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

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Electroconvulsive therapy
Treatment as usual
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring bipolar depression, Electroconvulsive therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Haukeland University Hospital
  • St Olavs Hospital, Østmarka sykehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Electroconvulsive therapy

Treatment as usual

Outcomes

Primary Outcome Measures

Improvement in depression

Secondary Outcome Measures

Full Information

First Posted
April 14, 2008
Last Updated
January 15, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Vest
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1. Study Identification

Unique Protocol Identification Number
NCT00664976
Brief Title
Treatment Resistant Depression in Bipolar Disorder - A Randomized Controlled Trial of Electroconvulsive Therapy
Official Title
Treatment Resistant Depression in Bipolar Disorder - A Randomized Controlled Trial of Electroconvulsive Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Vest

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
bipolar depression, Electroconvulsive therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Electroconvulsive therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Treatment as usual
Intervention Type
Procedure
Intervention Name(s)
Electroconvulsive therapy
Intervention Description
Electroconvulsive therapy
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Pharmacological antidepressant as usual in the departments: Mood stabilizers as Lithium, lamotrigine, valproate, quetiapine, carbamazepine and olanzapine. Antidepressants + Psychosocial treatment as usual.
Primary Outcome Measure Information:
Title
Improvement in depression
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Vaaler, MD PhD
Organizational Affiliation
NTNU; Helse Vest RHF
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5000
Country
Norway
Facility Name
St Olavs Hospital, Østmarka sykehus
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
25219389
Citation
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.
Results Reference
result
PubMed Identifier
29267990
Citation
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.
Results Reference
derived
PubMed Identifier
25470096
Citation
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.
Results Reference
derived
PubMed Identifier
23557429
Citation
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.
Results Reference
derived
PubMed Identifier
20178636
Citation
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.
Results Reference
derived

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

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