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

This study has been completed.
Sponsor:
Collaborator:
Helse Vest
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00664976
First received: April 14, 2008
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Bipolar Disorder
Procedure: Electroconvulsive therapy
Other: Treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Treatment Resistant Depression in Bipolar Disorder - A Randomized Controlled Trial of Electroconvulsive Therapy

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Improvement in depression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: April 2008
Study Completion Date: September 2013
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Electroconvulsive therapy
Procedure: Electroconvulsive therapy
Electroconvulsive therapy
Other Name: Electroconvulsive therapy
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664976

Locations
Norway
Haukeland University Hospital
Bergen, Norway, 5000
St Olavs Hospital, Østmarka sykehus
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
Helse Vest
Investigators
Study Director: Arne Vaaler, MD PhD NTNU; Helse Vest RHF
  More Information

No publications provided by Norwegian University of Science and Technology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00664976     History of Changes
Other Study ID Numbers: ECT-0408
Study First Received: April 14, 2008
Last Updated: September 16, 2013
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Norwegian University of Science and Technology:
bipolar depression
Electroconvulsive therapy

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 28, 2014