Treatment Resistant Depression in Bipolar Disorder - A Randomized Controlled Trial of Electroconvulsive Therapy
Information source: Norwegian University of Science and Technology
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Treatment Resistant Bipolar Depression
Intervention: Electroconvulsive therapy (Procedure); Treatment as usual (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: Norwegian University of Science and Technology Overall contact:
Gunnar Morken, MD PhD, Phone: 47-73-864-609, Email: gunnar.morken@ntnu.no
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.
Clinical Details
Official title: Treatment Resistant Depression in Bipolar Disorder - A Randomized Controlled Trial of Electroconvulsive Therapy
Study design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Improvement in depression
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 we 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. We 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 fundet by Helse
Vest RHF, Regional research network on mood disorders (MoodNet) and Norwegian hospitals.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 30 or above and sum
of MADRS items 2,7,8 and 9 of 12 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 psychotrophic 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
Locations and Contacts
Gunnar Morken, MD PhD, Phone: 47-73-864-609, Email: gunnar.morken@ntnu.no
Haukeland University Hospital, Bergen 5000, Norway; Not yet recruiting
Ute Kessler, MD, Email: ute.kessler@helse-bergen.no
Ute Kessler, MD, Principal Investigator
Haukeland University Hospital, Bergen 5000, Norway; Recruiting
Ute Kessler, MD, Phone: +4755974575, Email: ute.kessler@helse-bergen.no
Ute Kessler, MD, Principal Investigator
Additional Information
Starting date: April 2008
Ending date: April 2013
Last updated: April 27, 2009
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