Major depressive disorder Mental and Behavioural Disorders Depression
Conditions
Interventions
Current interventions as of 25/07/2008:
The patients will have ECT three times weekly in the index series (before the trial).
ECT: During the trial the patients have u
Sponsors
Orebro County Council (Orebro lans landsting) (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 25/07/2008: 1. Mini International Neuropsychiatry Interview Plus (MINI-PLUS) verified major depressive episode (unipolar or bipolar) 2. ECT within the last 3 weeks 3. Either remission defined as Montgomery-Asberg Depression Rating Scale (MADRS) less than 10, or 4. Response defined as MADRS less than 15 combined with patient assessed Clinical Global Impressions-Improvement Scale (CGI-I) of at least much improved Previous inclusion criteria: 1. Patients treated with ECT for Diagnostic and Statistical Manual of mental disorders - Fourth Edition (DSM-IV-TR) diagnosis of major depression 2. Remission (less than 10 on the Montgomery-Asberg Depression Rating Scale [MADRS]) 3. Informed consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 25/07/2008: 1. Schizophrenia or schizoaffective disorder 2. Addiction or dependence 3. Kidney disease that contraindicates lithium treatment 4. Vascular or heart disease that contraindicates venlafaxine treatment 5. Uncontrolled epilepsia 6. Aged less that 18 years 7. Pregnancy or lactation Previous exclusion criteria: 1. Bipolar 1 disorder 2. Schizophrenia and schizoaffective diagnosis 3. Abuse or dependence diagnosis 4. Kidney disease 5. Heart disease 6. Epilepsia 7. More than three weeks since index ECT 8. Under 16 years of age, more than 10 on the MADRS after 12 index ECT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse, defined as either: 1. Rehospitalisation in a psychiatric ward, or 2. More than 20 on the MADRS interview. MADRS-S self-assessment is provided weekly for the first six weeks then every other week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 21/12/2007: 1. Memory problems measured with: 1.1. Mini Mental State Examination (MMSE) 1.2. Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog) 1.3. At one site the Autobiographical Memory Inventory Short Form will also be used 2. Medication Side-effects measured with the Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale Patients are assessed at 2 months, 6 months and 12 months after randomization and at relapse. Previous secondary outcome measures: 1. Side-effects measured with the Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale self-assemessment 2. Memory problems measured with Mini Mental State Examination (MMSE), Squire Subjective Memory Questionnaire and the Autobiographical Memory Inventory Short Form 3. Quality of life is measured with 36-item Short Form health survey (SF-36) Patients are assessed after 2 months, 6 months and 12 months and at relapse. | — |
Countries
Sweden
Outcome results
None listed