ISRCTN ISRCTN89615545
DOI https://doi.org/10.1186/ISRCTN89615545
Secondary identifying numbers 4357
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

Study website

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

Study designRandomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific titleREmission MEchanisms in Depression
Study acronymREMEDi
Study objectivesWe 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) studiedTopic: Mental Health Research Network, Primary Care Research Network for England; Subtopic: Depression, Not Assigned; Disease: Depression, All Diseases
Intervention8 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Citalopram
Primary outcome measureBaseline neuronal responses predicting outcome a 8 weeks
Secondary outcome measures1. 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 study start date01/04/2008
Completion date31/05/2010

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 72; UK Sample Size: 72
Key inclusion criteriaDepressed 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 criteriaDepressed 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 enrolment01/04/2008
Date of final enrolment31/05/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Neuroscience and Psychiatry Unit
Manchester
M13 9PT
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

Oxford Road
Manchester
M13 9PL
England
United Kingdom

Website http://www.manchester.ac.uk/
ROR logo "ROR" https://ror.org/027m9bs27

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPhD thesis:
Arnone D (2011) Imaging structure and function in recovery from depression. Awarded by the University of Manchester for the degree of PhD in the Faculty of Medical and Human Sciences
IPD sharing planThe 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

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.