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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00361062
Other study ID # hae064910706ctil
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2006
Est. completion date March 2012

Study information

Verified date February 2020
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

SSRIs are the first line of therapy for anxiety and depressive disorders and for many other clinical diagnoses. One of the most disturbing side effects that is observed is a tendency towards aggressiveness among patients receiving medications from this group, mainly during the first month of therapy. Aggressive behavior tends to occur in some individuals but not in others. In some sub-groups of people, personality and character traits might make a person more prone to aggressive behavior.

In this study the investigators try to estimate the tendency towards aggressive behavior in patients prescribed to a medication from the SSRI group. By using a comparative computer simulation they hope to be able to detect delicate changes and to maybe get some clues of the personalities prone to aggressive behavior in the future.


Description:

Selective serotonin reuptake inhibitors (SSRIs) became the first line therapy for anxiety and depressive disorders and for many other clinical diagnoses. One of the most disturbing side effects that is observed is a tendency towards aggressiveness among patients receiving medications from this group, mainly during the first (one month) period of therapy. Aggressive behavior tends to occur in some individuals but not in others. Until now most of the cases and reports in the literature demonstrate the extreme events of aggressive behavior. These personality or any other character traits that are more prone to develop aggressiveness have not been studied and it is not clear if this side effect manifests itself just in the extreme rare cases or if it is a more common phenomenon that occurs in a wider group of people.

In this study we try to estimate the tendency towards aggressive behavior of patients prescribed to a medication of the SSRI group. By using a comparative computer simulation we hope to be able to detect more delicate changes and maybe to get some clues of the personalities prone to aggressive behavior in the future.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 2012
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age above 18 years

- Instructed by his/her family physician to start taking a medicine in the SSRI group

Exclusion Criteria:

- According to the family practitioner's record: under SSRI, SNRI, or NRI treatment during the previous 3 months or at the time of entry into the study.

- Diagnosed with schizophrenia or active psychosis or impaired judgment

- Anti-social personality disorder

- Drug use or alcohol abuse

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
comparative computer simulation
comparative computer simulation assessing the level of aggressiveness before and after the beginning of SSRI treatment.

Locations

Country Name City State
Israel HaEmek Medical Center Afula Ysrael Valley
Israel HaEmek Medical Center Afula

Sponsors (1)

Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary aggressiveness level whithin 1 month
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