Bipolar DisorderNCT00664976
Treatment Resistant Depression in Bipolar Disorder - A Randomized Controlled Trial of Electroconvulsive Therapy
A study testing Electroconvulsive therapy and Treatment as usual in people with Bipolar Disorder, run by Norwegian University of Science and Technology at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Electroconvulsive therapy and Treatment as usual
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesNorway
- Study dates
- Apr 2008to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland University Hospital
Bergen, 5000
St Olavs Hospital, Østmarka sykehus
Trondheim
About this study
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.
Read 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 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.
- Conditions
- Bipolar Disorder
- Being tested
- Electroconvulsive therapy, Treatment as usual
- Keywords
- bipolar depression, Electroconvulsive therapy
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive therapyProcedure or surgery
Electroconvulsive therapy
Treatment as usualOther
Pharmacological antidepressant as usual in the departments: Mood stabilizers as Lithium, lamotrigine, valproate, quetiapine, carbamazepine and olanzapine. Antidepressants + Psychosocial treatment as usual.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Electroconvulsive therapy Receives: Procedure: Electroconvulsive therapy |
| 2 | Active comparator | Treatment as usual Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in depression
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2011
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Vest
- Responsible party
- Sponsor
- Investigators
- Arne Vaaler, MD PhD, Study director, NTNU; Helse Vest RHF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664976
- Sponsor's protocol ID
- ECT-0408
- Status last verified
- Jan 2017
- First submitted
- 14 Apr 2008
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Schoeyen HK, Kessler U, Andreassen OA, Auestad BH, Bergsholm P, Malt UF, Morken G, Oedegaard KJ, Vaaler A. Treatment-resistant bipolar depression: a randomized controlled trial of electroconvulsive therapy versus algorithm-based pharmacological treatment. Am J Psychiatry. 2015 Jan;172(1):41-51. doi: 10.1176/appi.ajp.2014.13111517. Epub 2014 Oct 31.
PubMed 25219389Bjoerke-Bertheussen J, Schoeyen H, Andreassen OA, Malt UF, Oedegaard KJ, Morken G, Sundet K, Vaaler AE, Auestad B, Kessler U. Right unilateral electroconvulsive therapy does not cause more cognitive impairment than pharmacologic treatment in treatment-resistant bipolar depression: A 6-month randomized controlled trial follow-up study. Bipolar Disord. 2018 Sep;20(6):531-538. doi: 10.1111/bdi.12594. Epub 2017 Dec 21.
PubMed 29267990Kessler U, Schoeyen HK, Andreassen OA, Eide GE, Malt UF, Oedegaard KJ, Morken G, Sundet K, Vaaler AE. The effect of electroconvulsive therapy on neurocognitive function in treatment-resistant bipolar disorder depression. J Clin Psychiatry. 2014 Nov;75(11):e1306-13. doi: 10.4088/JCP.13m08960.
PubMed 25470096Kessler U, Schoeyen HK, Andreassen OA, Eide GE, Hammar A, Malt UF, Oedegaard KJ, Morken G, Sundet K, Vaaler AE. Neurocognitive profiles in treatment-resistant bipolar I and bipolar II disorder depression. BMC Psychiatry. 2013 Apr 4;13:105. doi: 10.1186/1471-244X-13-105.
PubMed 23557429Kessler U, Vaaler AE, Schoyen H, Oedegaard KJ, Bergsholm P, Andreassen OA, Malt UF, Morken G. The study protocol of the Norwegian randomized controlled trial of electroconvulsive therapy in treatment resistant depression in bipolar disorder. BMC Psychiatry. 2010 Feb 23;10:16. doi: 10.1186/1471-244X-10-16.
PubMed 20178636
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Resistant Depression in Bipolar Disorder - A Randomized Controlled Trial of Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT00664976
- Acronym / sponsor ID
- ECT-0408
- Conditions
- Bipolar Disorder
- Keywords
- bipolar depression, Electroconvulsive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Helse Vest
- Study start
- Apr 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 23 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Electroconvulsive therapyElectroconvulsive therapy |
| 2 | Active comparator | Other: Treatment as usualTreatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroconvulsive therapyElectroconvulsive therapy | Procedure or surgery | 1 |
| Treatment as usualPharmacological antidepressant as usual in the departments: Mood stabilizers as Lithium, lamotrigine, valproate, quetiapine, carbamazepine and olanzapine. Antidepressants + Psychosocial treatment as usual. | Other | 2 |
Primary outcome
Improvement in depression
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Results publication: PubMed 25219389Schoeyen HK, Kessler U, Andreassen OA, Auestad BH, Bergsholm P, Malt UF, Morken G, Oedegaard KJ, Vaaler A. Treatment-resistant bipolar depression: a randomized controlled trial of electroconvulsive therapy versus algorithm-based pharmacological treatment. Am J Psychiatry. 2015 Jan;172(1):41-51. doi: 10.1176/appi.ajp.2014.13111517. Epub 2014 Oct 31.
- Derived from this study: PubMed 29267990Bjoerke-Bertheussen J, Schoeyen H, Andreassen OA, Malt UF, Oedegaard KJ, Morken G, Sundet K, Vaaler AE, Auestad B, Kessler U. Right unilateral electroconvulsive therapy does not cause more cognitive impairment than pharmacologic treatment in treatment-resistant bipolar depression: A 6-month randomized controlled trial follow-up study. Bipolar Disord. 2018 Sep;20(6):531-538. doi: 10.1111/bdi.12594. Epub 2017 Dec 21.
- Derived from this study: PubMed 25470096Kessler U, Schoeyen HK, Andreassen OA, Eide GE, Malt UF, Oedegaard KJ, Morken G, Sundet K, Vaaler AE. The effect of electroconvulsive therapy on neurocognitive function in treatment-resistant bipolar disorder depression. J Clin Psychiatry. 2014 Nov;75(11):e1306-13. doi: 10.4088/JCP.13m08960.
- Derived from this study: PubMed 23557429Kessler U, Schoeyen HK, Andreassen OA, Eide GE, Hammar A, Malt UF, Oedegaard KJ, Morken G, Sundet K, Vaaler AE. Neurocognitive profiles in treatment-resistant bipolar I and bipolar II disorder depression. BMC Psychiatry. 2013 Apr 4;13:105. doi: 10.1186/1471-244X-13-105.
- Derived from this study: PubMed 20178636Kessler U, Vaaler AE, Schoyen H, Oedegaard KJ, Bergsholm P, Andreassen OA, Malt UF, Morken G. The study protocol of the Norwegian randomized controlled trial of electroconvulsive therapy in treatment resistant depression in bipolar disorder. BMC Psychiatry. 2010 Feb 23;10:16. doi: 10.1186/1471-244X-10-16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Vaaler, MD PhD study director
NTNU; Helse Vest RHF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroconvulsive therapy and Treatment as usual in people with Bipolar Disorder, run by Norwegian University of Science and Technology at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in depression (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00664976, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.