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

January 15, 2017 updated by: Norwegian University of Science and Technology
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Treatment as usual
Other: Treatment as usual
Pharmacological antidepressant as usual in the departments: Mood stabilizers as Lithium, lamotrigine, valproate, quetiapine, carbamazepine and olanzapine. Antidepressants + Psychosocial treatment as usual.
Experimental: 1
Electroconvulsive therapy
Procedure: Electroconvulsive therapy
Electroconvulsive therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in depression
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

Helse Vest

Investigators

  • Study Director: Arne Vaaler, MD PhD, NTNU; Helse Vest RHF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

April 14, 2008

First Submitted That Met QC Criteria

April 22, 2008

First Posted (Estimate)

April 23, 2008

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 15, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECT-0408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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