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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN40355220 |
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| Name | Class |
|---|---|
| Uppsala-Örebro Regional Research Council | OTHER |
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The purpose of the study is to determine if continuation electroconvulsive therapy (ECT) is safe and effective in relapse prevention of depression.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| pharmacotherapy | Active Comparator | Venlafaxine target dose 300mg/day; Lithium 0,5-0,8 mmol/L. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroconvulsive therapy | Procedure | unilateral briefpulse ECT weekly for the first 6 weeks thereafter every 2 weeks for a total of one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| MADRS >20, psychiatric hospitalization or suicide | 1 year, all patients assessed if MADRS-S > 20 and at 2,6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mini Mental State Examination | 2,6 and 12 months | |
| ADAS-cog | 2,6 and 12 months | |
| Autobiographical Memory Inventory -Short Form (AMI-SF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ingemar Engstrom, MD, PhD | County Council of Orebro, University of Orebro, Sweden | Principal Investigator |
| Axel Nordenskjold, MD | County Council of Orebro, | Study Director |
| Lars von Knorring, PhD, MD | County Council of Uppsala, University of Uppsala Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Clinic | Säter | Dalarna County | 78327 | Sweden | ||
| Löwenströmska sjukhuset |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17146008 | Background | 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. | |
| 11255384 |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004565 | Electroconvulsive Therapy |
| D000069470 | Venlafaxine Hydrochloride |
| D008094 | Lithium |
| D016651 | Lithium Carbonate |
| ID | Term |
|---|---|
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
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| venlafaxine | Drug | extended release target dose of 300mg/day duration of one year |
|
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| Lithium | Drug | serum concentration 0,5-0,8 mmol/L, one year duration |
|
|
| 2,6 and 12 months patients treated in Örebro |
| Clinical Global Impression-Severity | 2,6 and 12 months |
| Udvalg for Kliniske Undersogelser (UKU) | 2, 6 and 12 months |
| MADRS-S Montgomery Asberg Depression Rating scale- self assessment | weekly for 6 weeks thereafter every 2 weeks for a total of one year |
| Stockholm |
| Stockholm County |
| 11000 |
| Sweden |
| Psychiatric Clinic | Uppsala | Uppsala County | 75017 | Sweden |
| Psychiatric clinic | Örebro | Örebro County | 70116 | Sweden |
| Background |
| Sackeim 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. |
| 38232249 | Derived | Brus 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. |
| 23303421 | Derived | Nordenskjold 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. |
| D011580 | Psychological Techniques |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
| D002254 | Carbonates |
| D000468 | Alkalies |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D018020 | Lithium Compounds |