The relationship between anaesthetic induction agent type or dose and clinical outcome in patients with depression undergoing electroconvulsive therapy (ECT)
| ISRCTN | ISRCTN83454584 | 
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83454584 | 
| Secondary identifying numbers | N0084132839 | 
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 05/12/2014
- 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
        
    
                    
                        
    
        
            
            Record updated in last year
        
    
                    
                    Plain English summary of protocol
Not provided at time of registration
Contact information
                                            Dr Godfrey Bwalya
Scientific
                                        Scientific
                                                Miranda House
Gladstone Street
Hull
HU3 2RT
United Kingdom
                                                
Study information
| Study design | Randomised controlled trial | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Randomised controlled trial | 
| Study setting(s) | Hospital | 
| Study type | Treatment | 
| Scientific title | The relationship between anaesthetic induction agent type or dose and clinical outcome in patients with depression undergoing electroconvulsive therapy (ECT) | 
| Study objectives | Is there a relationship between the effect of a dose or type of anaesthetic induction agent on seizure duration and clinical outcome in patients undergoing electrical convulsive therapy for depression? | 
| Ethics approval(s) | Not provided at time of registration | 
| Health condition(s) or problem(s) studied | Mental and Behavioural Disorders: Depression | 
| Intervention | Randomised 40 subjects to each of the four anaesthetic induction agent groups. Pre-ECT Hamilton Depression Rating Scale (HAM-D) score. Six sessions of ECT, observed motor seizure during, electroencephalogram (EEG) seizure duration in seconds. Post ECT HAM-D score done 1-2 days following ECT treatment. | 
| Intervention type | Procedure/Surgery | 
| Primary outcome measure | Hamilton Depression Scale scores and data collection forms. | 
| Secondary outcome measures | Not provided at time of registration | 
| Overall study start date | 01/03/2003 | 
| Completion date | 01/12/2005 | 
Eligibility
| Participant type(s) | Patient | 
|---|---|
| Age group | Not Specified | 
| Sex | Not Specified | 
| Target number of participants | 160 subjects | 
| Key inclusion criteria | Not provided at time of registration | 
| Key exclusion criteria | Not provided at time of registration | 
| Date of first enrolment | 01/03/2003 | 
| Date of final enrolment | 01/12/2005 | 
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
                                            Miranda House
                                        
                                        
                                            
                                            Hull
HU3 2RT
United Kingdom
                                    HU3 2RT
United Kingdom
Sponsor information
                                            Department of Health
Government
                                        Government
                                                Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
                                                
| Website | http://www.dh.gov.uk/Home/fs/en | 
|---|
Funders
Funder type
Hospital/treatment centre
                                                The North and South Bank Research and Development Consortium (UK)
                                            
                                            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 | 

