Combination of pharmacotherapy with electroconvulsive therapy in prevention of relapse in major depressive disorder: a randomised, placebo controlled, double-blind study
| ISRCTN | ISRCTN28600786 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28600786 |
| Secondary identifying numbers | AY0022 |
- Submission date
- 28/03/2008
- Registration date
- 09/05/2008
- Last edited
- 13/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Aysegul Yildiz
Scientific
Scientific
Seferihisar Cad No.6
Camli Villalari Sitesi Villa
14 Camli Koyu Guzelbahce
Izmir
35310
Türkiye
Study information
| Study design | Randomised, double-blind, placebo-controlled, parallel-arms trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | A new strategy of continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a controlled trial |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | sertraline hydrochloride |
| Primary outcome measure | 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 study start date | 05/04/2004 |
| Completion date | 01/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 46 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 05/04/2004 |
| Date of final enrolment | 01/02/2007 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Seferihisar Cad No.6
Izmir
35310
Türkiye
35310
Türkiye
Sponsor information
Individual sponsor (Turkey)
Other
Other
Prof Aysegul Yildiz
Seferihisar Cad No.6
Camli Villalari Sitesi Villa
14 Camli Koyu Guzelbahce
Izmir
35310
Türkiye
Funders
Funder type
Industry
Investigator award from the Pfizer Pharmaceuticals (USA)
No information available
Dokuz Eylul University (Turkey)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2010 | 13/04/2021 | Yes | No |
Editorial Notes
13/04/2021: Publication reference added.
