REmission MEchanisms in Depression
ISRCTN | ISRCTN89615545 |
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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
Contact information
Prof Ian Anderson
Scientific
Scientific
Neuroscience and Psychiatry Unit
Room G704 Stopford Building, Stopford Building
Oxford Road
Manchester
M13 9PT
United Kingdom
Study information
Study design | Randomised interventional treatment trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | GP practice |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Citalopram |
Primary outcome measure | 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 study start date | 01/04/2008 |
Completion date | 31/05/2010 |
Eligibility
Participant type(s) | Mixed |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Planned Sample Size: 72; UK Sample Size: 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
- England
- United Kingdom
Study participating centre
Neuroscience and Psychiatry Unit
Manchester
M13 9PT
United Kingdom
M13 9PT
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
Oxford Road
Manchester
M13 9PL
England
United Kingdom
Website | http://www.manchester.ac.uk/ |
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https://ror.org/027m9bs27 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
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 | |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | PhD 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 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 |
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.