Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4357
Study information
Scientific title
REmission MEchanisms in Depression
Acronym
REMEDi
Study hypothesis
We will recruit 48 unmedicated depressed participants aged 18 - 55 years with a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) major depressive episode and 24 age and sex matched controls. Depressed participants will be scanned using magnetic resonance imaging, before and after administration of 8 weeks treatment with daily citalopram (20 mg, increasing to 40 mg at week 4 if necessary). Half of the controls will be retested after 8 weeks but receive no treatment. Also, prior to oral administration of citalopram, depressed participants will be randomised to receive citalopram or saline infusion in the scanning protocol. Depressed participants will be treated by the clinical research fellow and monitored for treatment response, side effects and suicidal risk by face-to-face appointments at 2, 4, 6 and 8 weeks and by phone interviews at 1, 3 and 5 weeks.
Ethics approval
Stockport LREC approved on the 3rd December 2007
Study design
Randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Topic: Mental Health Research Network, Primary Care Research Network for England; Subtopic: Depression, Not Assigned; Disease: Depression, All Diseases
Intervention
8 week treatment with citalopram 20 - 40 mg, citalopram pharmacoMRI. Patients are randomised to citalopram infusion (7.5 mg) versus saline during fMRI scanning at baseline in a 3:1 ratio.
Follow up length: 2 months
Study entry: registration only
Intervention type
Drug
Phase
Not Specified
Drug names
Citalopram
Primary outcome measures
Baseline neuronal responses predicting outcome a 8 weeks
Secondary outcome measures
1. Montgomery Asberg Depression Rating Scale (MADRS), measured at baseline and 8 weeks
2. Neuronal responses to emotional processing tasks using fMRI, measured at baseline and 8 weeks depressed patients versus controls
Overall trial start date
01/04/2008
Overall trial end date
31/05/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Depressed subjects:
1. DSM-IV major depressive episode with a Montgomery Asberg Depression Rating Scale (MADRS) score greater than 20
2. Psychotropic drug-free for greater than 2 weeks (2 months for fluoxetine)
Controls:
3. Psychiatrically well
All:
4. Good physical health
5. Aged 18 - 55 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 72; UK Sample Size: 72
Participant exclusion criteria
Depressed subjects:
1. Duration of depressive episode greater than 1 year or depression superimposed on dysthymia
2. Failure to respond to 2 antidepressants given for 6 weeks at an adequate dose in current episode
3. Failure to respond to citalopram or escitalopram in current episode
4. Allergy or intolerance to citalopram or escitalopram
5. Contraindications to selective serotonin reuptake inhibitor (SSRI) treatment (e.g., history of peptic ulcer/gasterointestinal [GI] bleeding or taking non-steroidal anti-inflammatory drugs [NSAIDs], in the absence of concurrent ulcer-protective treatment)
6. Other concurrent psychotropic medication except for small stable doses of short acting hypnotics
7. Electroconvulsive therapy (ECT) or lithium in current episode
8. Significant suicidal risk or likely need for other psychiatric intervention during the study period
9. Other current co-morbid Axis I psychiatric disorders except anxiety disorders (excluding OCD) secondary to depression
10. Primary cluster A or B Axis II (personality) disorder
11. History of psychotic, bipolar or organic psychiatric disorder
Controls:
12. Personal psychiatric history including Axis II (personality) disorder
13. Significant family psychiatric history (eg psychosis, recurrent affective disorder)
14. Psychotropic medication
All:
15. Medical condition that might compromise subject safety or interfere with interpretation of results
16. History of significant head trauma (loss of consciousness greater than 5 minutes)
17. Current medication for a medical condition that would compromise subject safety or interfere with interpretation of results in the judgement of the investigator (e.g., possible exceptions intermittent analgesics, contraceptive pill, occasional inhaler for mild asthma)
18. Subjects whose English is insufficiently good to enable them to validly complete the questionnaires or perform simple computer-based tasks
19. Pregnancy or no effective contraception in women of childbearing age
20. Any illicit drug use in the last 2 months and a lifetime history of a DSM-IV substance or alcohol misuse disorder
21. Current Alcohol use above 14 units/week for women and 21 units/week for men
22. Excessive caffeine use (greater than 6 cups of coffee/day)
23. Smoking greater than 10 cigarettes/day
24. Contraindications to scanning (determined by standard screening instrument)
25. Likely not to be able to complete the full study for any reason
Recruitment start date
01/04/2008
Recruitment end date
31/05/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Neuroscience and Psychiatry Unit
Manchester
M13 9PT
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
Oxford Road
Manchester
M13 9PL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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