NCT00664976

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

3.1 years

First QC Date

April 14, 2008

Last Update Submit

January 15, 2017

Conditions

Bipolar Disorder

Keywords

bipolar depressionElectroconvulsive therapy

Outcome Measures

Primary Outcomes (1)

  • Improvement in depression

    6 weeks

Study Arms (2)

1

EXPERIMENTAL

Electroconvulsive therapy

Procedure: Electroconvulsive therapy

2

ACTIVE COMPARATOR

Treatment as usual

Other: Treatment as usual

Interventions

Electroconvulsive therapyPROCEDURE

Electroconvulsive therapy

1
Treatment as usualOTHER

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haukeland University Hospital

Bergen, 5000, Norway

Location

St Olavs Hospital, Østmarka sykehus

Trondheim, Norway

Location

Related Publications (5)

  • 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.

    PMID: 25219389RESULT

  • 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.

    PMID: 29267990DERIVED

  • 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.

    PMID: 25470096DERIVED

  • 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.

    PMID: 23557429DERIVED

  • 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.

    PMID: 20178636DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Electroconvulsive TherapyTherapeutics

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Convulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Arne Vaaler, MD PhD

    NTNU; Helse Vest RHF

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2008

First Posted

April 23, 2008

Study Start

April 1, 2008

Primary Completion

May 1, 2011

Study Completion

September 1, 2013

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

NO(2)