Topic: Mental Health Research Network, Primary Care Research Network for England
Conditions
Interventions
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.
Sponsors
University of Manchester (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline neuronal responses predicting outcome a 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed