Depressive Disorder, MajorPhase 4NCT00627887
Randomised Controlled Trial of Electroconvulsive Therapy (ECT) in Relapse Prevention of Depression
A Phase 4 study testing Electroconvulsive therapy, venlafaxine and Lithium in people with Depressive Disorder, Major, run by Örebro County Council at 4 sites in Sweden.
Trial summary
The purpose of the study is to determine if continuation electroconvulsive therapy (ECT) is safe and effective in relapse prevention of depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Electroconvulsive therapy, venlafaxine and Lithium
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 4 sitesSweden
- Study dates
- Jan 2008to May 2012
- Phase
- Phase 4
- 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
- MINI-PLUS verified major depressive episode (unipolar or bipolar).
- ECT within the last 3 weeks.
- Either Remission defined as MADRS < 10 or
- Response defined as MADRS < 15 combined with patient assessed CGI-I of at least much improved
Who cannot join
- Schizophrenia or Schizoaffective disorder
- Addiction or Dependence
- Kidney disease that contraindicates lithium treatment
- Vascular or heart disease that contraindicates venlafaxine treatment
- Uncontrolled Epilepsia
- Age less that 18
- Pregnancy or Lactation
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Psychiatric clinic
Örebro, Örebro County, 70116
Psychiatric Clinic
Säter, Dalarna County, 78327
Löwenströmska sjukhuset
Stockholm, Stockholm County, 11000
Psychiatric Clinic
Uppsala, Uppsala County, 75017
About this study
Official title: Randomised Controlled Trial of Electroconvulsive Therapy (ECT) With Pharmacotherapy or Pharmacotherapy Alone in Relapse Prevention of Depression
The purpose of the study is to determine if continuation electroconvulsive therapy (ECT) is safe and effective in relapse prevention of depression.
Read the detailed description
Randomized multicenter clinical trial with two parallel groups. Patients with major depression (unipolar or bipolar), who have remitted with electroconvulsive therapy (ECT) are eligible. All patients receive pharmacotherapy (venlafaxine target dose 300mg/day, and lithium target dose 0,5-0,8 mmol/L). The intervention is continuation unilateral ECT weekly for the first 6 weeks thereafter every 2 weeks for one year. Depressive relapse is the primary outcome measure.
- Conditions
- Depressive Disorder, Major
- Being tested
- Electroconvulsive therapy, venlafaxine, Lithium
- Keywords
- Depressive Disorder, Major, Electroconvulsive Therapy, Lithium Carbonate, venlafaxine
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive therapyProcedure or surgery
Also called ECT
unilateral briefpulse ECT weekly for the first 6 weeks thereafter every 2 weeks for a total of one year
venlafaxineDrug
Also called Efexor, Effexor
extended release target dose of 300mg/day duration of one year
LithiumDrug
Also called Lithionit, Lithobid, Eskalith
serum concentration 0,5-0,8 mmol/L, one year duration
| Study group | Role | What they receive |
|---|---|---|
| ECT+pharmacotherapy | Experimental | Unilateral brief pulse ECT weekly for 6 weeks thereafter every 2 weeks; Venlafaxine target dose 300mg/day; Lithium target dose 0,5-0,8 mmol/L. Receives: Procedure: Electroconvulsive therapy; Drug: venlafaxine; Drug: Lithium |
| pharmacotherapy | Active comparator | Venlafaxine target dose 300mg/day; Lithium 0,5-0,8 mmol/L. Receives: Drug: venlafaxine; Drug: Lithium |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS >20, psychiatric hospitalization or suicide
Measured: 1 year, all patients assessed if MADRS-S > 20 and at 2,6 and 12 months
Secondary outcomes (6)
Mini Mental State Examination
Measured: 2,6 and 12 months
ADAS-cog
Measured: 2,6 and 12 months
Autobiographical Memory Inventory -Short Form (AMI-SF)
Measured: 2,6 and 12 months patients treated in Örebro
Clinical Global Impression-Severity
Measured: 2,6 and 12 months
Udvalg for Kliniske Undersogelser (UKU)
Measured: 2, 6 and 12 months
MADRS-S Montgomery Asberg Depression Rating scale- self assessment
Measured: weekly for 6 weeks thereafter every 2 weeks for a total of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro County Council
- Sponsor type
- Other government
- Collaborators
- Uppsala-Örebro Regional Research Council
- Responsible party
- Principal investigator, prof Ingemar Engström, Örebro County Council
- Investigators
- Ingemar Engstrom, MD, PhD, Principal investigator, County Council of Orebro, University of Orebro, SwedenAxel Nordenskjold, MD, Study director, County Council of Orebro,Lars von Knorring, PhD, MD, Study director, County Council of Uppsala, University of Uppsala Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627887
- Sponsor's protocol ID
- ISRCTN40355220
- Other IDs
- ISRCTN40355220
- Status last verified
- Jun 2012
- First submitted
- 4 Jan 2008
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kellner CH, Knapp RG, Petrides G, Rummans TA, Husain MM, Rasmussen K, Mueller M, Bernstein HJ, O'Connor K, Smith G, Biggs M, Bailine SH, Malur C, Yim E, McClintock S, Sampson S, Fink M. Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE). Arch Gen Psychiatry. 2006 Dec;63(12):1337-44. doi: 10.1001/archpsyc.63.12.1337.
PubMed 17146008Sackeim HA, Haskett RF, Mulsant BH, Thase ME, Mann JJ, Pettinati HM, Greenberg RM, Crowe RR, Cooper TB, Prudic J. Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a randomized controlled trial. JAMA. 2001 Mar 14;285(10):1299-307. doi: 10.1001/jama.285.10.1299.
PubMed 11255384Brus O, Cao Y, Carlborg A, Engstrom I, von Knorring L, Nordenskjold A. Long-Term Effect of Maintenance Electroconvulsive Therapy in Patients With Depression-Data From a Small Randomized Controlled Trial. J ECT. 2024 Sep 1;40(3):169-172. doi: 10.1097/YCT.0000000000000983. Epub 2023 Dec 28.
PubMed 38232249Nordenskjold A, von Knorring L, Ljung T, Carlborg A, Brus O, Engstrom I. Continuation electroconvulsive therapy with pharmacotherapy versus pharmacotherapy alone for prevention of relapse of depression: a randomized controlled trial. J ECT. 2013 Jun;29(2):86-92. doi: 10.1097/YCT.0b013e318276591f.
PubMed 23303421
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Electroconvulsive Therapy (ECT) With Pharmacotherapy or Pharmacotherapy Alone in Relapse Prevention of Depression
- ClinicalTrials.gov ID
- NCT00627887
- Acronym / sponsor ID
- ISRCTN40355220
- Conditions
- Depressive Disorder, Major
- Keywords
- Depressive Disorder, Major, Electroconvulsive Therapy, Lithium Carbonate, venlafaxine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Örebro County CouncilOther government
- Collaborators
- Uppsala-Örebro Regional Research Council
- Study start
- Jan 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 4 Mar 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.
The purpose of the study is to determine if continuation electroconvulsive therapy (ECT) is safe and effective in relapse prevention of depression.
Detailed description
Randomized multicenter clinical trial with two parallel groups. Patients with major depression (unipolar or bipolar), who have remitted with electroconvulsive therapy (ECT) are eligible. All patients receive pharmacotherapy (venlafaxine target dose 300mg/day, and lithium target dose 0,5-0,8 mmol/L). The intervention is continuation unilateral ECT weekly for the first 6 weeks thereafter every 2 weeks for one year. Depressive relapse is the primary outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECT+pharmacotherapy | Experimental | Procedure: Electroconvulsive therapy, Drug: venlafaxine, Drug: LithiumUnilateral brief pulse ECT weekly for 6 weeks thereafter every 2 weeks; Venlafaxine target dose 300mg/day; Lithium target dose 0,5-0,8 mmol/L. |
| pharmacotherapy | Active comparator | Drug: venlafaxine, Drug: LithiumVenlafaxine target dose 300mg/day; Lithium 0,5-0,8 mmol/L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- MINI-PLUS verified major depressive episode (unipolar or bipolar).
- ECT within the last 3 weeks.
- Either Remission defined as MADRS < 10 or
- Response defined as MADRS < 15 combined with patient assessed CGI-I of at least much improved
Key exclusion criteria (7 listed)
- Schizophrenia or Schizoaffective disorder
- Addiction or Dependence
- Kidney disease that contraindicates lithium treatment
- Vascular or heart disease that contraindicates venlafaxine treatment
- Uncontrolled Epilepsia
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 therapyAlso: ECTunilateral briefpulse ECT weekly for the first 6 weeks thereafter every 2 weeks for a total of one year | Procedure or surgery | ECT+pharmacotherapy |
| venlafaxineAlso: Efexor, Effexorextended release target dose of 300mg/day duration of one year | Drug | ECT+pharmacotherapy, pharmacotherapy |
| LithiumAlso: Lithionit, Lithobid, Eskalithserum concentration 0,5-0,8 mmol/L, one year duration | Drug | ECT+pharmacotherapy, pharmacotherapy |
Primary outcome
MADRS >20, psychiatric hospitalization or suicide
Time frame: 1 year, all patients assessed if MADRS-S > 20 and at 2,6 and 12 months
6 secondary outcomes
Mini Mental State Examination
Time frame: 2,6 and 12 months
ADAS-cog
Time frame: 2,6 and 12 months
Autobiographical Memory Inventory -Short Form (AMI-SF)
Time frame: 2,6 and 12 months patients treated in Örebro
Clinical Global Impression-Severity
Time frame: 2,6 and 12 months
Udvalg for Kliniske Undersogelser (UKU)
Time frame: 2, 6 and 12 months
MADRS-S Montgomery Asberg Depression Rating scale- self assessment
Time frame: weekly for 6 weeks thereafter every 2 weeks for a total of one year
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 22 Jun 2012.
- Background: PubMed 17146008Kellner CH, Knapp RG, Petrides G, Rummans TA, Husain MM, Rasmussen K, Mueller M, Bernstein HJ, O'Connor K, Smith G, Biggs M, Bailine SH, Malur C, Yim E, McClintock S, Sampson S, Fink M. Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE). Arch Gen Psychiatry. 2006 Dec;63(12):1337-44. doi: 10.1001/archpsyc.63.12.1337.
- Background: PubMed 11255384Sackeim HA, Haskett RF, Mulsant BH, Thase ME, Mann JJ, Pettinati HM, Greenberg RM, Crowe RR, Cooper TB, Prudic J. Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a randomized controlled trial. JAMA. 2001 Mar 14;285(10):1299-307. doi: 10.1001/jama.285.10.1299.
- Derived from this study: PubMed 38232249Brus O, Cao Y, Carlborg A, Engstrom I, von Knorring L, Nordenskjold A. Long-Term Effect of Maintenance Electroconvulsive Therapy in Patients With Depression-Data From a Small Randomized Controlled Trial. J ECT. 2024 Sep 1;40(3):169-172. doi: 10.1097/YCT.0000000000000983. Epub 2023 Dec 28.
- Derived from this study: PubMed 23303421Nordenskjold A, von Knorring L, Ljung T, Carlborg A, Brus O, Engstrom I. Continuation electroconvulsive therapy with pharmacotherapy versus pharmacotherapy alone for prevention of relapse of depression: a randomized controlled trial. J ECT. 2013 Jun;29(2):86-92. doi: 10.1097/YCT.0b013e318276591f.
Related trials for Depressive Disorder, Major
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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.
Ingemar Engstrom, MD, PhD principal investigator
County Council of Orebro, University of Orebro, Sweden
Axel Nordenskjold, MD study director
County Council of Orebro,
Lars von Knorring, PhD, MD study director
County Council of Uppsala, University of Uppsala Sweden
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Electroconvulsive therapy, venlafaxine and Lithium in people with Depressive Disorder, Major, run by Örebro County Council at 4 sites in Sweden.
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 4 inclusion and 7 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 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
MADRS >20, psychiatric hospitalization or suicide (time frame: 1 year, all patients assessed if MADRS-S > 20 and at 2,6 and 12 months). 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 NCT00627887, which also lists 4 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 22 Jun 2012.