Condition category
Mental and Behavioural Disorders
Date applied
28/03/2008
Date assigned
09/05/2008
Last edited
09/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Aysegul Yildiz

ORCID ID

Contact details

Seferihisar Cad No.6
Camli Villalari Sitesi Villa
14 Camli Koyu Guzelbahce
Izmir
35310
Turkey

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

Sponsor information

Organisation

Individual sponsor (Turkey)

Sponsor details

Prof Aysegul Yildiz
Seferihisar Cad No.6
Camli Villalari Sitesi Villa
14 Camli Koyu Guzelbahce
Izmir
35310
Turkey

Sponsor type

Other

Website

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

Publication citations

Additional files

Editorial Notes