Status:
COMPLETED
Treatment Resistant Depression in Bipolar Disorder - A Randomized Controlled Trial of Electroconvulsive Therapy
Lead Sponsor:
Norwegian University of Science and Technology
Collaborating Sponsors:
Helse Vest
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00664976
Start Date
April 1 2008
End Date
September 1 2013
Last Update
January 18 2017
Active Locations (2)
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1
Haukeland University Hospital
Bergen, Norway, 5000
2
St Olavs Hospital, Østmarka sykehus
Trondheim, Norway