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CompletedNCT00664976Updated Jan 18, 2017

Treatment Resistant Depression in Bipolar Disorder - A Randomized Controlled Trial of Electroconvulsive Therapy

An interventional study of Electroconvulsive therapy and Treatment as usual in Bipolar Disorder, sponsored by Norwegian University of Science and Technology. Completed at 2 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-18.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

This project is a randomized controlled trial of electroconvulsive therapy (ECT) compared to treatment as usual (TAU) in the treatment of treatment resistant depression (TRD) in bipolar disorder. The purpose of the trial is to document the effect size, relative effect size and adverse effects of ECT in this condition. A specific purpose is to gain more knowledge about the effect on cognitive function.

Read the detailed description

This project is a randomized controlled trial of electroconvulsive therapy (ECT) compared to treatment as usual (TAU) in the treatment of treatment resistant depression (TRD) in bipolar disorder. The purpose of the trial is to document the effect size, relative effect size and adverse effects of ECT in this condition. A specific purpose is to gain more knowledge about the effect on cognitive function.

In a national collaboration project the investigators will compare the antidepressant and cognitive effects of ECT with the effects of a drug treatment in use for this condition; a treatment algorithm combining antidepressants, mood stabilizer and antipsychotic drugs. The investigators will use a neuropsychological test battery to disclose possible ECT induced changes in cognitive function, and investigate any long-lasting changes.

In addition, several studies have implemented inflammatory processes in the pathogenesis of depression; inflammatory processes will be examined as a function of changes in clinical status and of treatment modality.

The study is a national collaboration, using the Bipolar Research And Innovation Network- BRAIN, and all the patients are included in the BRAIN-study. The study is funded by Helse Vest RHF, Regional research network on mood disorders (MoodNet) and Norwegian hospitals.

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Conditions studied

  • Bipolar Disorder

Keywords

  • bipolar depression
  • Electroconvulsive therapy
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 73 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ECT indicated
  • Diagnosis of DSM-IV-TR of Bipolar I or Bipolar II disorder as verified by the semi-structured diagnostic interviews SCID or MINI plus.
  • Severity: meet DSM-IV-TR criteria of depressive episode, MADRS of 25 or above.
  • Treatment resistance
  • None response to two trials (during lifetime) with mood stabilizer with proven efficacy in bipolar depression (lithium, lamotrigine, quetiapine, olanzapine) and /or antidepressants.
  • A trial is defined as at least 6 weeks in adequate or tolerated dose as reported by the patient, or patients that have been unable to comply with 6 weeks trials of mood stabilizer or an antidepressant.
  • Less than 50% reduction in MADRS values or still meet DSM -IV-TR criteria of depressive episode
  • Inpatients the first week after start of treatment condition
  • The patient are to be treated by the psychiatrist at the hospital for the whole duration of the study (6 weeks)
  • Age ≥ 18
  • Patient competent to give informed consent according to the judgement of the clinician
  • Written informed consent
  • Patient fluent in Norwegian language

Exclusion criteria

Exclusion Criteria:

  • Earlier ECT nonresponse
  • ECT within the last six months
  • More than four failed adequate medication trials in the current episode
  • Rapid cycling bipolar disorder (e.g.4 or more episodes per year)
  • Use of medication or substances (such as pethidine, alcohol, drugs) incompatible with drug medication or ECT. Such medication must be stopped a least 5 half-lives before inclusion in the study.
  • Current use of all other psychotropic medication 5 t1/2 before inclusion and during the study period with the exception of the following:
  • The use of alimemazine (max dose 30 mg daily), chlorpromazine (max dose 25 mg x 2 daily) and chlorprotixen (max dose 20 mg x 2) is allowed. The use of mianserin (max dose 10 mg daily) is allowed. Such medication has to been discontinued at least 2 days prior neuropsychological assessment. Medication related to the ECT procedure is allowed.
  • Inability to comply with study protocol
  • Unstable serious medical conditions, including clinically relevant laboratory abnormalities
  • Conditions that affect neuropsychological assessment such as Parkinson's Disease, Multiple sclerosis, stroke, alcohol and substance abuse or dependence (according to SCID or DSM-IV-TR)
  • Pregnancy or lactation
  • Fertile women without adequate contraception (Adequate contraception includes: abstinence, oral contraceptives, intrauterine devices, barrier method)
  • YMRS of 20 or more
  • Patient at high suicidal risk according to clinicians' judgment
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
73 participants (actual)

Study arms

  • Experimental
    1

    Electroconvulsive therapy

    Procedure: Electroconvulsive therapy

  • Active comparator
    2

    Treatment as usual

    Other: Treatment as usual

Interventions

  • ProcedureElectroconvulsive therapy

    Electroconvulsive therapy

  • OtherTreatment as usual

    Pharmacological antidepressant as usual in the departments: Mood stabilizers as Lithium, lamotrigine, valproate, quetiapine, carbamazepine and olanzapine. Antidepressants + Psychosocial treatment as usual.

06

What researchers measure

Primary outcomes

  1. Improvement in depression

    Time frame: 6 weeks

07

Study locations

2 sites
  • Haukeland University Hospital
    Bergen, 5000, Norway
  • St Olavs Hospital, Østmarka sykehus
    Trondheim, Norway
08

References and documents

Publications

  • Schoeyen HK, Kessler U, Andreassen OA, Auestad BH, Bergsholm P, Malt UF, Morken G, Oedegaard KJ, Vaaler A. Treatment-resistant bipolar depression: a randomized controlled trial of electroconvulsive therapy versus algorithm-based pharmacological treatment. Am J Psychiatry. 2015 Jan;172(1):41-51. doi: 10.1176/appi.ajp.2014.13111517. Epub 2014 Oct 31. PubMed 25219389 ↗
  • Bjoerke-Bertheussen J, Schoeyen H, Andreassen OA, Malt UF, Oedegaard KJ, Morken G, Sundet K, Vaaler AE, Auestad B, Kessler U. Right unilateral electroconvulsive therapy does not cause more cognitive impairment than pharmacologic treatment in treatment-resistant bipolar depression: A 6-month randomized controlled trial follow-up study. Bipolar Disord. 2018 Sep;20(6):531-538. doi: 10.1111/bdi.12594. Epub 2017 Dec 21. PubMed 29267990 ↗
  • Kessler U, Schoeyen HK, Andreassen OA, Eide GE, Malt UF, Oedegaard KJ, Morken G, Sundet K, Vaaler AE. The effect of electroconvulsive therapy on neurocognitive function in treatment-resistant bipolar disorder depression. J Clin Psychiatry. 2014 Nov;75(11):e1306-13. doi: 10.4088/JCP.13m08960. PubMed 25470096 ↗
  • Kessler U, Schoeyen HK, Andreassen OA, Eide GE, Hammar A, Malt UF, Oedegaard KJ, Morken G, Sundet K, Vaaler AE. Neurocognitive profiles in treatment-resistant bipolar I and bipolar II disorder depression. BMC Psychiatry. 2013 Apr 4;13:105. doi: 10.1186/1471-244X-13-105. PubMed 23557429 ↗
  • Kessler U, Vaaler AE, Schoyen H, Oedegaard KJ, Bergsholm P, Andreassen OA, Malt UF, Morken G. The study protocol of the Norwegian randomized controlled trial of electroconvulsive therapy in treatment resistant depression in bipolar disorder. BMC Psychiatry. 2010 Feb 23;10:16. doi: 10.1186/1471-244X-10-16. PubMed 20178636 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00664976
Lead sponsor
Norwegian University of Science and Technology
Collaborators
Helse Vest
Responsible party
Sponsor
First posted
Apr 23, 2008
Start date
Apr 2008
Primary completion
May 2011
Completion
Sep 2013
Last update
Jan 18, 2017

Study contacts

Arne Vaaler, MD PhD
study director · NTNU; Helse Vest RHF

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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