Clinical trial NCT00627887: Randomised Controlled Trial of Electroconvulsive Therapy (ECT) in Relapse Prevention of Depression
Official title: Randomised Controlled Trial of Electroconvulsive Therapy (ECT) With Pharmacotherapy or Pharmacotherapy Alone in Relapse Prevention of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depressive Disorder, Major
Keywords: Depressive Disorder, Major
Electroconvulsive Therapy
Lithium Carbonate
venlafaxine
Lead sponsor: Örebro County Council
Sponsor class: OTHER_GOV
Collaborators: name: Uppsala-Örebro Regional Research Council
First posted: 2008-03-04
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: MADRS >20, psychiatric hospitalization or suicide
timeFrame: 1 year, all patients assessed if MADRS-S > 20 and at 2,6 and 12 months
Secondary outcomes:
measure: Mini Mental State Examination
timeFrame: 2,6 and 12 months
measure: ADAS-cog
timeFrame: 2,6 and 12 months
measure: Autobiographical Memory Inventory -Short Form (AMI-SF)
timeFrame: 2,6 and 12 months patients treated in Örebro
measure: Clinical Global Impression-Severity
timeFrame: 2,6 and 12 months
measure: Udvalg for Kliniske Undersogelser (UKU)
timeFrame: 2, 6 and 12 months
measure: MADRS-S Montgomery Asberg Depression Rating scale- self assessment
timeFrame: weekly for 6 weeks thereafter every 2 weeks for a total of one year
Other outcomes:
Locations:
city: Sater
country: Sweden
facility: Psychiatric Clinic
state: Dalarna
city: Orebro
country: Sweden
facility: Psychiatric clinic
city: Stockholm
country: Sweden
facility: Löwenströmska sjukhuset
city: Uppsala
country: Sweden
facility: Psychiatric Clinic
Study officials:
affiliation: County Council of Orebro, University of Orebro, Sweden
name: Ingemar Engstrom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: County Council of Orebro,
name: Axel Nordenskjold, MD
role: STUDY_DIRECTOR
affiliation: County Council of Uppsala, University of Uppsala Sweden
name: Lars von Knorring, PhD, MD
role: STUDY_DIRECTOR
References:
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: 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: Nordenskjold A, von Knorring L, Ljung T, Carlborg A, Brus O, Engstrom I. Continuation electroconvulsive therapy with pharmacotherapy versus pharmacotherapy alone for prevention of relapse of depression: a randomized controlled trial. J ECT. 2013 Jun;29(2):86-92. doi: 10.1097/YCT.0b013e318276591f.