1. Study identification
EU PAS Register NumberEUPAS12174
Official titleSicide attempts and medications. A retospective case-control study
Study title acronymSuicide attempt and medications
Study typeObservational study
Brief description of the studySeveral medications have been related to suicide. We have set up a protocol to study the relationship between some psycotropics and suicide attempt. This is a case-control study gathering information from clinical records of Psychiatric Unit in Spain.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsCESME
Department/Research groupCentro de Estudios sobre la Seguridad de los Medicamentos
Organisation/affiliationUniversidad de Valladolid
Details of (Primary) lead investigator
Title Professor
Last name Carvajal
First name Alfonso
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/01/201515/01/2015
Start date of data collection15/01/201515/01/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report17/08/201622/01/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherHospital100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Carvajal
First name Alfonso
Address line 1Ramón y Cajal 7
Address line 2
Address line 3
CityValladolid
Postcode47005
CountrySpain
Phone number (incl. country code)34610535853
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Carvajal
First name Alfonso
Address line 1Ramón y Cajal 7
Address line 2
Address line 3
CityValladolid
Postcode47005
CountrySpain
Phone number (incl. country code)34-983263021
Alternative phone number
Fax number (incl. country code)34983254924
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Suicide attempt
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects2000
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Administrative database, e.g. claims database
11. Scope of the study
What is the scope of the study?
Risk assessment
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
To learn the risk os suicidal behaviour associated with several medications
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Case-control study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
Logistic regression
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted