Major depressive disorder Mental and Behavioural Disorders Depressive episode
Conditions
Interventions
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
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 admin
Sponsors
Individual sponsor (Turkey)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of relapse. The criterion for relapse was a mean MADRS score of at least 16 that is maintained over 2 consecutive visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Estimated mean time to relapse. | — |
Countries
Turkey
Outcome results
None listed