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Schema-ECT


- candidate number16438
- NTR NumberNTR4433
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-feb-2014
- Secondary IDsNL47246.018.13 CCMO
- Public TitleSchema-ECT
- Scientific TitleSchema-ECT: a novel treatment for severe depression
- ACRONYMSchema-ECT
- hypothesisWe recently found that memories can be weakened by applying electroconvulsive therapy (ECT) shortly after reactivation of a memory (Kroes et al., 2014). This suggests that reactivation of negative schemas just prior to ECT may also weaken those schemas. According to the cognitive theory of depression this will lead to the recovery from depression and will additionally reduce the risk to relapse, but this has not yet been investigated. In this study, we aim to investigate the efficacy of “schema-ECT” and hypothesize that repeated reactivation of depressive schemas prior to ECT weakens negative schemas, increases the efficacy of the ECT course, and reduces the relapse rate after the reduction of the ECT session frequency or discontinuing ECT. In addition to our main aim, we will investigate whether the clinical response to ECT response is associated with changes in neurobiological biomarkers using neuroimaging scans and blood samples obtained from the venous catheter, and whether these biomarkers at baseline can predict treatment response.
- Healt Condition(s) or Problem(s) studiedDepression, Electroconvulsive therapy, Reconsolidation
- Inclusion criteria• Diagnosis of major depressive disorder (MDD) without psychotic symptoms assessed with the Mini Neuropsychiatric Interview (MINI) • Clinical indication for ECT • 18-70 years of age • Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements
- Exclusion criteria• Bipolar disorder, schizophrenia, primary alcohol or drug abuse, or any cognitive disorder as assessed with the Mini Neuropsychiatric Interview (MINI) • Patients with MR contraindications such as metal implants or claustrophobia will be excluded from the neuroimaging study
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 17-feb-2014
- planned closingdate
- Target number of participants98
- InterventionsThe subjects will be randomised to schema-ECT or control-ECT. ECT is conducted as usual according to national guidelines in both patient groups (Nederlandse Vereniging voor Psychiatrie, 2010). In the schema group, ECT is preceded by a structured interview using the arrow-down technique, a technique known from cognitive-behavioral therapy (CBT) to reactivate negative schemas. In the control condition, patients will be interviewed about details that are also of clinical relevance but are not expected to activate depressive schemas.
- Primary outcome• Hamilton Rating Scale for Depression (HAM-D) scores • Time to relapse/recurrence
- Secondary outcome• Hippocampal magnetic resonance spectroscopy (MRS) • Structural connectivity using diffusion tensor imaging (DTI) • Functional connectivity using functional magnetic resonance imaging (fMRI) • Biomarker levels determined from blood samples
- TimepointsPre-treatment baseline measures are obtained before start of ECT. During treatment, HAM-D scores are obtained at least every 6 sessions to follow treatment response. Within one week after the last ECT session (and before the transition of possible maintenance ECT (<1 session per week)), all parameters are assessed again as post-treatment measurement. Thereafter, patients are evaluated at 2-week intervals the first 8 weeks, and at 4-week intervals for the remaining 12 weeks to determine possible treatment relapse.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. G. Wingen, van
- CONTACT for SCIENTIFIC QUERIESDr. G. Wingen, van
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Hersenstichting Nederland
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD14-feb-2014 - 7-apr-2014


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