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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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The purpose of this study is to evaluate three different continuation treatments after acute ECT concerning efficacy and impact on cognition in severly depressed patients.
BACKGROUND While electroconvulsive therapy (ECT) in major depression is effective, high relapse rates and cognitive effects limit its long-term use. Continuation treatment after ECT with combinations of C-ECT or psychotherapy and medication may decrease relapse rates and cognitive side effects while changing cognitive psychological variables like dysfunctional attitudes in the long-term.
CENTRAL RESEARCH QUESTIONS
METHODS In a prospective, randomized, controlled, long-term study we assign 60 depressed ECT responder either to antidepressant treatment alone, or C-ECT plus medication, or cognitive behavioral group therapy plus medication. Depressive symptoms and cognition were assessed before, during, immediately after acute ECT and two, four, six, and 12 months during continuation therapy.
HYPOTHESES It is hypothesized that the use of combination continuation therapies after effective ECT leads to lower HAMD scores and lower relapse rates than the standard treatment with antidepressants alone after 6 months. In addition, we assume that the CBT group will establish more functional macro-patterns than the somatic treatments in the long term and will have the lowest HAMD scores and relapse rates after 1 year. With regard to the cognitive side effects, the autobiographical memory is expected to be the only specific part of memory being affected negatively by ECT in the short and long term.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Continuation-Medication with Antidepressants (after WBS Guidelines) |
|
| 2 | Experimental | Continuation-ECT with Antidepressants |
|
| 3 | Experimental | Continuation-Psychotherapy (Cognitive Behavioral Group Psychotherapy including the "Situational Analysis" of CBASP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCAs, SSRIs, NARIs, SNRIs, Lithium | Drug | Antidepressant, dosage, and duration are chosen due to the guidelines of the WFSBP (Bauer et al. 2002) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Score on HAMD after 6 and 12 months | 6 and 12 months after enetering continuation phase |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse rate after 6 and 12 months | 6 and 12 months after enetering continuation phase | |
| Response and remission rates after 6 and 12 months | 6 and 12 months after enetering continuation phase | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malek Bajbouj, PhD | Department of Psychiatry, Charité University Medicine, Campus Benjamin Franklin, Berlin, Germany | Study Chair |
| Eva-Lotta Brakemeier, MA | Department of Psychiatry and Psychotherapy, University Medicine, Freiburg, Germany | Principal Investigator |
| Norbert Kathmann, PhD | Department of Clinical Psychology, Humboldt-University, Berlin, Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, Charité University Medicine, Campus Benjamin Franklin, Berlin, Germany | Berlin | State of Berlin | 14050 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11255384 | 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. | |
| 10839336 | Background |
| Label | URL |
|---|---|
| Related Info | View source |
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| Electroconvulsive therapy | Procedure | ECT treatment is administered three times per week on non-successive weekdays and according to existing standards. Treatment lasts for at least three weeks (nine ECT sessions). Psychopharmacological treatment is continued during ECT treatment. Patients receive ultrabrief pulse (0.3 ms), unilateral treatment at a frequency of 40-100 Hertz. Stimulation is applied to the non-dominant hemisphere, according to the d'Elia electrode positioning paradigm. All patients are initially treated with right unilateral stimulation and in case of non-response switched to bilateral treatment. Stimulus intensity is chosen according to individual seizure threshold and administered at 2.5 to 6-fold intensity. During the ECT session, patients are anesthetized, under the influence of a muscle relaxant, and monitored regarding their vital functions. |
|
| Cognitive behavioral group therapy | Behavioral | The continuation-psychotherapy (continuation cognitive behavioral therapy, C-CBT) sample took part in a newly developed cognitive behavioral group therapy program called "EffECTive". This therapy program was developed within the EffECT-project (Brakemeier et al. 2005), to fit the specific target group of patients finished with acute ECT-treatment. EffECTive is a group therapy that combines several aspects of existing cognitive-behavioral depression manuals with new elements (e.g., the situational analysis from CBASP, McCullough 2000), to fit the target group. Therapy sessions were held once a week and include approximately 15 sessions until follow-up. |
|
| Scores on MADRS, BDI, and CGI after 6 and 12 months |
| 6 and 12 months after enetering continuation phase |
| Lisanby SH, Maddox JH, Prudic J, Devanand DP, Sackeim HA. The effects of electroconvulsive therapy on memory of autobiographical and public events. Arch Gen Psychiatry. 2000 Jun;57(6):581-90. doi: 10.1001/archpsyc.57.6.581. |
| 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. |
| 24462229 | Derived | Brakemeier EL, Merkl A, Wilbertz G, Quante A, Regen F, Buhrsch N, van Hall F, Kischkel E, Danker-Hopfe H, Anghelescu I, Heuser I, Kathmann N, Bajbouj M. Cognitive-behavioral therapy as continuation treatment to sustain response after electroconvulsive therapy in depression: a randomized controlled trial. Biol Psychiatry. 2014 Aug 1;76(3):194-202. doi: 10.1016/j.biopsych.2013.11.030. Epub 2013 Dec 12. |
| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017367 | Selective Serotonin Reuptake Inhibitors |
| D000068760 | Serotonin and Noradrenaline Reuptake Inhibitors |
| D008094 | Lithium |
| D004565 | Electroconvulsive Therapy |
| ID | Term |
|---|---|
| D014179 | Neurotransmitter Uptake Inhibitors |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018377 | Neurotransmitter Agents |
| D018490 | Serotonin Agents |
| D045505 | Physiological Effects of Drugs |
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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