10):1299-307. doi: 10.1001/jama.285.10.1299.

    PubMed 11255384

  • Brus O, Cao Y, Carlborg A, Engstrom I, von Knorring L, Nordenskjold A. Long-Term Effect of Maintenance Electroconvulsive Therapy in Patients With Depression-Data From a Small Randomized Controlled Trial. J ECT. 2024 Sep 1;40(3):169-172. doi: 10.1097/YCT.0000000000000983. Epub 2023 Dec 28.

    PubMed 38232249

  • Nordenskjold A, von Knorring L, Ljung T, Carlborg A, Brus O, Engstrom I. Continuation electroconvulsive therapy with pharmacotherapy versus pharmacotherapy alone for prevention of relapse of depression: a randomized controlled trial. J ECT. 2013 Jun;29(2):86-92. doi: 10.1097/YCT.0b013e318276591f.

    PubMed 23303421

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Electroconvulsive therapy, venlafaxine and Lithium in people with Depressive Disorder, Major, run by Örebro County Council at 4 sites in Sweden.

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 7 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 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Sweden. 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?

MADRS >20, psychiatric hospitalization or suicide (time frame: 1 year, all patients assessed if MADRS-S > 20 and at 2,6 and 12 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 NCT00627887, which also lists 4 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 22 Jun 2012.

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