Condition category
Mental and Behavioural Disorders
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
14/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.remedistudy.co.uk

Contact information

Type

Scientific

Primary contact

Prof Ian Anderson

ORCID ID

Contact details

Neuroscience and Psychiatry Unit
Room G704 Stopford Building
Stopford Building
Oxford Road
Manchester
M13 9PT
United Kingdom

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

http://www.manchester.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Publication citations

Additional files

Editorial Notes

14/07/2016: No publications found, verifying study status with principal investigator