E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021036 |
E.1.2 | Term | Hyponatraemia |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017955 |
E.1.2 | Term | Gastrointestinal haemorrhage |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10040108 |
E.1.2 | Term | Serotonin syndrome |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | 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 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The last visit of the last subject undergoing the trial |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |