Clinical trial NCT00437385: Evaluation of Three Continuation Therapies After ECT Concerning Efficacy and Cognition in Severly Depressed Patients
Official title: Phase 1 Study: Evaluation of Three Continuation Therapies After Acute Electroconvusive Therapy (ECT) Concerning Efficacy and Cognition in Severly Depressed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Major Depression
Keywords: therapy resistant depression, severe depression
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2007-02-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

* Evaluation of the efficacy of three continuation treatments aimed at preventing relapses after acute ECT
* Examination of the cognitive side effects and the changes of cognitive psychological variables during acute and continuation treatment

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.

Eligibility criteria: Inclusion Criteria:

* Major depressive episode (unipolar)
* Response to acute ECT (at least 50% reduction in HAMD)
* Capacity to consent
* Sufficient comprehension of the German language

Exclusion Criteria:

* Schizophrenia, schizoaffective disorder, or other psychosis
* Amnestic disorder, dementia, or delirium
* Pregnancy
* Epilepsy
* Current alcohol or substance abuse or dependence
* CNS disease or brain injury not associated with psychotropic drug exposure
* ECT in the past 3 months
* Acute suicidality
* Judiciary hospitalization

Primary outcomes:
measure: Score on HAMD after 6 and 12 months
timeFrame: 6 and 12 months after enetering continuation phase
Secondary outcomes:
measure: Relapse rate after 6 and 12 months
timeFrame: 6 and 12 months after enetering continuation phase
measure: Response and remission rates after 6 and 12 months
timeFrame: 6 and 12 months after enetering continuation phase
measure: Scores on MADRS, BDI, and CGI after 6 and 12 months
timeFrame: 6 and 12 months after enetering continuation phase
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Psychiatry, Charité University Medicine, Campus Benjamin Franklin, Berlin, Germany
Study officials:
affiliation: Department of Psychiatry, Charité University Medicine, Campus Benjamin Franklin, Berlin, Germany
name: Malek Bajbouj, PhD
role: STUDY_CHAIR
affiliation: Department of Psychiatry and Psychotherapy, University Medicine, Freiburg, Germany
name: Eva-Lotta Brakemeier, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Psychology, Humboldt-University, Berlin, Germany
name: Norbert Kathmann, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.