Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AY0022
Study information
Scientific title
A new strategy of continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a controlled trial
Acronym
Study hypothesis
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.
Ethics approval
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
Study design
Randomised, double-blind, placebo-controlled, parallel-arms trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Major depressive disorder
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
sertraline hydrochloride
Primary outcome measures
Rate of relapse. The criterion for relapse was a mean MADRS score of at least 16 that is maintained over 2 consecutive visits.
Secondary outcome measures
Estimated mean time to relapse.
Overall trial start date
05/04/2004
Overall trial end date
01/02/2007
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
46
Participant exclusion criteria
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)
Recruitment start date
05/04/2004
Recruitment end date
01/02/2007
Locations
Countries of recruitment
Turkey
Trial participating centre
Seferihisar Cad No.6
Izmir
35310
Turkey
Funders
Funder type
Industry
Funder name
Investigator award from the Pfizer Pharmaceuticals (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Dokuz Eylul University (Turkey)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary