Depressive Disorder, Major
Conditions
Keywords
Depressive Disorder, Major, Electroconvulsive Therapy, Lithium Carbonate, venlafaxine
Brief summary
The purpose of the study is to determine if continuation electroconvulsive therapy (ECT) is safe and effective in relapse prevention of depression.
Detailed description
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.
Interventions
PROCEDUREElectroconvulsive therapy
unilateral briefpulse ECT weekly for the first 6 weeks thereafter every 2 weeks for a total of one year
DRUGvenlafaxine
extended release target dose of 300mg/day duration of one year
DRUGLithium
serum concentration 0,5-0,8 mmol/L, one year duration
Sponsors
Uppsala-Örebro Regional Research Council
Örebro County Council
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. MINI-PLUS verified major depressive episode (unipolar or bipolar). 2. ECT within the last 3 weeks. 3. Either Remission defined as MADRS \< 10 or 4. Response defined as MADRS \< 15 combined with patient assessed CGI-I of at least much improved
Exclusion criteria
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. Age less that 18 7. Pregnancy or Lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MADRS >20, psychiatric hospitalization or suicide | 1 year, all patients assessed if MADRS-S > 20 and at 2,6 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| ADAS-cog | 2,6 and 12 months |
| Autobiographical Memory Inventory -Short Form (AMI-SF) | 2,6 and 12 months patients treated in Örebro |
| Mini Mental State Examination | 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 |
| Clinical Global Impression-Severity | 2,6 and 12 months |
Countries
Sweden
Outcome results
None listed