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

Sponsors and Collaborators:	Norwegian University of Science and Technology Helse Vest RHF
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00664976

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	Phase
Treatment Resistant Bipolar Depression	Procedure: Electroconvulsive therapy Other: Treatment as usual	Phase IV

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Divalproex sodium Valproate Sodium Valproic acid Quetiapine Quetiapine fumarate Olanzapine Lamotrigine Carbamazepine Lithium carbonate Lithium citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Treatment Resistant Depression in Bipolar Disorder - A Randomized Controlled Trial of Electroconvulsive Therapy

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 ]

Estimated Enrollment:	132
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Electroconvulsive therapy	Procedure: Electroconvulsive therapy Electroconvulsive therapy
2: Active Comparator 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 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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

Contacts

Contact: Gunnar Morken, MD PhD	47-73-864-609	gunnar.morken@ntnu.no
Contact: Ute Kessler, MD		ute.kessler@helse-bergen.no

Locations

Norway
Haukeland University Hospital
Bergen, Norway, 5000

Sponsors and Collaborators

Norwegian University of Science and Technology

Helse Vest RHF

More Information

Responsible Party:	Helse Vest RHF ( MD PhD Gunnar Morken, Associated Professor )
Study ID Numbers:	ECT-0408
Study First Received:	April 14, 2008
Last Updated:	April 22, 2008
ClinicalTrials.gov Identifier:	NCT00664976
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by Norwegian University of Science and Technology:

bipolar depression ect

Study placed in the following topic categories:

Depression
Bipolar Disorder
Olanzapine
Lithium Carbonate
Depressive Disorder
Valproic Acid
Behavioral Symptoms
Affective Disorders, Psychotic

Quetiapine
Carbamazepine
Mental Disorders
Mood Disorders
Lamotrigine
Psychotic Disorders
Lithium

ClinicalTrials.gov processed this record on January 16, 2009