REmission MEchanisms in Depression

ISRCTN	ISRCTN89615545
DOI	https://doi.org/10.1186/ISRCTN89615545
Protocol serial number	4357
Sponsor	University of Manchester (UK)
Funder	Medical Research Council (MRC) (UK)

Submission date: 29/04/2010
Registration date: 29/04/2010
Last edited: 26/11/2019

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ian Anderson
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Scientific title	REmission MEchanisms in Depression
Study acronym	REMEDi
Study objectives	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(s)	Stockport LREC approved on the 3rd December 2007
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Citalopram
Primary outcome measure(s)	Baseline neuronal responses predicting outcome a 8 weeks
Key secondary outcome measure(s)	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
Completion date	31/05/2010

Eligibility

Participant type(s)	Mixed
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	72
Key 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
Key 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
Date of first enrolment	01/04/2008
Date of final enrolment	31/05/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Neuroscience and Psychiatry Unit

Manchester
M13 9PT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are available upon request from Prof. Emeritus Ian M Anderson (ian.anderson@manchester.ac.uk) in an anonymised form and in keeping with MRC data sharing guidance.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2012	26/11/2019	Yes	No
Results article	results	15/03/2019	26/11/2019	Yes	No
Results article	results	01/09/2009	26/11/2019	Yes	No
Results article	results	01/12/2013	26/11/2019	Yes	No
Results article	results	01/09/2009	26/11/2019	Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

26/11/2019: Publication references and IPD sharing statement added.
25/11/2019: No publications found. Verifying results with principal investigator.
14/07/2016: No publications found, verifying study status with principal investigator.