Combination of pharmacotherapy with electroconvulsive therapy in prevention of relapse in major depressive disorder: a randomised, placebo controlled, double-blind study

Not Applicable

Completed

• Conditions: Major depressive disorder; Mental and Behavioural Disorders; Depressive episode

• Registration Number: ISRCTN28600786
• Lead Sponsor: Individual sponsor (Turkey)

Brief Summary

2010 results in https://pubmed.ncbi.nlm.nih.gov/19935091/ (added 13/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2007-02-01
• Study Start: 2008-05-09
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 46

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Estimated mean time to relapse.