Depression MedDRA version: 12.0 Level: LLT Classification code 10021036 Term: Hyponatraemia MedDRA version: 12.0 Level: LLT Classification code 10017955 Term: Gastrointestinal haemorrhage MedDRA version: 12.0 Level: LLT Classification code 10040108 Term: Serotonin syndrome
Conditions
Interventions
Product Name: Citalopram
Product Code: 1 CITAL
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Citalopram
CAS Number: 59729-33-8
Concentration unit: mg milligram(s)
Concentration type: ra
Sponsors
Brighton and Sussex University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be recruited through the Care of the Elderly wards and outpatients at the Brighton and Sussex University Hospitals Trust. All patients will be 80 years or older and able to consent to take part in the study or approval to take part in the study will be obtained from an appropriate consultee. A new diagnosis of depression, to be initiated on first line treatment with serotonin re-uptake inhibitors. Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded if they are already undergoing treatment for depression with SSRIs or other therapeutic agents. Patients less than 80 years of age will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our hypothesis is that a combination of an age-related reduction in SERT activity, and specific polymorphisms in the serotonin transporter (SERT) and the 5-HT1A receptor, contribute to an increased risk of serious side effects and reduce the efficacy of SSRI treatment in older patients. Therefore, this project aims to: 1)provide a detailed examination of the development of serotonergic side effects in two groups of older depressed patients 80-85 years and greater than 85 years on SSRI treatment in secondary care over a 4 week period 2)assess treatment response using psychoanalytical tools in these two groups over this period 3)correlate these findings with the patients’ SERT and 5-HT1A genotype, and to platelet 5-HT concentration (as a marker of SERT function) 4)assess plasma citalopram concentrations and biochemical and haematological parameters for correlations with tolerability and efficacy;Secondary Objective: To produce a simple tool that will allow clinicians to screen older patients for SERT function and SERT and 5HT1A receptor polymorphism status, and therefore predict tolerability, and potential efficacy. The ultimate aim of this work will be to improve the efficiency and effectiveness of depression treatment in older patients,as demonstrated by a reduction in patient harm and an improvement in patient outcomes.;Primary end point(s): To establish the correlation between treatment response in elderly depressed patients and SERT levels and/or SERT and 5-HT1A genotype | — |
Countries
United Kingdom
Outcome results
None listed