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ISRCTN
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ISRCTN28600786
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ClinicalTrials.gov identifier
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Public title
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Combination of pharmacotherapy with electroconvulsive therapy in prevention of relapse in major depressive disorder: a randomised, placebo controlled, double-blind study
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Scientific title
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A new strategy of continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a controlled trial
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Acronym
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N/A
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Serial number at source
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AY0022
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Study hypothesis
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1. The frequency of relapse of depressive symptoms will be lower in the group with concomitant antidepressant treatment after the 4th electroconvulsive therapy (ECT) compared to the group taking placebo.
2. The frequency of relapse of depressive symptoms will be lower in the group with concomitant antidepressant treatment after the 4th ECT compared to the group taking antidepressant treatment after the 8th ECT.
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Ethics approval
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Approved by the Dokuz Eylul University Institutional Review Board, Izmir, Turkey on 03/10/2002 (version 0.0). Amendments were approved on the following dates:
Version 0.1: 16/07/2003
Version 0.2: 03/10/2004
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Study design
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Randomised, double-blind, placebo-controlled, parallel-arms trial.
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Countries of recruitment
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Turkey
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Disease/condition/study domain
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Major depressive disorder
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Participants - inclusion criteria
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1. Be at least 18 years old, male and female
2. Diagnosis of major depressive disorder on the structural clinical interview for the Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV)
3. Montgomery-Asberg Depression Rating Scale >22 at screening
4. Providing informed consent
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Participants - exclusion criteria
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1. Currently pregnant, planning to become pregnant, or breast feeding
2. History of bipolar disorder, schizophrenia, schizoaffective disorder, nonmood disorder psychosis, neurological illness
3. History of ECT within the past 6 months
4. Drug screen positive for any drug of abuse at screening, active substance abuse in the past 2 weeks or substance dependence in the past 2 months (except nicotine and caffeine)
5. Severe medical illness that markedly increases the risks of ECT (e.g. unstable or severe cardiovascular conditions, aneurysm or vascular malformation susceptible to rupture, severe chronic obstructive pulmonary disease)
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Anticipated start date
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05/04/2004
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Anticipated end date
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01/02/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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46
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Interventions
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Consented subjects who met the inclusion and exclusion criteria were consulted by an anesthesian and cardiologist before starting ECT. Each subject received 8 effective bilateral ECT at a frequency of twice a week.
After completion of 4th ECT session, the participants were randomly allocated to the following three arms:
1. C-Pharm Early
2. C-Pharm Late
3. C-Pharm Placebo
Randomisation to C-Pharm Early: C-Pharm Late: C-Pharm Placebo groups was 2:2:1.
On the day of randomisation C-Pharm Early group was given sertraline hydrochloride (150 mg/day); C-Pharm Late group was first given identical placebo tablets, which was then substituted with sertraline hydrochloride (150 mg/day) after the completion of the 8th ECT. C-Pharm Placebo group was administered identical placebo tablets throughout the interventions.
Participants were evaluated weekly during the first 4 weeks, then biweekly by Montgomery-Asberg Depression Rating Scale (MADRS) throughout the study period. After the completion of the 8 ECTs, remitters in each study group were identified. To be defined as remitted, patients had to achieve a maximum score of 12 in MADRS.
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Primary outcome measure(s)
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Rate of relapse. The criterion for relapse was a mean MADRS score of at least 16 that is maintained over 2 consecutive visits.
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Secondary outcome measure(s)
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Estimated mean time to relapse.
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Sources of funding
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1. Investigator award from the Pfizer Pharmaceuticals (USA)
2. Dokuz Eylul University (Turkey)
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Trial website
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Publications
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Contact name
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Prof
Aysegul
Yildiz
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Address
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Seferihisar Cad No.6
Camli Villalari Sitesi Villa
14 Camli Koyu Guzelbahce
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City/town
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Izmir
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Zip/Postcode
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35310
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Country
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Turkey
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Sponsor
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Individual sponsor (Turkey)
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Address
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Prof Aysegul Yildiz
Seferihisar Cad No.6
Camli Villalari Sitesi Villa
14 Camli Koyu Guzelbahce
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City/town
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Izmir
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Zip/Postcode
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35310
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Country
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Turkey
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Date applied
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28/03/2008
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Last edited
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09/05/2008
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Date ISRCTN assigned
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09/05/2008
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